Sunday, July 27, 2025

First Hormone-Free Male Birth Control Pill Shown Safe and well tolerated in first Human Trial

Good news! Sixteen males so far have tested this new pill!

How many more years will it take to become available?

Here is my previous blog post on this pill!

"... In the first clinical trial of its kind, a non hormonal oral contraceptive that reversibly stops sperm production has just been deemed safe for human use. The daily pill, called YCT-529, blocks a vitamin A metabolite from binding to its receptor in the testes; this prevents the chain of gene-expression changes that are required to start the sperm-making process. Safety results from the early phase 1 clinical trial were published on Tuesday in Communications Medicine.

The trial did not assess the pill’s efficacy in reducing sperm, and the drug’s developer, YourChoice Therapeutics, is currently running trials to collect that data. ..."

From the abstract:
"Background
Since nearly half of all pregnancies in the US and worldwide are unintended, there is a critical need for additional contraceptive options for men and women. After a hiatus in non-hormonal male contraceptive development of about half a century, the new chemical entity YCT-529 – a retinoic acid receptor-α antagonist - is being developed as a non-hormonal oral male contraceptive to decrease sperm count by impairing retinoic acid signaling in the testes.

Methods
Here, we report the results of the first in human Phase 1a clinical trial with YCT-529 to assess its safety, tolerability, pharmacokinetics and pharmacodynamics, and its potential effects on heart rate, inflammatory biomarkers, sexual desire and mood
Sixteen male volunteers were enrolled to receive single oral doses of 10, 30, 90 or 180 mg of YCT-529 in the fasted state. Volunteers also received 30 mg in the fed state to study the effect of food on the pharmacokinetics of YCT-529.

Results
Single doses of up to 180 mg of YCT-529 had no effects on heart rate, hormone (follicle-stimulating hormone, luteinizing hormone, and testosterone), sex hormone-binding globulin or inflammatory biomarker levels, sexual desire or mood. Further, there was no clear food effect on the pharmacokinetics of YCT-529.

Conclusions
Overall, YCT-529 was well tolerated in this single ascending dose study (ClinicalTrials.gov registration: NCT06094283), which is a substantial requirement in contraceptive development."

Hormone-Free Male Birth Control Pill Shown Safe in Human Trial - Human Progress

First Hormone-Free Male Birth Control Pill Shown Safe in Early Human Trial "A hormone-free pill, called YCT-529, that temporarily stops sperm production by blocking a vitamin A metabolite has just concluded its first safety trial in humans, getting a step closer to increasing male contraceptive options"



Fig. 1: Phase 1a study design.


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