#jadelle rods

[nixs-thoughts]

Got my birth control implants (Jadelle rods) replaced yesterday and my arm is so swollen today. My arm is super sore from them having to dig around in my arm to take the old ones out, but soooooo worth it because now I'm safe for 4 years! I know a lot of people dislike this form of contraception because of the side effects but I've been lucky enough to have minimal problems with them for the last 10 years. Best of all it was completely free, because it was covered by the sexual health clinic in my area!

[turniplemonade]

me update

i finally got a slightly better solution for supposed endometriosis symptoms. however getting a jadelle rod inserted in your arm is a pretty unpleasant experience. they don’t really prepare you or anything. they just say lie down and then numb you and cut you arm. the doctor who did it (i dislike him ) fucked up mid way and PULLED OUT BEFORE SHOVING IT BACK IN AGAIN. yeah wasnt a fan of that. its been like 4 days since then and thankfully its healing alright. today i took off some of the dressing to change the bandages and clean up any blood left over and i was fine. but 5 minutes later i got so nauseous 😭 i guess being able to see and feel something under your skin fucks with your head a bit. hopefully that goes away. anyways! this is a good start if it works for me

[frosinapopovskigrad701]

Week 3.1 SDL

Review of Contextual Knowledge 

Looking at 2 academic articles/ journals and 2 news stories 

Academic articles:

“It was my own decision”: The transformational shift that influences a woman’s decision to use contraceptives covertly. (2022, May 2). BioMed Central. https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-022-01731-z#:~:text=Conclusions,make%20decisions%20about%20contraceptive%20use

Family planning enables women to pursue their reproductive objectives and is a crucial component of sexual and reproductive health and rights. Even though there have been an improvement in the services of Family Planning for both low and middle income countries; women are still being faced with obstacles. Such as unfair gender-based power dynamics have become a major barrier to women’s ability to make decisions about their reproductive health. Some women therefore decide to take contraception in private and without their husbands “approval” and knowledge. Due to socio- cultural barriers and gender inequality frequently affects how women decide whether to take contraception. Due to the negative effects of recurrent pregnancies and the large families, women had lacked decision making more over their fertility. Women felt comfortable participating in CCU because they thought their husbands did not comprehend the implications or recognise their pain, which allowed them to conceal the information. This marked a significant change in a woman’s attitude of who has the right to decide whether to use contraception. Importantly, health professionals should take care not to undermine women’s self-assurance while supporting their freedom to make decisions about contraceptive use.

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https://journal.nzma.org.nz/journal-articles/the-inequity-of-access-to-contraception-for-women-in-aotearoa-an-unfair-unsafe-and-ineffective-system

The World Health Organization and the United Nations came together to address that safe, successful, easily available and appropriate contraceptions are a fundamental human right. The journal looks at how these burden’s have been placed on women whether it’s related to child birth and contraceptives all these burdens fall to be unfair, ineffective, and inequity. The most common method of contraceptions used across Aotearoa. New Zealand is oral contraception; most commonly known as ‘the pill’. The pill is mostly used by women of a European/other descent over Maori women. Pasifik women are most likely to be given other forms of contraceptions such as the, Jadelle implants also known as ‘the rod’. However there has been studies to show that the rod has a lot of issues when it comes to removal. Such as insertion, breakthrough, bleeding and more. This journal in a sense is call to action to the all women’s needs and especially the ones that are least privileged to have first priority. Needing a clear vision and plan for an appropriate system for the reproductive and sexual health system in New Zealand and what it should now look like. Overall looking at the differences that women of an European descent are commonly given for contraception in comparison to women that are of a Pasifik decent e.g Maori. 

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New stories:

“Warning over young people getting birth control advice on social media”

By Larissa Howie, 1News Producer, Wed Jan 25th

1news.co.nz/2023/01/25/warning-over-young-people-getting-birth-control-advice-on-social-media/

“New research is warning there could be an increase in unplanned pregnancies as young people seek birth control advice from online influencers.”

In the article it talks about social media influencer, Lucy Britland, 23-years-old talks about how she had no idea of any birth control options. And wasn’t taught about any methods at school. Which lead her to look at social media for advice on birth control methods. Studies from University of Delaware found that viewers on social media are more likely to get content about stopping hormonal contraceptions rather than informing them how to use them safely and/or for safe sex. Medical Advisor from Family Planning in New Zealand, Dr Beth Messenger she’s worried that the advice that individuals receive on social media influencer’s is promoting unsafe sexual practices. Speaking on the idea how, “there is no size fits all option when it comes to birth control.” 

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“Major barriers remain for New Zealanders accessing contraception - survey”

By Kate Nicol-Williams, 1News Reporter, September 25, 2020

1news.co.nz/2020/09/25/major-barriers-remain-for-new-zealanders-accessing-contraception-survey/

“Family Planning is calling for visits for sexual health and contraception at the doctors and other primary health care services to be free to improve access to the medication which prevents pregnancy.”

This article talks on how sourcing and getting a contraceptive is typically a long process. Liz Kelly, Porirua Whanau Centre chief executive believes that is should be more simplified down for individuals and a lot easier to source. This will therefore then allow less unwanted pregnancies to come about. Speaking on how phone calls to doctor appointments should be free if they are to talk about sexual health issues. It talks on how many women across the NZ have to think on what to prioritizing their money. So if it is between getting “the pill” or feeding the kids at home. Many tend to go op for feeding their kids. In this article is also looks at studies from Victoria University students where their supporting the idea that doctor visits that are for contraceptives should be free. Michael Turnball agrees that this stigma on contraceptives should be removed. Turnball also speaks on how making them a lot more accessible will allow the topic to be normalized and getting in touch about sexual health a lot easier and less nerve racking. Making it free and easily accessible will allow things like what happened to Anna-Grace Somerfield, Victoria University Feminist Organisation president waited nearly two months to get the IUD implant from Family Planning; after funding. Due to it being cheaper to get from Family Planning rather than from her usual doctors. 

As for lesbian and bisexual women Zianna Mcleod, Victoria University Women’s Collective co-president speaks on how it’s a very heteronormative system. And how it’s a struggle to find affordable oral dams for protection from any STI. After raising the issue to her GP, her GP had said “ She said her GP advised her to cut them out from latex gloves.” Mcleod then goes on to speak on other issues she was faced with contraceptives at 15 years old. 

