In a Phase 2 trial, a drug is tested for both efficacy and safety in hundreds of volunteers. There was a previous Phase 2 trial of a contraceptive for men that was stopped because it had too many side effects. The World Health Organization supported its development.
Weight gain and mood issues are possible for the gel trial. Creinin says that there will be a small percentage of men who will have some kind of side effects. The product that is going to work well for the majority of people isn't what we're looking for.
Thousands of couples will likely be included in a Phase 3 clinical trial of the gel. Since the Population Council doesn't have the ability to commercialise drugs, it will need a pharmaceutical company to make it. Early-stage trials of pills designed to lower sperm count are being sponsored by the National Institute of Health.
Financing has been a major hurdle for male contraceptives. The public sector has been the main funders of such efforts.
Rhia Ventures is a San Francisco-based company that is focused on reproductive health. It is important that contraceptives are available for men. Ensuring that there is a robust offering of contraception and access to contraception is going to be important in this post-roe world. The responsibility for pregnancy prevention has been placed on women's shoulders for so long that we are trying to make sure there are more options on the market.
In addition to funding female contraceptive efforts, her firm is investing in a company that is developing a male contraceptive. The vas deferens are the tubes in the male reproductive system that carry sperm. The gel doesn't affect sensation or ejaculation. The approach is being tested in Australia to see if it's safe.
Nonhormonal forms of male contraception are being pursued. Your Choice is working on a pill that blocks sperm cell development, while Eppin is working on a method that stops sperm from fertilize an egg. They haven't moved into human testing.
Getting regulatory approval for any product that clears Phase 3 trials will be one of the hurdles. The FDA will have to decide what level of risk is acceptable because no contraceptive drug for men has ever gotten to that stage. Birth control pills result in about one death per 200,000 users, mostly from blood clot issues. Calculating risk-benefit calculation will be difficult because men don't have any physical risks of pregnancy. That is one reason why pharmaceutical companies are reluctant to get involved in male birth control. He believes that more contraceptive options will benefit everyone.
Creinin wants the government to increase funding for male contraception research. He says that society is on the verge of change. Any product that is first to market is going to be a game-changer.