Innovations in male contraceptives have the potential to change the world of family planning in significant ways. This interview by FHI 360’s Stevie O. Daniels with Heather Vahdat, MPH, executive director of the Male Contraceptive Initiative (MCI), provides a deeper look. With more than a decade of experience in contraceptive development, Vahdat spoke with us about how new male contraceptives will shape global public health outcomes. She develops programs to impact male contraceptive innovations, including research, development, and advocacy. MCI, a nonprofit organization based in Durham, North Carolina, USA, was founded in 2014 to provide research and advocacy support for the development of new methods of nonhormonal, reversible male contraceptives.
Heather’s Answer: There is a spectrum of development ranging from early-stage to almost ready for clinical trials. One of the products nearest to market is a “set it and forget it” method—like an IUD for women. It is an injection that places a polymer-based, porous plug into the vas deferens to block sperm from leaving the body. The method is reversible, either by a degradation of the plug over time or via a second injection. One of the companies working on this kind of product, Contraline, expects to start a first-in-human study this year.
Some other male contraceptive innovations under development will move into clinical trials in a year or two. Products in the earliest stages are those for which compounds or molecules that could eventually constitute a drug are just being identified or optimized. The field has moved slowly as there is limited funding for male contraceptive research, which is why MCI focuses on nonhormonal methods.
A: The product I just described is, at best, five years away from being on the shelves. The others could be 10 to 20 years away. Again, that is from our perspective supporting nonhormonal method development. Male hormonal contraceptive products are a bit further along. For instance, there is a large clinical trial of a hormonal gel underway with support from the National Institutes of Health. This study started in 2018 and includes sites across the United States, Chile, Italy, Kenya, Sweden, and the United Kingdom. If those studies are successful, a hormonal product could be available in less than ten years.
A: Yes!! Some very cool work using hydrogels is being done by Eudaemon Technologies of New South Wales. They call the product Geldom. It is a traditional condom that they describe as soft, squishy, stretchy, and slippery. So, it feels more like tissue than rubber. They expected to begin a human trial by the end of 2018 and have the product on the market two years later.
Condoms will always be important and fundamental in the realm of contraception because they are currently the only contraceptive method that also provides protection from sexually transmitted infections.
A: Nonhormonal methods have specific molecular targets rather than being based on hormones that can affect other functions in the body. The reason this approach is possible in men is because sperm cells are distinct from all other human cells—they have unique characteristics so they can be targeted for modification without impacting characteristics and functions that might be shared with other cells.
There is already good work being done in the hormonal space, so we believe that focusing on nonhormonal male contraception innovations is where we can have the greatest impact.
“Development of these products will finally address the needs of 50 percent of the global population who have not had a wide range of contraceptive choices.”
A: Opportunities! Development of these products will finally address the needs of 50 percent of the global population who have not had a wide range of contraceptive choices. Providing men with more choices helps fill the unmet need for contraception around the world… it is helpful not only for men but also women. With more resources, men can contribute equally to family planning goals.
A: Increasing contraceptive choices for men will disrupt the field in every way—including shifting the idea that contraception is just for women and bringing men along as partners in preventing pregnancy. Nearly 50 percent of pregnancies are unintended. A wider choice of male contraceptives can change behavior related to this situation. It will take more of the political aspects out of family planning and disrupt the market. Social, economic, and individual relationships will be changed when men have more contraceptive choices.
“Nearly 50 percent of pregnancies are unintended. A wider choice of male contraceptives can change behavior related to this situation.”
A: Fifty percent of the global population is male; we know a wider set of options is needed. Even so, people keep saying they want proof that there’s a market for male contraceptives. We did a consumer research study that found an estimated 17 million men are looking for more contraceptive options in the United States. And, a new study in The Netherlands showed the majority of young adults believe there should be more contraceptives for men.
Another public perception to overcome is that men won’t use them, and women won’t trust them to use them. We have to get past that dismissive attitude. Research has shown the unmet need for contraception among women in general; so, providing men with more options will help meet women’s needs, too.
Advocacy and outreach are key, as well. When I mention male contraceptives to people in passing, I often get a response “oh, I never heard about that, really?” Promotion is important to get people past the “oh” moment—get information out early so people become aware of and support methods in development. We engage youth in our work as interns and through our youth advisory board. They inform their peers, and the circle of awareness expands.
Advocacy and outreach are the heart of MCI. We promote products being developed so more people are aware of the possibilities or that support is needed.
A: Yes. Bringing men into the conversation about contraceptives is important. We did a small study in Oakland, California, with focus group discussions with young people. One male high school student said: “I wish there was something I could take that would protect me.” In the Netherlands study, 87 percent said that a couple should share the responsibility to avoid an unplanned pregnancy and one male respondent said: “A contraceptive for men would give me an extra sense of security. I would be my own boss.”
A: Listening to them. Most men we’ve talked to feel this responsibility already, and not just in the United States. A significant leap will occur in the next generation of men wanting to take responsibility… men who say I don’t want a child right now and I want a method that assures me and my partner that “we” won’t get pregnant.
Men who feel the responsibility falls to women may have the perspective that their own needs are met. There are fewer men in this group, and they probably won’t be the early up-takers of new methods. However, introducing more contraceptive choices will likely impact their view and, possibly, their practice.
A: It is important to talk to them about condoms, but also about what new methods are coming. Explain to them the methods available now and how to use them effectively but also tell them what the future holds so they are prepared to talk to their own children and may talk to their friends about the new methods as well.
A: MCI uses two main mechanisms: grants and program-related investment or “PRI.” Grants are always first priority. They support contraceptive development programs to navigate hurdles necessary to prove efficacy and safety prior to preclinical activities as well as for trials. Few investors put money into this discovery phase. Grants are also given for internships, fellowships, and travel to offer young researchers opportunities for career development.
Program-related investments are our newest mechanism. In our case, this means we offer funds to a company to support more mature research activities. If the product is not successful, the recipient is not required to return any of the investment; but, if they are successful, and as the product achieves profitability, the full investment plus some “up-side” comes back to MCI for reinvestment in more research. This is a critical first step in realizing the concept of team science that MCI champions. Successful groups contribute back to their colleagues to keep the pipeline of products moving and growing.
A: It is different because it means MCI takes the risk at the earliest stage of research. It is important because so few companies will invest at that stage. When a product is successful, MCI benefits later. The company not only benefits from having the funds, but also helps raise money from other sources.
In November, we announced our $1 million investment in Contraline, Inc., a medical device company based in Charlottesville, Virginia, for a first-in-human clinical trial of their novel vas-occlusive contraceptive device, ADAM. It is an injectable hydrogel that offers a long-lasting implantable contraceptive for men. It is inserted into the vas deferens through a quick and minimally invasive outpatient procedure using local anesthesia. The hydrogel blocks the flow of sperm without affecting sensation or ejaculation.