[biomedgrid]

Biomed Grid | A Multicentred Phase III Comparative Study between Single Rod Implant Monoplant® and Double Rod Implant Indoplant®

Abstract

Objective: To analyze to determine the effectiveness, safety, and time of both contraceptive methods between single rod implant monoplant® and double rod implant indoplant®.

Design/data identification: Clinical trial, ‘Open’ (‘open label ‘Randomized Clinical Trial).

Materials and methods: This study is a phase III clinical trial, conducted randomized and multicentre, comparing two types of contraceptive implants, namely Monoplant® and Indoplant® performed in Indonesian healthy women. Random blocks of tithe allocation and randomly assigned divided by 5 Monoplants and 5 Indoplants.

Results: Based on the interim results obtained from examining the twenty-fourth month this can be concluded as follows: all centre have completed the number of research subjects, the length of recruitment of subjects extends between 5.5 months to 16.5 months, continuity up to 24 months for contraception implantation of monoplant® or Indoplant® is still good, discontinued use for 24 months totaling 50 subjects, namely 27 subjects for monoplant® and 23 subjects for indoplant®, the main cause of discontinuation for both types of contraception is a disruption of menstrual patterns, there is one case of pregnancy that is most likely due to the initial selection error of the acceptor, there were 7 subjects who had to be removed because they wanted more children even though they had previously agreed to use implants for 3 years, there is no significant difference in levonorgestrel levels in the 24th month between monoplant® contraception and indoplant® contraception, the levonorgestrel levels of the two study groups in the 24th month were mostly located between 200 to 400 picograms which were still actively preventing ovulation.

Conclusion: There is no significant difference the effectiveness, safety, and time in levonorgestrel levels in the 24th month between single rod implant monoplant® and double rod implant indoplant®.

Keywords: Single Rod; Implant; Contraception

Introduction

Levonorgestrel (LNG) implant is the first contraception made in the 1960s. At that time pill contraception containing LNG was widely used, along with a new generation of intrauterine device (IUD) which was also successfully made. Whereas in Indonesia, the form or type of implant first introduced in 1982, Norplant®, which is a 6-stem implant with progesterone LNG active ingredient with 36 mg LNG concentration and effective for 5 (five) years. In 1989, contraception single rod was first introduced through phase II clinical trial research in Indonesia. This contraception has effectiveness for 3 (three) years and is named Implanon® with 3-keto desogestrel active ingredients produced by PT. Organon. Then the implant method was reintroduced which consisted of 2 (two) implants and had 3 years of effectiveness as Jadena® or Jadelle. Besides that, a new implant method, known as Indoplant®, was made up of 2 implants and had effectiveness for 3 years with the active ingredient levonorgestrel [1-3].

The limited variation in the choice of implants in Indonesia and for the implant of the new single rod known only Implanon®, it is very necessary to develop another single rod implant in Indonesia. Seeing the high public interest in the long-term contraceptive implant method compared to the IUD method, PT Triyasa Nagamas Farma tried to develop single rod implants, at affordable prices without reducing the effectiveness and security that was named Monoplant®. Monoplant contains 160 mg of levonorgestrel (LNG), with a tube length of 42.50-44.50 mm and a diameter of 2.52-2.72 mm with effectiveness for 3 (three) years. It is expected that Monoplant® single rod implants can provide effectiveness, the same safety as other implants and easier installation. Phase III clinical trial study on Comparison of contraceptives studies in single rod Monoplant®, with implants of double rod Indoplant®, is a continuation of phase II clinical trials, namely Pharmacokinetic and Pharmacodynamic Study of Monoplant® carried out in 2010. Agency POM RI recommends that before Phase III clinical trials be carried out, phase II clinical trials need to be done first, considering that Monoplant® is a new contraceptive technique or method of single rod contraception that will be developed in Indonesia. If from the results of Pharmacokinetic and Pharmacodynamic Monoplant ® within 6 months LNG levels in the blood show levels of 200 pg / ml or more, then Phase III Clinical Test studies are permitted. From 2007 to 2010 Monoplant® Phase II Clinical Tests were carried out in the Jakarta centre on 30 female subjects with 36 months of observation. The results of this study show that LNG levels for 12 months using Monoplant® averaged above 200 pg / ml (260.81 + 97.25). This figure shows that Monoplant has met the requirements set by BPOM RI, so Phase Clinical Tests III can be implemented. However, LNG levels in the blood fluctuate; in the 18th month LNG levels dropped and the 24th month rose again. Thus BPOM RI recommends, in phase III clinical trials, this study also looks at LNG levels in the blood of subjects using Monoplant® and Indoplant® in 5 (five) observation points, namely before being installed, at 6 months of use, 12 months, 24 months and 36 months of use [4-8].

Materials and Methods

This study is a phase III clinical trial, ‘Open’ (‘open label ‘Randomized Clinical Trial), conducted randomized and multicentre, comparing two types of contraceptive implants, namely Monoplant ® and Indoplant® performed in Indonesian healthy women. Random blocks of tithe allocation and randomly assigned divided by 5 Monoplants and 5 Indoplants.

The sample is calculated statistically, with a sample size formula for comparison of proportions between two sample research groups (Pocock): using the formula above, the number of subjects for each group treatment was obtained by 399. Based on consideration of the drop-out (approximate drop-out) of around 10%, the total sample required was 444 subjects for each group treatment and rounded up to 450 subjects for each group or group.

The total sample observed in this study: 450 subjects of Monoplant ® users and 450 subjects of women using Indoplant® in 5 (five) centre in Indonesia, namely Jakarta, Semarang, Surabaya, Palembang and Makassar. Each centre recruits 180 subjects (90 Monoplant acceptors and 90 Indoplant acceptors).

Subjects included in this study have fulfilled all of the following criteria: women of childbearing age aged 20 - 35 years (sexually active), physically and mentally healthy, not pregnant, still having active sexual relations so that they still have the risk of becoming pregnant, not exposed to hormonal contraception in the last 3 months, already got an explanation and understood the purpose, risks and benefits of the research and signed the informed consent, willing to return to the clinic for a repeat visit, willing to only use implants during the study in the next 3 (three) years.

