A hormone-free male birth control pill passed its first safety test in ongoing clinical trials, marking a major milestone in its development.
The results from the early phase 1 clinical trial testing the safety of the daily pill referred to as YCT-529 were published on Tuesday in the journal Communications Medicine.
The pill is designed to decrease sperm count by impairing retinoic acid signaling in the testes, according to its San Francisco-based developers YourChoice Therapeutics.
RELATED STORY | Male birth control gel shows promising results in clinical trials
The early clinical trial included 16 male volunteers aged 32 to 59, all of whom had undergone a vasectomy. The reason a vasectomy was a requirement for the trial is that the developers wanted the extra precaution to avoid the risk of permanently affecting participants’ fertility, since the drug has not been clinically trialed for effectiveness — just safety.
The volunteers were each given single oral doses of 10mg, 30mg, 90mg or 180mg of YCT-529 after fasting. The participants' reaction to the medication was studied for safety and potential side effects on heart rate, inflammatory biomarkers, sexual desire and mood.
They also received a 30mg dose after eating to study the effects of the drug mixed with food.
The trial did not assess the pill’s efficacy in reducing sperm, but those trials are ongoing.
Researchers said the study did not find any adverse effects from the drug, signaling promise as it continues its development.
