Abortion remains a top issue this election cycle. The uncertainty surrounding reproductive rights since the Supreme Court overturned Roe v Wade has led to a sharp increase in vasectomies and tubal ligations, and has also added fuel to the push to create male contraceptives. National Health Reporter Erin Billups looks at where things stand and at the timeline for getting these options to market. 

There is momentum now to expand the options for male birth control beyond condoms and vasectomies.  

L.R. Fox, CEO of NEXT Life Sciences, said they're seeing growing interest in their non-hormonal birth control options for men. “We see an outpouring of support from men,” said Fox. “They see that their partner is either using contraception that's not working for them, or they aren't able to use contraception and they're trying to find solutions.”

The male contraceptives in development would help to balance the responsibility of birth control among both partners. A new shoulder-applied hormonal birth control gel for men, called NES/T, is making waves. 

“I think one of the most powerful things is listening to the voices of the women who participate in this trial; what it means to them to be off a method that they weren't very happy with in the first place,” said Dr. Diana Blithe, Contraceptive Development Program Chief of the National Institutes of Child Health and Development. “In addition to being a men's health issue, it's a women's health issue,” she said.

Dr. Stanton Honig, Chief of Yale University’s Division of Reproductive and Sexual Medicine Chief, said male contraception has been unsuccessful to date for several reasons.

“Historically, men have not taken as active a role in family planning as they probably should,” said Honig.

While previous hormonal birth control clinical trials have shown promise in suppressing sperm creation, they were ultimately abandoned due to side effects. 

“Men can get oily skin, men can get agitated, men can get mental health issues,” said Honig. “If you actually compare it to the number of side effects that women encounter with the pill, it's probably very similar. If the pill came into existence in 2024, I'm not sure that it would be FDA approved.”

It is not just the short term side effects that are a concern.

“It took 20 years for us to kind of be concerned about female contraception and looking at risks of breast cancer and cardiovascular disease. You know, our sense is that there won't be any long term consequences associated with this, but we really don't know,” said Honig.

He is referring to the NES/T contraceptive gel, developed by the NICHD and Population Council. Blithe is one of the lead researchers running the clinical trials and said so far the drug’s efficacy is higher than the pill used by women, with fewer side effects.

The gel is a combination of the synthetic hormone progestin, which shuts down sperm creation and topical natural testosterone gel.

Blithe said the testosterone helps to maintain blood levels at the physiologic normal levels. “It forms a bit of a reservoir in the skin, and it's released gradually throughout the day,” said Blithe. “You don't get the highs and lows that would maybe contribute more to mood swings or things that are side effects you might worry about.”

NES/T phase 2B clinical trials will wrap up in late 2024. Then, the FDA will decide what the guidelines will be for a phase 3 trial. Blithe said, optimistically, it will take at least another five years, likely more, before the NES/T shoulder gel becomes available if trials are successful.

Meanwhile, Fox said the non-hormonal Plan A contraceptive from NEXT Life Sciences may have a shorter trek to approval. 

“It's a simple injection of the hydrogel, which is designed to be bioinactive and inert, it goes into the vas deferens; forms that flexible filter. Sperm simply get blocked, they get reabsorbed naturally back into the body, similar to any type of spermatogenesis,” said Fox.

It is similar to a vasectomy, but without the surgery. Fox said it is much more easily reversed; the hydrogel stays put until you want it removed. “A quick, simple injection of sodium bicarbonate causes it to dissolve and turn into a water-like viscosity. And it just simply flows out of the vas deferens,” said Fox.

In terms of side effects, the main issues surround improper placement of the hydrogel. The vas deferens is a very small duct, so practitioner training will be very important.

Fox says they hope to bring Plan A to market in 2026. 

“It's a medical device, it's a mechanical filter that simply blocks the sperm and it's otherwise inert. You ensure that the side effects are very localized and you can have high confidence going into marketization,” said Fox.

Clinical trials for Plan A are set to begin at the end of 2024, and it will take a few years after that to apply for FDA approval.