A woman is excluded as the subject of this study if she experiences one of the following histories or events: has a family history of all types of cancer, abnormal or undiagnosed genital bleeding, severe thromboembolism or cardiovascular, have mental illness, depression, epilepsy, tuberculosis, often severe headaches, having a history of diabetes mellitus, have a history of liver disease or active liver disease, in regular care or just with drugs that induce liver enzymes, such as: barbiturates, phenytoin, carbamazepine or rifampicin, hypertension (systolic> 160 mmHg; diastolic> 100 mmHg), heavy hirsutism, participate in other clinical research activities in the last three months.

Observations on subjects were conducted for 3 years. Blood collection for LNG level examination was carried out in a subsample (33 subjects) for each implant of Monoplant and Indoplant, especially on subjects in the Jakarta centre. Examination of LNG levels in the blood is carried out at PT. Equilab International.

Results

This progress report basically displays the results of phase III clinical trials and results of examination of LNG in the blood for 24 months using implants of Monoplant and Indoplant, because the return visit data that is complete and can be analyzed to date is data up to a 24-month return visit. Phase III clinical trials were carried out on 450 Monoplant and 450 Indoplant subjects, which were conducted in 5 (five) research centre. While LNG levels in the blood are only carried out in one research centre, the Jakarta centre, which was conducted on 33 Monoplant user sub-samples and 33 sub-samples of Indoplant® users Table 1 shows the results of the subject according to the research centre and type of implant. In the table, it can be seen that in approximately 18 months, each centre has collected 180 subjects or 900 total subjects in 5 (five) research centre.

Nearly all centre cannot meet the number of subjects within the set time. Among the 5 centre, which are the fastest and according to the time of the initial recruitment, which for approximately 6 months is the Palembang centre (6 months). The recruitment time for the Jakarta centre is 12 months, Semarang is 15 months, Surabaya is 13 months and Makassar is 17 months. The extension of the subject recruitment time is because implant services are now easily accessible to almost all government and private health facilities that work with BPJS and do not pay, making it difficult to get prospective subjects to participate in this clinical trial. Another reason is, besides the strict exclusion criteria such as having to be hormone free in the last 3 months and the narrow age limit set (Table 1).

Table 1: Subject achievement according to research centre and type of implant.

There is no difference in systole or diastole between Indoplant and Monoplant groups, as well as between centre. The systole pressure in Semarang centre is the highest compared to other centre with a value between 117.0 + 10.0 mmHg for Monoplant and 117.9 + 10.6 for Indoplant. The lowest sistole was found in Makassar centre namely 109.4 + 11.4 (Monoplant) and 109.3 + 10.3 (Indoplant). The lowest diastole was found in Surabaya centre for Monoplant and Indoplant subjects (73.8 +7.6 mmHg and 74.6 + 8.2 mmHg).

Obstetric history seen from the results of IVA test, number of parities, number of pregnancies, menstrual pattern, desire to have more children and breastfeeding. The results of the analysis showed that the subjects who received Monoplant or Indoplant had an average of children born alive between 2-4 children. The average number of children is found in Makassar centre, especially for Monoplant subjects while for Indoplant subjects in Palembang centre. The Semarang centre has the lowest average child described from Monoplant or Indoplant. There is no difference in the number of children born alive which means between Monoplant and Indoplant subjects, judging from the level of parity.

Most of the total subjects who took part in this study especially 4 research centre did not want to add more children; even Semarang centre are mostly 90 percent (Monoplant) and 84.4 percent (indoplant) already don’t want to add more children.

Seen from breastfeeding status at the time of recruitment, more than half of Monoplant subjects in the Semarang and Jakarta centre were found not breastfeeding, namely 57.8 percent and 52.2 percent. While the other three centre (Makassar, Surabaya and Palembang) mostly breastfeed at the time of recruitment. A similar pattern is found in Indoplant users, in the Surabaya, Semarang, Jakarta centre, which is 51.1 percent, 58.9 percent, 56.7 percent, most of whom are not breastfeeding. While the other two centre (Palembang, Makassar) are mostly breastfeeding at the time of recruitment.

To fulfill the inclusion requirements, the subjects were asked whether in the last 3 months they had used hormonal contraception. According to the history of hormonal use, most subjects had used hormonal contraception more than three months ago, especially the type of injection. Centre with the highest proportion did not use hormones in the past 3 months, for Monoplant subjects namely Semarang and Surabaya centre, 86.7 percent and 80.0 percent. The same centre was also experienced for Indoplant subjects, namely 85.6 percent and 87.8 percent.

Most of the subjects, both Monoplant and Indoplant said that they had no difficulty at the time of the implant placement. Only the Palembang and Semarang centre say there is a 1.1 percent difficulty for Monoplant. As for the installation of Indoplants, there was 1.1 percent difficulty in the Palembang centre, 2.2 percent found in Semarang and Surabaya centre. While this shows the level of difficulty of implant placement of Indoplant stem II is relatively more than Monoplant. There was no significant difference seen from the length of installation of the two types of implants. The median duration of Monoplant installation is 3.23 minutes (minimum 0.48 and maximum 15 minutes) while for Indoplant is 3.75 minutes (minimum 0.83 and maximum 15.25 minutes).

Figure 1: Mean weight and pulse for 24 months.

Until now, follow-up or repeat visits from several subjects have been running for 36 months. However, the complete re-visit up to now is a 24-month visit, while the 30-month and 36-month visit is not complete. So that the return visit that can be analyzed in full is data up to a 24-month return visit. For data analysis, further research will be immediately proposed when recording acceptor health data on the 30th birthday visit and the 36th month visit is complete Figure 1 shows that from the start of the implant placement to the 24-month, there did not appear to be a change in the average body weight and pulse. There was a slight fluctuation in the two variables, but still within the normal range for the two study groups.

In addition to body weight and pulse, it turned out that changes in systolic and diastolic blood pressure in the two study groups also tended to be stable from the beginning to the twenty-fourth month (Figure 1).

Figure 2: Mean systolic dan diastolic for 24 months.

Figure 2 shows that the subject’s systolic and diastolic blood pressure up to a 24-month did not show any significant changes and is still in a normal condition.

