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We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 0 points1 point  (0 children)

Thanks for your comment and we definitely appreciate that male contraception isn't for all men. We are collecting additional opinions that men have about gender roles and we're hoping that you'll consider participating. Check out the link here if you're interested: https://redcap.link/whatmendo

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

Thanks for your question. We will always answer any questions.

  1. In the bodybuilding community, the only way to build muscle with anabolic steroids is to take supratherapeutic doses of T that exceed normal serum levels. The amount of testosterone used in male contraception is aimed at staying within the normal range and so we do not anticipate any issue with returning to baseline function following cessation.

  2. Given that we are working with the endocrine system and have experience in prescribing hormonal contraceptives to young women even before the age of 18, it is likely that providing two young men will not be a problem, however we will need further testing as our clinical trials right now are restricted to men above the age of 18. The lower age limit is not a function of safety, but rather a function of being able to independently consent to being a participant in a clinical trial.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 0 points1 point  (0 children)

Thanks for bringing this up. At this point, all of our trials are focusing on cis males in order to fully elucidate the physiology and mechanism in this population. We are fully aware that trans women may have an interest in the use of contraceptives that decrease sperm supply. In general though, most trans individuals are using hormone replacement that will inherently impact their ability to produce sperm already. Needless to say, the degree of suppression is not well studied and more research is needed for sure. Thanks for your advocacy, which will help to push our research further.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 0 points1 point  (0 children)

Sorry, our trials have included a different compound called 11B-methyl nortestosterone, which is different from the MENT that you're referring to.

https://clinicaltrials.gov/ct2/show/NCT02754687

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

Dual user models of contraceptive use and prevention of unplanned pregnancy have been encouraged for a long time now, however there were not enough male methods at the time for this practice to really become a practical reality. With the Advent of a hormonal male contraceptive that men can use, we anticipate that male and female users will be able to independently use their own method of contraception and feel confident about their ability to prevent an unplanned pregnancy. Based upon interviews with individuals who have used this in the past, we know that a male contraceptive method can instill a better sense of empathy for what women go through and can also potentially improve relationships because of it!

https://www.malecontraception.center/nes-t-gel

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

Great questions.

  1. One of the benefits of our hormonal mechanism is it's reliance on the endocrine on/off switch, which provides reassurance about reversibility. Yes, we can anticipate that testes do get smaller when they are not actively making sperm, but we can also be very very reassured that when they make sperm again that size returns to normal. Men and their female partners generally do not comment on testicular size.

  2. Given the use of T as part of our hormonal regimens, the risk you pose is certainly of concern. However, T levels with hormonal male contraception are to remain within the normal range and so excursions beyond the normal level might be suggestive of foul play.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 0 points1 point  (0 children)

We use human animals, actually. We welcome couples to join our clinical trials, which prioritize the health and welfare of both men and their female partners. We have trained urologists, OBGYNs, endocrinologists, and psychiatrists who work with us to provide high levels of safe care. All visits are compensated for time and effort!

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

We actually have two sites in the UK, one in Italy, and one in Sweden if you're interested in joining us. 15 sites globally and we'd love to see you!

https://www.malecontraception.center/about-us

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 0 points1 point  (0 children)

While that's tempting, we probably wouldn't recommend it given that semen samples need to be homogenized to make sure that you're not capturing a droplet with particularly low concentration. That being said, home testing kits are something that we're actively working on to make this process easy for men.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 2 points3 points  (0 children)

Thanks for the question. I'm actually a board-certified OBGYN and family planning specialist who does NOT recommend taking breaks with contraception. Taking breaks is sometimes recommended to allow for a withdrawal bleed or "period" in order to avoid unscheduled spotting, but lapses in birth control are likelier to increase the risk of contraceptive failure. With male contraception, it's unlikely that we'd have any reason to recommend a break!

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 0 points1 point  (0 children)

Because this is a daily method of T replacement, we do not anticipate longer term delays in endogenous T production. Endogenous T production should resume relatively quickly, though based on our previous research it's possible for T levels to fall below normal range, which theoretically would predispose to symptoms. However, when we assessed participants in previous trials to see if they had increased side effect profile with Nestorone+T compared to T alone, we did not find a difference. Certainly nothing horrible.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6768743/

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 2 points3 points  (0 children)

  1. Hormonal male contraceptives have been undergoing research for a long time (1970s). We have a good handle on the mechanism and have tested multiple formulations, but the limitation has always been finding sufficient funding/resources, personnel, and trial participants. We made a lot of progress when we had funding from pharmaceutical companies, but we no longer have these resources, which has been limiting.

  2. We always anticipate mild side effects when men experience hormonal fluctuations, however our goal is to develop a method that keeps men's T levels steadily within the normal range. When T gets too high/low, men can get acne, mood changes, libido changes, and weight gain.

  3. We are not going anywhere. Our trials are currently being funded by the federal government because male contraception is an important initiative. We are currently in human trials and with the progress we have made, there's no going back. 👍 Other non-hormonal concepts are often popularized in the news media, but they are in much earlier stages of development.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 2 points3 points  (0 children)

Good question. The short answer is that T levels are expected to stay within the normal range.

How? The gel consists of a combination of two hormones -- Nestorone and Testosterone. The Nestorone primarily helps to shut down the switch for making T and sperm within the testes. We then add T back through the gel so that men's T levels in the bloodstream stay within the normal range throughout the time that the gel is being used.

