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Corticosteroid
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
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)
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
Who is running the clinical trial?
Spruce BiosciencesLead Sponsor
5 Previous Clinical Trials
278 Total Patients Enrolled
Will Charlton, MDStudy DirectorSpruce Biosciences
6 Previous Clinical Trials
676 Total Patients Enrolled