The tendency of weight stability, pulse rate, and systolic and diastolic blood pressure shows a high level of security from the cardiovascular aspect for users of the two types of implants being studied. Cardiovascular disorders can be categorized as a systemic disorder that is quite serious and can trigger other organic disorders (Figure 2).

Figure 3: Dyspareunia complaints for 24 months.

Subject complaints about health in the form of pain around the reproductive organs or known as dyspareunia after the use of Monoplant and Indoplant found in the first month, third, sixth, and twelfth. Dyspareunia complaints tend to be higher in Monoplant subjects than the Indo-plant. Within a period of 6 months, there was a noticeable increase in complaints of dyspareunia for these two implants, but in the 12th month there was a slight increase in complaints of dyspareunia to 1.9 percent for Monoplant and 2.3 percent for Indoplant. In the 18th and 24th months there was also an increase in dyspareunia complaints in both groups which reached 3.3%, but this fluctuation in complaints of dyspareunia was still within normal limits (Figure 3).

Hormonal use for some subjects can cause complaints of breast pain. The same pattern with dyspareunia complaints also appears here. After observing for 24 months the use of implants of Monoplant and Indoplant, there was a decrease in pain complaints in the breast. In Monoplant subjects, the incidence of breast pain dropped from 4.5 percent in the first month to 0.5 percent in the twelfth month and twenty-four. For Indoplant subjects, from 1.8 percent the subject fell to 0.9 percent in the 12th month even though it rose slightly again to 1.2% in the 24th month (Figure 4).

Figure 4: Breast Pain Complaints for 24 months.

The proportion of amenorrhea in Monoplant subjects ranged from 24.9 percent (month 1) to 26.8 percent (month 3) and in month 6 to 23.9 percent then slightly increased to 25.3 percent on month 12. Compared to Monoplant, Indoplant KB implants until the 6th month are relatively higher amenorrhea complaints; however, in the 12th month, amenorrhea complaints for Indoplant decreased to 22.7 percent, so complaints of Indoplant amenorrhea were slightly lower than Monoplant. In the 18th to the 24th month, complaints of amenorrhoea were a priority among the two types of contraception, which was around 16.2% (Figure 5).

Figure 5: Amenorrhea complaints for 24 months.

Up to 24 months of observations, it was seen that the continuity of the use of the Monoplant and Indoplant implants was still high; and there are no significant differences. There was a decrease in users of Monoplant by 30 subjects or 6.7 percent, so 93.3 percent still used in the 24th month. Similarly for Indoplant users, it dropped by 25 subjects or 5.6 percent, so Indoplant users on the 24th month still reached 94.4 percent. From this data it can be seen that the continuity of Monoplant users for 24 months of observation is relatively lower than the implant of Indoplant (Figure 6).

Figure 6: Continuity of Submitted Users Monoplant and Indoplant for up to 24 months of use.

Data on the continuity of Monoplant and Indoplant contraceptive use is very high until the second year of use. Of course, the level of acceptance of these acceptors still has to be analyzed for subsequent years after recording complete research data is completed.

Discussion

There are currently several innovative contraceptive implant systems under development. Monoplant is a single rod contraceptive implant and it provides contraceptive protection for 3 years. Mechanism of action of monoplant® is by ovulation inhibition and increase in viscosity of cervical mucus. The most common side effects associated with Implanon are irregular periods, weight gain, acne, headache and breast tenderness. Single rod implant will have the advantages of insertion and removal easily, the efficacy and safety are similar to Indoplant®. In terms of efficacy a quantitative measurement has been done. We measured Levonogestrel concentration in serum up till 6 months of insertion. The result is LNG serum concentration is far above the contraceptive level with mean of 337.5 pg/ml (min 200 pg/ml), giving suitability in Indonesian people and proving its efficacy. We had already performed research about the efficacy of Monoplant® and Indoplant® as contraceptive methods: a comparative study. Researchers want to determine the effectiveness, safety, and time of insertion between Monoplant® with Indoplant® to prevent pregnancy [9-11].

There was no difficulty or complication during insertion or removal in any subject. Injury to antebrachial cutaneous nerve during insertion or removal has been reported. Injury to ulnar nerve during insertion has been reported also. There was expulsion of monoplant® in one subject on 3rd day of insertion. Commonest side effect was irregular bleeding pv in 27% cases, however, only 5% cases got monoplant® removed due to this disorder. Prolonged spotting was reported in 23% cases but only 1% cases had monoplant® removal due to this disorder. 24% cases complained of amenorrhea but only 4.5% cases got removal done due to amenorrhea. Polymenorrhagia was observed in 22.5 and 16% cases got removal done due to polymenorrhagia. Gezginck et al reported less incidence of irregular bleeding P/v (17.5%), but they reported a much higher incidence of amenorrhea (41.25%). Weight gain 5 kg was observed in 7.5% cases, but no subject got removal done due to this reason. Side effects such as breast tenderness, acne, headache and dizziness, depressive mood disorders, pelvic pain and loss of libido have also been reported, but they were not observed in the present study. Hiddalgo et al. reported ovarian cysts in 5.2% cases of Implanon at 3 months, 7.2% at 6 months and 26.7% at 12 months, but they concluded that these ovarian cysts were transient and should not be interpreted as pathological. No case of ovarian cysts was observed in the present study. There was no failure of contraception in the present study. Harrison-Woolrych and Hill have reported approximate failure rate of 1 per 1000 insertions (218 out of 204486). Pregnancy due to monoplant® failure has also been reported by Hamontri and Weerkul. One case of ectopic pregnancy following monoplant® failure has been reported. Monoplant ® has to be used as a spacing method hence return of ovulation and fertility is an important parameter to be studied. 40% cases had return of ovulation within 1 month which was confirmed by progesterone estimation. Among the cases who did not adopt any alternative contraception methods, 95.8% conceived within 12 months. There was only one case who did not conceive within 1 year and she was suffering from hypothyroidism [12-15].

