Male birth control pill shows promise in clinical trials

Akash Bakshi, Dr. Gunda Georg, and Dr. Nadja Mannowetz pictured after trial participants took YCT-529 for the first time. 

Results from the first in-human clinical trial of YCT-529, a hormone-free birth control pill for men developed by Dr. Gunda Georg and her team at the College of Pharmacy and YourChoice Therapeutics, showed that the contraceptive was well tolerated. 

“When we first reported this [project], there was a huge storm of excitement and we gave interviews all over the world and that was just the beginning. Now this is actually going somewhere— it passed that first big hurdle,” Georg said. “So, there should be a lot of excitement again— one step closer to the male pill, another major step forward.”

The trial results, published in Communications Medicine, demonstrated that the pill caused no adverse effects in male participants and that hormone levels, mood, and sexual function were all unaffected, according to Dr. Nadja Mannowetz, co-founder, chief scientific officer of YourChoice Therapeutics and first author of the publication. Contraceptive development differs greatly from other drug development due to higher safety requirements, meaning the results checked all the boxes for further development.  

Trial participants remained under observation in the clinic for the following two days after taking the drug for the first time and returned regularly for follow-up visits until 14 days after receiving it. In that time, researchers conducted safety analyses, examining liver and kidney functions, monitoring for any changes in testosterone, and determining drug concentration in the blood. In total, twelve men took the contraceptive and four took placebo pills. 

From there, the team completed a second clinical study demonstrating that a dose of up to 180 milligrams was well tolerated when given for at least 28 days, according to Akash Bakshi, YourChoice Therapeutics co-founder and chief executive officer. That study showed changes in sperm concentration that align with what the researchers were looking for in a product that inhibits retinoic acid receptor alpha, a protein that is instrumental in sperm cell production. Now, the team is working on another clinical study in men to evaluate safety, tolerability and efficacy (impacts on sperm parameters) over a dosing period of 90 days. 

“When we first started working on male contraception, people believed that this drug would never move forward because the safety bar for a male contraceptive is so high,” Bakshi said. “What we keep showing study after study is that the safety profile is quite robust… it seems like men are tolerating the drug well and that there are not any meaningful adverse effects that men are experiencing.”

Georg credits YourChoice Therapeutics for much of the trials’ success, stating that partnership with the small pharmaceutical company moved studies along faster than would be possible with a large company. 

“This is a pioneering study…this could be a winner,” Georg said. “This collaboration has been just incredible.”