MalecontraceptionLA

For full disclosure, regarding the gentleman who reported increased libido - I've been working on the manuscript for the past month and so have stared at the results for hours on end. It turns out that the subject who reported increased libido was in the placebo group - so it was a placebo effect.

In all of our trials, we are very cautious about changes in the prostate. In the hormonal contraceptive gel, previous studies (2012, Ilani) showed that there were no changes in serum PSA and a survey of prostate symptoms (IPSS) did not change, which is reassuring.

Regarding a decrease in testosterone, we are actually trying to maintain normal levels - these men are receiving either testosterone or another androgen, in order to maintain all functions including libido.

The most promising study of a hormonal male contraceptive at this point is a male contraceptive gel that contains an androgen plus a progestin (testosterone + Nestorone), which is undergoing a Phase IIb efficacy trial to be started in a couple of months.

Even if the trial succeeds, there are still several hurdles from a production standpoint that might delay FDA approval. Realistically, our best estimate would be not until 2030. Nonhormonal methods face similar barriers. What will speed this up is industry partnership and funding.

Put simply, it works. Preparations that have been studied have been shown to suppress spermatogenesis to levels that make men infertile (< 1 million/mL).

Side effects including changes in libido, changes in mood, and changes in body composition have been reported, but 1) they are uncommon, and 2) a dose finding trial of the male contraceptive gel has been conducted and with the current dose that is to undergo Phase II testing, we are not expecting significant side effects. That being said, every person is different, and their body may react differently, which is the exact same situation for women on hormonal contraception. This is why we are advocating studies on multiple different methods, to fit the needs of different populations.

Great question! In answer to your first question, the adoption of male birth control is really dependent upon the culture of men's engagement in reproductive health, which seems to be changing. A decade ago, men wouldn't even talk about male birth control, let alone what they think about preventing an unplanned pregnancy. Now, you'll hear all sorts of stories about men trying to take control of their fertility and "close calls" they've had in the past. With more young people seeking higher education and careers, we're going to see more men wanting ways to maintain their life plans/goals via the use of contraception. Plus, we've had countless men talk to us about how they'd love to STOP using condoms. So, we actually think that the uptake of male birth control could be quite high, but perhaps limited by some of the access issues that women currently face, such as having insurance coverage to pay for their birth control and finding a place to obtain it.