The data obtained showed no significant difference in the effectiveness of both contraceptive methods. In addition, side effects such as menstrual disorders and weight gain did not differ significantly in those study groups. From that research, both implants have the same effectiveness, safety, no differences in weight gain and menstrual disorders during 1, 3, and 6 months follow-up. However, the insertion of Monoplant® are faster than Indoplant®. Monoplant® can be used as a contraceptive method with the same effectiveness and safety as Indoplant®, yet with shorter insertion time [16,17] We believe that this advancement will bring a new hope to increase the efficacy of national contraception program.

Conclusion

Based on the interim results obtained from examining the twenty- fourth month this can be concluded as follows, there is no significant difference the effectiveness, safety, and time in levonorgestrel levels in the 24th month between single rod implant monoplant® and double rod implant indoplant®. Single rod implant monoplant ® is safe, effective, well accepted method of contraception. We believe that this advancement will bring a new hope to increase the efficacy of national contraception program.

Acknowledgment

Thanks are due to BKKBN, Puslitbang KB and KS team as a coordinator and management data, Triyasa team as a sponsorship and YKB as a CRO.

Read More About this Article: https://biomedgrid.com/fulltext/volume4/a-multicentred-phase-iii-comparative-study-between-single-rod-implant-monoplant%C2%AE-and-double-rod-implant-indoplant%C2%AE.000854.php

For more about: Journals on Biomedical Science :Biomed Grid | Current Issue

[markrush1]

Birth Control Implant Market to be at Forefront by 2018-2028

The birth control implants devices are very efficient in avoiding pregnancy for a brief time period. These implants contain progestin and are put sub-dermally, at the arrival of that blocks ovulation. It additionally prompts congealing of the vaginal fluid which averts from fertilization by keeping sperms from contacting the egg. It additionally stimulates diminishing of the uterine lining which makes it troublesome for the fertilized egg to connect onto it. These implants are two-sided preventative contraception as well as have low disappointment rate and if legitimately put can maintain an avert from pregnancy for a long time.

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The removal and insertion of these implants are executed by healthcare experts subsequent to thinking regarding a few different ramifications, for example, pregnancy, account of blood clots, diabetes, heart and breast cancer, kidney or liver issues. These implants are additionally regularly connected with certain reactions, for example, migraines, skin break out otherwise other pains.

These implants are now accessible and are of single bar devices comprising progestin, on the other hand, the first preventative implant which was produced and showcased as Norplant comprised of 6 bars. With additional studies and inquires about, a 2-bars system that comprised levonorgestrel along with name Jadelle was in the long run affirmed by FDA yet was not, on the other hand, showcased in the United States. Afterward, in 1988, a single bar implant comprising etonogestrel, called Implanon came into the worldwide market of birth control and was broadly acknowledged for its benefit and better outcomes. The 6 bar system was badly designed and experienced issues with removal and insertion and along these lines was in the long run expelled from the market of US. The 2-bar implant which was simpler and superior to 6-bar implant has been enrolled in 11 nations for birth control. The birth control implant creator, Merck, and Co. are eliminating its product Implanon and supplanting it with its own another product Nexplanon.

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Increasingly, there is an increase in awareness amid individuals for birth control steps. Increase in individuals undergoing treatments as well as the firm rise in the procedural bulk entails that the market might be pressed further on in the approaching years. With very little contenders as well as products in the market for these implants, the set up foremost companies have an additional favorable position. Technological developments will continue fuelling the market. On the other hand, the regulations identified with the commendation of these implants have a tendency to limit the market. The expense of these implants in addition to their failure for assurance against STD’s goes about as another downside. Progressions, for example, Nexplanon that was presented in the year 2011 by Merck and Co. in the US. The global sales of birth control implants by Merck and Co., that comprise Nexplanon and Implanon ascended to $588 million in 2015 which shows a 17% expansion contrasted with 2014.

This infers these birth control implants have a higher requirement in the US and the developing markets. Jadelle, the birth control implants, was created and authorized via the Population Council. Additionally, r&d activities relating to these implants are at present attempted with business concern with WomanCare Global. During 2016, Bayer reported its birth control implants Jadelle will be accessible at half of the cost until 2027, keeping in mind the end goal to take into account the necessities of poor people. In this manner, centering and growing its consumer base to the growing economies. The other birth control inserts, for example, Capronor™ and Nesterone™ involving distinctive progestins, as well as biodegradable pellets, rods or else microcapsules are yet in formative stages.

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[omc-juniperpublishers]

Medicinal Chemistry In The Framework Of Hormonal And Non-Hormonal Contraception-JuniperPublsihers

                   Journal of Chemistry-JuniperPublishers

                             Abstract

The paper investigates the relevance of medicinal chemistry for family planning and birth control by means of contraception. It discusses hormonal and non-hormonal methods and draws attention to the two central aspects of contraception, namely efficacy and safety of contraceptive methods.

Introduction

Day after day, millions of women worldwide engage in contraceptive pursuits to aim for birth control or family planning. For this purpose, a considerable number of contraceptive options are available, including hormonal and non-hormonal methods. Whether it is hormonal contraception in the form of Long Acting Reversible Contraception (LARC) or non-hormonal contraception in the form of natural methods, it is medicinal chemistry that lays the foundation for efficacy and safety, the two main concerns of prospective users of contraceptive methods.

Discussion

Hormonal contraception

Hormonal contraception, and in particular Long Acting Reversible Contraception (LARC) has been discussed in numerous studies, and one of the most recent ones has focused on implants and intrauterine devices as "the most highly effective" methods of contraception [1].

Implants are available in the form of one or more sub- dermally placed rods which release progestin at a slow rate. This system of sustained release relies on diffusion of steroid hormones through semipermeable pieces of plastics. The synthetic progestin passes from the plastic into the surrounding tissues and enters the circulatory system through absorption by the local capillary network. The release rate of the progestin depends on the surface area and the density of the plastic (silastic or ethylene vinyl acetate) in which the progestin is contained [2].

Jadelle and Norplant

Among the most frequently chosen implants are Jadelle and Norplant. Each one of the two Jadelle rods contains 75 mg of levonorgestrel, for a total of 150 mg. This is 66 mg less than the amount in the six Norplant capsules. While the levonorgestrel in Norplant is packed into the capsules in crystal form, the core of the Jadelle rod is a mixture of levonorgestrel and an elastic polymer (dimethylsiloxane/methylvinylsiloxane).

The daily release rate of Jadelle and Norplant has been studied for the first month, for an entire year, and for 2 years [3]. During the first 6-12 months of use, Norplant and Jadelle release a total of about 80μg (microgram) of levonorgestrel every 24 hours, which results in a plasma concentration of 0.35 ng/mL. At the end of the first year, the release rate gradually declines to a relatively constant rate of 30-35 microgram per day At 5 years, the overall release rate is 25 microgram per day, with corresponding levonorgestrel plasma levels of 0.25-0.35 ng/ mL. For comparison, progestin-only oral contraceptive pills also deliver about 80 μg of levonorgestrel per day, while combined oral contraceptives with levonorgestrel as the active progestin deliver 50-125 μg. Peak serum levels after ingestion of 75 μg of levonorgestrel reach 1.5-2.0 ng/mL; after ingestion of 150 μg of levonorgestrel, serum peaks reach 2.7-4.2 ng/mL. These serum peaks are reached within 30 minutes up to 2 hours after ingestion and are followed by a rapid decline, with an average half-life of 10-12 hours. The rapid changes are in contrast to the stable, low serum concentrations of progestin accomplished by means of the sustained-release systems.

Nexplanon

The Nexplanon implant measures 40 mm X 2.0 mm and consists of one non-biodegradable rod of 40% ethylene vinyl acetate and 60% etonogestrel (the 3-keto derivative of desogestrel), covered with a rate-controlling ethylene vinyl acetate membrane of 0.06 mm thickness. The rod contains 68 mg etonogestrel which is released at a slow rate: initially at 6070 μg/day, decreasing to 35-45 μg/day at the end of the first year, to 30-40 μg/day at the end of the second year, and further to 25 to 30 μg/day at the end of the third year The high initial rate of absorption is probably due to a significant amount of etonogestrel released from the uncovered ends of the implant. Peak serum concentrations (266 pg/mL) of etonogestrel are achieved within 1 day after insertion, with the effect of suppressing ovulation, for which only 90 or more pg/mL are required.

"Serum concentrations of etonogestrel are adequate to provide contraception for 5 years and WHO data suggest efficacy for that long" [2].

As concerns mechanisms of action, progestin-containing implants have two principal mechanisms of action, ie, inhibition of ovulation and restriction of sperm penetration through cervical mucus. Anti-estrogenic actions of the progestins affect the cervical mucus by making it viscous, scanty, and impenetrable to sperm, inhibiting in this fashion fertilization. At high doses, progestins also inhibit gonadotropin secretion, preventing in this fashion follicular maturation and ovulation. This dual effect allows contraceptive efficacy to be sustained even though ovulation is not consistently inhibited in etonogestrel implant users toward the end of the 3-year period of use."Even if follicles grow during use of progestin implants, oocytes are not fertilized. If the follicle ruptures, the abnormalities of the ovulatory process prevent release of a viable egg. Although progestins suppress endometrial activity, which makes the endometrium unreceptive to implantation, this is not a contraceptively important effect since the major mechanisms of action prevent fertilization" [2].

Concerning abortogenicity, it has been claimed that no signs of embryonic development were found in implant users, indicating that progestin implants have no abortifacient properties. Regarding abortifacient properties, it must be remembered that in the past, women were sometimes given large doses of estrogens for 4-6 days to prevent contraception after coitus during the fertile period (postcoital or "morning- after" contraception). "However, in this instance pregnancy is probably prevented by interference with implantation of the fertilized ovum rather than changes in gonadotropin secretion" [4].

For contemporary prospective users of emergency contraception Ella, Plan B One-Step, and Next Choice are available and various aspects of emergency contraception have been discussed exhaustively in a recent publication [5].

Non-hormonal methods

The mechanisms of action described above have hardly any relevance for non-hormonal contraception. However, considerations of biochemical processes are pivotal also in natural methods, ie, changes in basal body temperature due to progesterone and changes in cervical mucus structure due progesterone and estrogen. Hormonal contraception in the form of LARCs is based on progestins and in the form of oral contraceptives on estrogens and gestagens. In non-hormonal contraception, on the other hand, it is the naturally occurring hormones estrogen and progesterone that are fundamental, especially their changes in plasma concentration during the menstrual cycle.

Naturally occurring estrogens are 17 beta- estradiol, estrone, and estriol, all of which are C18 steroids. It is in the liver that estrogens are oxidized or converted to glucuronide and sulfate conjugates. Considerable amounts are secreted in the bile and absorbed into the bloodstream (enterohepatic circulation). In the urine, at least 10 different metabolites of estradiol can be found. Estrogens foster the growth of the ovarian follicles and increase the motility of the uterine tubes. In addition, they are responsible for cyclic changes in the endometrium, cervix, and vagina. As systemic effects increased secretion of angiotensinogen and thyroid-binding globuline are of importance.

Progesterone is a C21 steroid secreted by the corpus luteum, the placenta, and (in small amounts) the follicle. 17alpha- Hydroxyprogesterone is obviously secreted along with estrogens from the ovarian follicle, and its secretion corresponds to that of 17 beta-estradiol. Progesterone has a brief half-life, and it is converted in the liver to pregnanediol, which is conjugated to glucuronic acid and excreted in the urine.

In women the plasma progesterone level is approximately 0.9 ng/mL during the follicular phase of the menstrual cycle. Late in the follicular phase, progesterone secretion begins to increase, and during the luteal phase, the corpus luteum produces large quantities of progesterone so that ovarian secretion increases about 20-fold. "The result is an increase in plasma progesterone to a peak value of approximately 18ng/mL (60 nmol/L)" [4].

For non-hormonal contraception, especially for the basal body temperature (BBT), it is important to note that progesterone is thermogenic "and is probably responsible for the rise in basal body temperature at the time of ovulation" [4]. The effects of progesterone, like those of other steroids, are brought about by an action on DNA to initiate synthesis of new mRNA. Substances that mimic the action of progesterone are at times called progestational agents, gestagens, or progestins. Along with synthetic estrogens they are used as oral contraceptive agents.

