clinical trial · NCT05370521
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
Polycystic Ovary SyndromeTildacerfontPlacebo
brief summary
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
started
May 15, 2022
primary completion
Aug 3, 2023
completion
Aug 31, 2023
last updated
Oct 9, 2025
detailed description
This was a phase 2 study to evaluate the efficacy, safety and tolerability of 3 doses of tildacerfont in approximately 39 women with PCOS and elevated adrenal androgens assessed by elevated DHEAS levels. Subjects were randomized 2:1 (tildacerfont:placebo) at baseline. The study consisted of 3 consecutive 4-week treatment periods at each dose level. Duration of participation was approximately 25 weeks.
official title
A Randomized, Placebo-Controlled, Dose Escalation Study to Evaluate the Safety and Efficacy of Tildacerfont in Adult Subjects With Polycystic Ovary Syndrome (PCOS) and Elevated Adrenal Androgens
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol