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A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens

Polycystic Ovary Syndrome Clinical Trial

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

Clinical Trial Summary

An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens

Clinical Trial Description

This is 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 will be randomized 2:1 (tildacerfont:placebo) at baseline. The study will consist of 3 consecutive 4-week treatment periods at each dose level. Duration of participation is approximately 25 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05370521
Study type Interventional
Source Spruce Biosciences
Contact
Status Completed
Phase Phase 2
Start date May 15, 2022
Completion date August 31, 2023
View Details
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