The effects of estrogens and progesterone described above are the basis for the so-called fertility awareness-based methods, also called natural family planning or periodic abstinence. They have been described extensively as early as 2000 by German research [6]. The most effective among them, the so-called symptothermal method (Pearl index of 0.8) combines the principles of two other methods, namely basal body temperature and Billings Ovulation method (or Zervixschleimstruktur- Methode nach Billings) [7].

Concerning the basal body temperature method physiologists emphasize the easy practicability and argue that a convenient and reasonably reliable indicator of the time of ovulation is a change - usually a rise - in the basal body temperature. "Women interested in obtaining an accurate temperature chart should use a thermometer with wide gradations and take their temperatures (oral or rectal) in the morning before getting out of bed. The cause of the temperature change at the time of ovulation is probably the increase in progesterone secretion, since progesterone is thermogenic" [4].

With respect to the ovulation method physiological research emphasizes the importance of the cervical mucus. "Estrogen makes the mucus thinner and more alkaline, changes that promote the survival and transport of sperm. Progesterone makes it thick, tenacious, and cellular. The mucus is thinnest at the time of ovulation, and its elasticity, or spinnbarkeit, increases so that by mid-cycle, a drop can be stretched into a long, thin thread that may be 8-12 cm or more in length"[4].

Conclusion And Implications

As can be seen from the foregoing discussion, medicinal chemistry is at the heart of any form of contraception, clarifying not only efficacy but also safety of contraceptive methods. Whether a woman opts for a hormonal or non-hormonal method, safety is a primary concern. When safety is understood as protection against sexually transmitted diseases, the recommendations of the FDA should be heeded: "Except for abstinence, latex condoms are the best protection against HIV/AIDS and other STls"[8]. When safety is understood as protection against harm, ie, adverse events, one of the non-hormonal methods will be the first choice. When safety is understood as not causing death or any serious complication, one of the hormonal methods will suffice, although bleedings, amenorrhea, perforations, expulsions, and pelvic inflammatory disease -- associated with the most efficacious methods -- might be considered by some women as sufficiently serious to discontinue a particular method, albeit it is hailed by some authors as "safe" [1].

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Birth Control Implant Market Global Industry Analysis, Size, Sales and Forecast By 2025

The birth control implants devices are very efficient in avoiding pregnancy for a brief time period. These implants contain progestin and are put sub-dermally, at the arrival of that blocks ovulation. It additionally prompts congealing of the vaginal fluid which averts from fertilization by keeping sperms from contacting the egg. It additionally stimulates diminishing of the uterine lining which makes it troublesome for the fertilized egg to connect onto it. These implants are two-sided preventative contraception as well as have low disappointment rate and if legitimately put can maintain an avert from pregnancy for a long time.

The removal and insertion of these implants are executed by healthcare experts subsequent to thinking regarding a few different ramifications, for example, pregnancy, account of blood clots, diabetes, heart and breast cancer, kidney or liver issues. These implants are additionally regularly connected with certain reactions, for example, migraines, skin break out otherwise other pains.

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These implants are now accessible and are of single bar devices comprising progestin, on the other hand, the first preventative implant which was produced and showcased as Norplant comprised of 6 bars. With additional studies and inquires about, a 2-bars system that comprised levonorgestrel along with name Jadelle was in the long run affirmed by FDA yet was not, on the other hand, showcased in the United States. Afterward, in 1988, a single bar implant comprising etonogestrel, called Implanon came into the worldwide market of birth control and was broadly acknowledged for its benefit and better outcomes. The 6 bar system was badly designed and experienced issues with removal and insertion and along these lines was in the long run expelled from the market of US. The 2-bar implant which was simpler and superior to 6-bar implant has been enrolled in 11 nations for birth control. The birth control implant creator, Merck, and Co. are eliminating its product Implanon and supplanting it with its own another product Nexplanon.

Increasingly, there is an increase in awareness amid individuals for birth control steps. Increase in individuals undergoing treatments as well as the firm rise in the procedural bulk entails that the market might be pressed further on in the approaching years. With very little contenders as well as products in the market for these implants, the set up foremost companies have an additional favorable position. Technological developments will continue fuelling the market. On the other hand, the regulations identified with the commendation of these implants have a tendency to limit the market. The expense of these implants in addition to their failure for assurance against STD's goes about as another downside. Progressions, for example, Nexplanon that was presented in the year 2011 by Merck and Co. in the US. The global sales of birth control implants by Merck and Co., that comprise Nexplanon and Implanon ascended to $588 million in 2015 which shows a 17% expansion contrasted with 2014.

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This infers these birth control implants have a higher requirement in the US and the developing markets. Jadelle, the birth control implants, was created and authorized via the Population Council. Additionally, r&d activities relating to these implants are at present attempted with business concern with WomanCare Global. During 2016, Bayer reported its birth control implants Jadelle will be accessible at half of the cost until 2023, keeping in mind the end goal to take into account the necessities of poor people. In this manner, centering and growing its consumer base to the growing economies. The other birth control inserts, for example, Capronor™ and Nesterone™ involving distinctive progestins, as well as biodegradable pellets, rods or else microcapsules are yet in formative stages.

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Other contraceptive methods

Post partum use of contraceptive pill

Generally, fertility returns back to a woman at a varied rate, with the earliest known ovulation to be 27 days after delivery. This means that no contraception is required until day 21 post partum. If a woman is <6 months post partum, amenorrhoeic, fully breastfeeding (i.e. every 4 hours during the day and 6 hours overnight), this is seen to be 98% effective at preventing pregnancy (i.e. the lactational amenorrhoea method). However, some women may still prefer to use additional contraception during this time.

