Tildacerfont for Polycystic Ovary Syndrome

Phase 2

Waitlist Available

Research Sponsored by Spruce Biosciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks (assessed at baseline, weeks 4, 8 and 12)

Summary

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.

Eligible Conditions

Polycystic Ovary Syndrome

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks (assessed at baseline, weeks 4, 8 and 12)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks (assessed at baseline, weeks 4, 8 and 12)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks (assessed at baseline, weeks 4, 8 and 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DHEAS level

Secondary study objectives

Normalization of DHEAS

Number of subjects with TEAE as assessed by CTCAE Version 5

Reduction in DHEAS

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tildacerfont

2022

Completed Phase 2

~30

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