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

  • STATUS
    Not Recruiting
  • participants needed
    39
  • sponsor
    Spruce Biosciences
Updated on 29 September 2023
body mass index
androgens

Summary

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

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.

Details
Condition Polycystic Ovary Syndrome
Treatment Placebo, Tildacerfont
Clinical Study IdentifierNCT05370521
SponsorSpruce Biosciences
Last Modified on29 September 2023

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