Post partum use of POP:

Suitable for both breastfeeding and non-breastfeeding

If started before day 21, there is no need for extra contraception methods and the woman should be fully protected. If started after day 21, use additional contraception for 2 days and exclude pregnancy if unprotected sex had occurred prior

If regular menstruation, start during days 1-5 of the menstrual cycle and no extra precautions will be needed. If it is started after this, exclude pregnancy and follow the 2 day rule

Post partum use of COC:

Not suitable for breastfeeding, suitable for non-breastfeeding. COC are contraindicated <6 weeks post partum in someone breastfeeding

Can be started from day 21 post partum if no other risk factors for thrombosis are present (i.e. immobility, BMI >30, pre eclampsia). Use the 7 day rule unless it is started on day 1-5 of the period

Breastfeeding:

COC is contraindicated < 6 weeks postpartum

Previous studies suggested COC may have affected the quality and supply of breastmilk and that hormones could affect infant growth before 6 months, however recent UK medical criteria has been changed and COC can now be used from 6 weeks post partum

Current practice still recommend not commencing COC until after 6 months post partum if breastfeeding 

Depo-Provera

Depo-Provera is a long acting reversible contraceptive that helps improve compliance and reduce failure rates. It is used for reliable reversible contraception not requiring daily routine

It is the only injectable option available in NZ and contains progestogen (medroxyprogesterone 150mg)

Given as IM injection into the outer buttock every 12 weeks

Failure rate 2/1000 per year

Mechanism of action: suppresses ovulation

Efficacy is not reduced by obesity or enzyme inducing medication

It is suitable for both breast feeding and non-breastfeeding women from 21 days post partum (produce licence for use after 6 weeks)

Used when:

Estrogen is contraindicated or not tolerated

Heavy or painful periods

Not appropriate for women who are planning a pregnancy in the near future as fertility may be delayed (~5.5 months + duration of last injection)

Contraindications:

Current breast cancer

Severe liver disease

History of severe arterial disease

Side effects:

Irregular bleeding - most common in the first 1-2 injections, however amenorrhoea increases with duration of uses. It is unusual to have monthly bleeding

Decreased bone density - consider other risk factors for osteoporosis (e.g. coeliac, anorexia, smoker, corticosteroids)

Weight gain - can cause increase 3kg in a year. Women under 18 with BMI >30 and women who gain >5% initial weight in first 6 months are at greater risk of further weight gain

Progestogen only implant (Jadelle)

Contains levonorgestrel 75mg in a rod

Mechanism of action: inhibits ovulation in 45-85% of cycles, thickens cervical mucous and has effects on the endometrium

Advantages:

Very low failure rates

No studies have shown increased pregnancy rates due to high body weights (up to 149kg)

Fit and forget, lasts for up to 5 years

Funded in NZ but may have cost for insertion and removal

WINZ will fund for beneficiaries

No long term effects on fertility, rapid return on removal of device

Safe to use post partum, breastfeeding and non-breastfeeding from day 21

May cause amenorrhoea

Very few contraindications as per POP

Disadvantages:

Requires minor surgical procedure for insertion and removal. Removals can be difficult if incorrect insertion

Irregular bleeding may occur in up to 20% of women - most common reason for removal

Side effects are similar to POP

Starting date: Ideally inserted day 1-7 of menstrual cycle for immediate contraceptive cover, and if inserted after day 7 it will require you to follow the 7 day rule

Inauterine devices

Copper IUD

Long acting reversible contraceptive

Available as: Cu load TT380 (Standard duration 10-12 years, short device 5 years) or CU choice 375 (duration 5 years)

Any copper IUD inserted in a woman after 40 years can safely be left in until menopause

Mechanism of action: Cytotoxic inflammatory reaction in endometrium which is spermicidal. May also inhibit sperm mobility in cervical mucous

Considered to be a pre-fertilisation method for contraception, however if fertilisation did occur then it prevents implantation of sperm to egg

Can be used as emergency contraceptive (inserted after sex) which it will be used as a post fertilisation contraceptive effect

Can be used in any age group

Advantages:

Long acting reversible

Very effective, failure rate is 1-2% in 5 years

Non-hormonal

Easily removed

No evidence of increased cancer risk

Very few absolute contraindications

Devices are subsidised although may be cost for insertion and removal

Disadvantages:

Insertion required by experienced doctor or nurse

May be cost associated with insertion (can be funded by WINZ if beneficiary)

May be discomfort associated with insertion

Some risks associated with insertion such as infection or perforation

May be expelled (5%) if unrecognised risk of pregnancy

Periods may be heavier, longer or more painful - most common reason for discontinuation

Absolute contraindications:

Active or very recent pelvic/endometrial/cervical infection

Between 48 hours and 4 weeks postpartum

Some uterine abnormalities

Gynaecological cancers

Allergy to copper

Wilson’s disease

Mirena

Releases levonorgestrel, lasting for 5-7 years

Efficacy: very low failure rate 1-2% over 5 years of use

Mechanism of action: Suppresses effect on endometrium, effects on cervical mucous making it unfavourable to sperm so fertilisation is prevented and inhibits normal sperm movement in uterus and fallopian tubes

Most women do continue to still ovulate

Advantages:

Long acting reversible

Reduces menstrual loss and improves period pain

Menstrual loss reduced by 71-95% at 6 months

65% women have amenorrhoea after 12 months

Very good option for women in their 40′s with endometriosis

Hormonal but lowest dose of any hormonal contraception as effect is largely local so very little systemic absorption

Efficacy is not affected by other medication

Can be used as a component of combined HRT - good option if menopausal symptoms and still need contraception

Hormonal side effects are uncommon

Can be used postpartum in both breast feeding and non-breastfeeding from 4 weeks

Disadvantages:

May cause irregular bleeding in first 3-6 months

Requires insertion/removal by trained doctor or nurse

Risks associated with insertion include infection and perforation

Cost - only funded in some woman through WINZ or meet certain haematological criteria

Contraindications:

Breast cancer within preceding 5 years

Active or very recent pelvic/endometrial/cervical infection

Between 48 hours and 4 weeks postpartum

Some uterine abnormalities

Gynaecological cancers

Wilson’s disease

Sexual health screening

When women present requesting contraception, it is ideal to offer advice around screening for:

Sexually transmitted infections

STI may be present if women present with symptoms of breakthrough bleeding on the pill. Other symptoms may include urinary frequency, urgency, change in vaginal discharge, post coital bleeding or pelvic pain

Cervical screening

Recommended for women from age 20 who have been sexually active

Repeat smear 12 months after first smear, then 3 yearly thereafter if normal

Continue until age 70

Domestic violence/sexual abuse

HPV vaccination

HPV infection is associated with genital warts, cervical cancer and some head and neck cancers

It is free to both male and female aged 9-26

Free to non-residents <18

Available through school based immunisation programs in year 8, Family Planning clinics, GP clinics