Nestorone®/Testosterone Transdermal Gel
for Male Hormonal Contraception
The Population Council developed a contraceptive gel for men that can be applied once daily and is absorbed through the skin of a man’s shoulders and upper arms. The gel contains the progestin Nestorone®, which has been shown to suppress sperm creation in men, and Testosterone (T), which is already approved and marketed in gel form in the United States.
Previous clinical studies through the NICHD indicate that Nestorone®/Testosterone gel reduces sperm production to a level considered to indicate successful sperm suppression while maintaining healthy T levels, and thereby minimizing side effects like low libido, acne, weight gain, and altered cholesterol.
Early research findings show that the Nestorone®/Testosterone gel is well tolerated with no serious adverse events. A Phase 2b study is planned to demonstrate the efficacy, safety, and acceptability of the gel when used by men to prevent pregnancy among couples in seven countries around the world. The trial is expected to enroll approximately 420 couples in 2018, and is sponsored by the NICHD.
"the daily male birth control pill"
Unlike the Nestorone/T gel, DMAU is a single hormone packaged into a single oral pill that men can take daily to suppress their sperm production. DMAU has properties of both an androgen and a progestin. In fact, DMAU has strong binding and activating affinity to the androgen receptor, which means that a little goes a long way in helping to prevent side effects that can happen when decreasing a man's testosterone.
Trials are both recruiting and ongoing in the United States with the goal of finding the most effective and acceptable dose. We are also trialing an injectable form of DMAU.
11β Methyl Nortestosterone Dodecylcarbonate (11β-MNTDC)
"...even more daily male birth control pills!"
The National Institute of Child Health and Human Development has synthesized several other orally, bioactive androgens that, like DMAU, act on both the androgen and progesterone receptors. This means that 11β-MNTDC may be another candidate for use as a daily male birth control pill. While research on this compound is not as far as research on DMAU, multiple human trials have been conducted providing confidence that this drug will be safe. The next step is figuring out the perfect dose for sperm suppression.