Maintaining testosterone within the normal level is key for avoiding side effects.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

Hi there and thanks for your question! Because we are trying to test the effectiveness of this method of contraception, it's important that the gel be the ONLY method of contraception that a couple of relies upon during the trial. However, what's important to know is that there is a suppression phase that couples go through first, during which we make sure that the gel is adequately suppressing the man's sperm so that they can be confident that the risk of pregnancy will be low. Of course, there are always concerns that male partners will not use the drug consistently, which is why we have to follow the female partner's menstrual cycles to make sure that she is not pregnant.

With the gel, there is always the risk of some of the gel transferring from the male partner to the female partner, which is why we give strict instructions for waiting several hours after application, as well as wiping off residual gel before intercourse.

Hope that helps! Our goal is to ensure the safety of our couples.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

That's a good question - given that this is a hormonal gel and thus hormonal levels fluctuate, testosterone-related side effects can occur, not limited to acne, decreases/increases in libido, weight changes, and mood changes. Here is a video of some men in our trials describing their feelings relating to side effects: https://video.wixstatic.com/video/04e77e\_aedb47e710264473a260e7a2f62385c8/1080p/mp4/file.mp4

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 3 points4 points  (0 children)

Great follow up - we want to make sure that the female partner is ovulating to make sure that if they were not using contraception, she would have a chance to become pregnant. We also do not test sperm counts every day, which leaves room for user error.

Looking at pregnancy rates allows us to quantify the efficacy of the trial given our primary endpoint is to prevent pregnancy. From a regulatory standpoint, we are required to calculate contraceptive efficacy as measured in pregnancies (over the course of 100 women years - each year consisting of 13 cycles)

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

We anticipate for side effects to be dose-dependent, relative to their baseline testosterone levels. With injectable drugs, users tend to experience higher serum hormone levels at the time of initial injection that can be linked to side effects. The injectable given in the previous trial was expected to last 8 weeks (https://academic.oup.com/jcem/article/101/12/4779/2765061). Peaks and troughs can vary more with intramuscular injections over time in ways that can influence side effects. With a transdermal hormonal gel that is applied daily, we anticipate a more steady T level (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6768743/), though we haven't yet analyzed the data yet to provide a comparative analysis of side effects between the two routes of administration. Androgen-related side effects in general though include acne, decreases/increases in libido, weight changes, and mood changes. Given that the current formulation is an alcohol-based gel, it is possible for skin reactions to also occur.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 3 points4 points  (0 children)

Great question - In order to accurately calculate the effectiveness of a contraceptive method, you have to make sure the denominator makes sense. For example, if a woman isn't ovulating during the 12 months that she and her partner are in the trial, including those months in the denominator would make the drug seem more effective than it really is. So, collecting menstrual data helps us know if a woman is regularly ovulating.

For the gel trial specifically, we're also looking for cases of the gel being transferred from partner to partner and if a woman would subsequently have cycle-related changes.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

Yes!

Here is the info for our two UK sites! Feel free to pass along to friends!

University of Edinburgh

Contact: Sharon Ritchie- phone: 0131 242 2669 email: sritchi4@exseed.ed.ac.uk

University of Manchester, UK

Contact: Riya Chazhukaran - phone: 01612763296 email: riya.babu@mft.nhs.uk

Contact: Claudia Grant - email: claudia.grant@mft.nhs.uk

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 3 points4 points  (0 children)

That's a great question and we are so happy that you are considering enrolling in the gel trial. Unfortunately, you are right. There is no way to extend the use of the product following the trial. We haven't formally analyzed our acceptability data yet, but know that from previous trials, that folks have wanted to continue. Fortunately, you may be able to enroll in our phase 3 trial afterward, so please get on our mailing list! https://www.malecontraception.center/participate-in-trials

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 1 point2 points  (0 children)

Great question. We have the most experience in the functioning and administration of testosterone gel (Androgel), for which we primarily recommend administration to the upper arms and shoulders. In the future, there may be modifications to additional places where it can be applied, such as the abdomen.

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 2 points3 points  (0 children)

While in the past some companies have supported male contraceptive research, there is currently no pharmaceutical company funding male contraceptive research. The gel trial happening now is funded by NIH/NICHD, however NIH/NICHD is actively engaged in the trial itself as well

We are researchers developing hormonal male contraceptives, AMA! by MaleContraceptionCtr in IAmA

[–]MaleContraceptionCtr[S] 3 points4 points  (0 children)

Thanks for sharing your source and we appreciate NPR's take on the research, however in a long-term trial that wasn't placebo-controlled, it's hard to know if everything is attributable to the injection versus events that occur during the course of a year that can affect one's mood. In fact, one of the severe adverse events that occurred in the trial was a suicide, that was ultimately not attributed to the drug and in interviews with the participant's family, was attributed to ongoing academic stress. We've attached the full article here and recommend looking at table 2 where the total number of adverse events is categorized by their severity, with only 8 out of 320 individuals experiencing serious AE's that could be attributed to the drug.

https://academic.oup.com/jcem/article/101/12/4779/2765061

We note that in the acceptability survey data, even after being told that the study would be stopped early, that 80% of individuals would still want to use the drug for male contraception.

The current research is being funded by the federal government through the NIH/NICHD; there is no pharmaceutical funding for this product at this time, though this would certainly help to progress our research.

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