Hormonal Male Birth Control Product Reaches Late-Phase Clinical Trials

The only male forms of birth control currently available are condoms and vasectomies. With a limited choice in male birth control, contraception typically falls on the child-bearing individual. This milestone development of hormonal male birth control potentially reaching phase III clinical trials may indicate a new era of contraceptives.

According to the CDC, approximately 45% of pregnancies in the United States are unplanned, disproportionately affecting people of color and lower socioeconomic backgrounds.

“An unintended pregnancy is a risk factor for poor maternal mental health, including perinatal depression, stress, and lower levels of psychological well-being and life satisfaction. An unintended pregnancy increases the risk of maternal depression and parenting stress,” stated researchers in a BMC article.

The NICHD spotlight outlines the current success of the clinical trial on NES/T (Nestorone/Testosterone), a transdermal male contraceptive gel. It is applied on the shoulder blades to inhibit sperm production.

Currently, this trial is in phase IIb. The gel contains Nestorone, which lowers sperm production from 15 to 200 million sperm per milliliter to less than 1 million sperm per milliliter. Synthetic testosterone is also added to the gel to maintain sex drive and function.

Based on data from the spotlight, “Nestorone alone would not make a great male contraceptive because inhibiting testosterone production in the testes also lowers testosterone in the blood, which would reduce libido, sexual function, and other testosterone-dependent activities.”

Individually, the two components of this product have been approved and widely used. Nestorone also inhibits ovulation and is currently used in the hormonal vaginal ring. Today, many men already use gels containing synthetic testosterone as a hormone replacement, such as Androgel and Testin.

“The results have been much better than we expected, and we’re very excited. The efficacy rate appears better than ‘the pill’ and, so far, seems on par with long-acting reversible contraceptives for women,” said Diana Blithe, PhD, chief of NICHD’s Contraceptive Development Program, in the spotlight.

As the clinical trials progress, providers and patients will await these results. Adding another male birth control option may help minimize the risk of unintending pregnancy. Additionally, as the climate surrounding contraception remains unsteady due to political changes, an increase in family planning options and accessibility may provide comfort to anyone able to get pregnant.