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

NCT05370521 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-10-09

Study results available
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Summary

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

Conditions

  • Polycystic Ovary Syndrome

Interventions

DRUG

Tildacerfont

Oral tablet formulation taken once daily.

DRUG

Placebo

Non-active dosage form taken once daily.

Sponsors & Collaborators

  • Spruce Biosciences

    lead INDUSTRY

Principal Investigators

  • Will Charlton, MD · Spruce Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-15
Primary Completion
2023-08-03
Completion
2023-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05370521 on ClinicalTrials.gov