“Whoever comes up with the first male contraceptive, it’s going to be interesting to see how they market it and bring it to market,” says Daniel S. Johnston, PhD, chief of the Contraception Research Branch at the Eunice Kennedy Shriver National Institute of Child Health and Human Development in Bethesda, MD.

Hormonal male contraceptives must overcome the challenge of producing a product that changes the body’s production of testosterone. These products can leave side effects that make them less appealing to men. Researchers have worked for decades to produce hormonal products that can stop sperm production, but reduce side effects.

“All of men’s hormones are tightly linked to sperm production. If you shut down one, you have to give him another,” says Anita L. Nelson, MD, professor and chair of obstetrics and gynecology at Western University of Health Sciences in Pomona, CA.

There are big differences in men’s sensitivity to hormonal contraceptives. “At research sites in China, they had [potential contraceptives] that would bring sperm counts down to zero, while the same [dose] in the U.S. would bring sperm counts to the three-to-five million range,” Nelson explains. “Researchers have to look for a compound to be specific and to not overdose, and to give men a delivery system they will use.”

For instance, injections could work well. “But it’s not reasonable to ask a guy to come in once a week for an injection,” Nelson adds.

Gender Roles Changing

Contraception has been an assigned responsibility for women for a long time, but that is beginning to change, says Logan Nickels, PhD, research director of the Male Contraceptive Initiative in Durham, NC.

“We are understanding that gender roles don’t have to be static over time,” Nickels says. “Men are starting to step up and have the ability to be more a part of these conversations.”

Previously, some men and groups were reticent to infringe on the bodily autonomy and rights of women. But now they understand there is a way they can build mutual understanding and common purpose when it is time to have a family, Nickels explains.

“It’s a process that takes two, and both parties should have some piece of decision-making and have tools to participate in the decision,” he says.

Some new surveys and studies suggest that the time may be right for bringing a male contraceptive to a receptive market.

For example, when the Male Contraceptive Initiative asked men ages 18 to 44 years about male contraception:

• 60% of men said they would like to take responsibility for birth control as a key reason for wanting a new male method;
• 80% said they would prefer a nonhormonal method, while 38% would prefer a hormonal method of male birth control;
• 89% said they wanted a reversible contraceptive method;
• 80% said it is important to have a contraceptive method that also protects against sexually transmitted infections.¹

“Another area we’re focused on understanding is the desires of young people,” says Heather Vahdat, MPH, executive director of the Male Contraceptive Initiative. “We assessed whether they would be interested in taking a pill before intercourse rather than taking a pill every day or using gel or an implant. The highest percentage of interest was in taking a pill before intercourse,” Vahdat says. “Everyone thinks, ‘Why should I take a pill every day for something I’m not doing every day?’”

Other research has assessed whether men would find certain types of contraceptive administration acceptable. For example, one study about a daily pill regimen — dimethandrolone undecanoate — found that 80% of participants reported satisfaction with the birth control method, and 77% would recommend it. In the trial, participants were randomized to receive up to four capsules daily vs. placebo. They had to ingest the pills within 30 minutes of eating a high-fat meal. Nine out of 10 male participants said they had no trouble taking the four pills within 30 minutes of the meal.²

Since there are many safe and effective female contraceptives on the market, developing and marketing a male contraceptive has a higher hurdle. This is a development challenge funders are trying to address.

“Our research is trying to make more of an effort to bridge product developers and people who do marketing studies,” Johnston says. “We’re very interested and starting to commit more money — including a workshop this fall — to bring contraceptive product developers together with marketing people. How do you make people want to use these products?”

The National Institutes of Health can fund these early male contraceptive studies, but it will not sell the products, he says.

“We need someone in the industry to come in and invest in it,” Johnston adds.

REFERENCES

1. Male Contraceptive Initiative. Interest among U.S. men for new male contraceptive options: Consumer research study. February 2019. https://www.malecontraceptive.org/uploads/1/3/1/9/131958006/mci_consumerresearchstudy.pdf
2. Nguyen BT, Farrant MT, Anawalt BD, et al. Acceptability of oral dimethandrolone undecanoate in a 28-day placebo-controlled trial of a hormonal male contraceptive prototype. Contraception 2020;102:52-57.

The marathon race for finding an effective and safe male contraceptive has reached a hurdle that was not as much of a barrier for the research race to bring the first female contraceptive to market: Someone needs to prove men want their own contraceptive and will use whatever method succeeds.