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

Palo Alto (17 mi)

Age: 18 - 65

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Spruce Biosciences

Prior Safety Data

Trial Summary

What is the purpose of this trial?This trial is testing a medication called tildacerfont to help women with PCOS who have high levels of certain hormones. The goal is to see if this medication can safely lower these hormone levels and improve symptoms.

Eligibility Criteria

Treatment Details

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment with TildacerfontExperimental Treatment1 Intervention

Subjects randomized in this arm will receive 4 weeks of 50mg of oral tildacerfont tablet, followed by 4 weeks of 100 mg oral tildacerfont tablet, and then 4 weeks of 200 mg oral tildacerfont tablet for a total of 12 weeks of treatment.

Group II: Placebo Control ArmPlacebo Group1 Intervention

Subjects randomized in this arm will receive 12 weeks of oral matched-placebo tablet