NCT05370521

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Spruce Biosciences · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Polycystic Ovary Syndrome

Interventions

Type	Name	Description
DRUG	Tildacerfont	Oral tablet formulation taken once daily.
DRUG	Placebo	Non-active dosage form taken once daily.

Timeline

• Start date: 2022-05-15
• Primary completion: 2023-08-03
• Completion: 2023-08-31
• First posted: 2022-05-11
• Last updated: 2025-10-09
• Results posted: 2025-10-09

Locations

21 sites across 1 country: United States

Regulatory

• FDA-regulated drug study