New Study Reveals Male Birth Control Gel May Soon Be A Reality

“Male birth control aims to temporarily reduce or halt the production of sperm, thereby preventing fertilization [of an egg] during sexual intercourse,” says Justin Houman, M.D., a board-certified urologist, men’s health specialist and Forbes Health Advisory Board member based in Los Angeles.

Current male birth control methods include abstinence, condoms and vasectomies. Vasectomies, which involve cutting and sealing the vas deferens (tubes that carry sperm from the testicles to the urethra), have risen in popularity, with rates of the procedure increasing 26% over the last decade, according to the American Medical Association^[2]What doctors wish patients knew about getting a vasectomy. American Medical Association. Accessed 6/12/2024. . However, the procedure is typically permanent and reversals aren’t always possible.

Access to safe, effective and reversible birth control for men is an “unmet need,” researchers note in the Endocrine Society press release. While some studies have shown that certain hormones may offer effective birth control for men, these methods are limited by how slowly they suppress sperm production, according to researchers in the press release.

There are several new male birth control methods under investigation, says Dr. Houman, including hormonal and non-hormonal options. “Hormonal methods often involve the use of testosterone and progestin [a synthetic form of the naturally-occurring hormone progesterone, which supports the menstrual cycle and pregnancy] to suppress the production of sperm in the testes. These hormones trick the body into thinking it has enough testosterone, thereby reducing the signals that stimulate sperm production,” he explains. “Non-hormonal methods include the use of drugs that interfere with sperm maturation or motility and physical methods like vas-occlusion, which temporarily block the vas deferens,” adds Dr. Houman.

Proposed hormonal male birth control methods such as pills, injectables and topical gels could help prevent pregnancy by lowering sperm counts. The new male birth control gel that is currently being studied, for example, uses a combination of the hormones testosterone and segesterone acetate to suppress sperm production. Meanwhile, an injectable male birth control dimethandrolone undecanoate (DMAU), which is also undergoing clinical trials to determine its safety and efficacy, combines the hormones testosterone and progestin to suppress sperm production.

The clinical trial assessing the efficacy of the topical male birth control gel examined 222 men who underwent at least three weeks of daily treatment. Applied once daily to each shoulder, the birth control gel contains 8 milligrams of segesterone acetate and 74 milligrams of testosterone.

While testosterone treatment alone can suppress sperm count, the inclusion of segesterone acetate quickens the suppression time, which helps this gel curb sperm production at a faster rate than other experimental, hormone-based male birth control methods, according to the press release. Segesterone acetate also lowers the amount of testosterone needed to suppress sperm count, keeping testosterone levels within a healthy range and allowing users to maintain normal sexual function.

Researchers measured sperm suppression by performing sperm counts at four-week intervals. A majority of participants (86%) reached the target sperm count by week 15, according to researchers. What’s more, the study found that this treatment effectively lowered sperm counts by week eight—faster than prior studies on injectable male contraception methods, which took nine to 15 weeks to lower sperm counts.

For the birth control gel to be considered effective, participants’ sperm count must contain 1 million or fewer sperm per milliliter of semen.

Segesterone acetate isn’t active when taken orally but is highly effective when applied to the skin, according to research. Additionally, this hormone doesn’t bind to androgen (sex hormones that give men “male” characteristics) or estrogen receptors, meaning it’s less likely to cause undesirable side effects like minor mood changes, acne and gastrointestinal symptoms.

“The results of the clinical trial demonstrating that a contraceptive gel can effectively lower sperm counts are promising,” says Dr. Houman. “For the future of birth control, this means we may soon have a viable, non-permanent contraceptive option for men, adding to the existing choices and sharing the responsibility of contraception more equitably between genders,” he adds.

Future studies on the segesterone-testosterone birth control gel will test its effectiveness, safety, acceptability and reversibility after treatment. The U.S. Food and Drug Administration (FDA) must approve and clear the contraceptive as both safe and effective for it to become available to consumers.

“This trial is a phase 2B trial, which means that there are enough participants to confirm that the drug is safe and effective, but [these findings] need to be confirmed by an additional phase 3 trial,” explains Kelly Culwell, M.D., a board-certified OB-GYN and Forbes Health Advisory Board member. “Getting through a phase 3 trial and to FDA approval could still be five or more years away,” she adds. “However, this [trial] is a very important step in demonstrating that hormonal contraception for men could be available in the near future.”

Like most clinical trials, phase 3 of this trial will examine 300 to 3,000 participants over one to four years. If research indicates the contraception is safe and effective, it will move onto phase 4 of clinical research, during which the FDA review team will examine the existing research and decide whether to approve the birth control gel. If approved, manufacturers will work with the FDA to develop prescribing information that describes how to best use the medication.

While widespread access to male birth control may still be years away, results from this specific phase 2 trial suggest that access to effective and reversible contraception for men could become a reality for many.