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A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens | Clinical Trials | Clareo Health

TERMINATEDPHASE2

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

NCT05370521•Spruce Biosciences

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 40 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•Female subjects aged 18 to 40 years old at Screening visit
•Diagnosis of PCOS (either historical or during Screening) according to NIH (1990) criteria
•DHEAS level \> age-matched upper limit of normal (ULN) at Screening visit
•Agree to follow industry standard contraception guidelines within protocol

Exclusion Criteria

•Evidence of:
•1. History of congenital adrenal hyperplasia (CAH), Cushing's syndrome, pituitary or adrenal disease
•2. Clinically significant hyperprolactinemia
•3. Thyroid stimulating hormone (TSH) \<0.1 mU/mL or \>4.5mU/mL at Screening
•4. Cortisol levels concerning for adrenal insufficiency
•5. Other findings suggestive of secondary cause for anovulation and/or hyperandrogenemia
•Total testosterone levels \>140 ng/dL, DHEAS \>650 mcg/dL, virilization or other signs or symptoms concerning for ovarian hyperthecosis or androgen-secreting tumors
•Medical conditions that require glucocorticoid treatment within 30 days of screening and throughout the duration of the study
•Clinically significant unstable medical conditions, illness, or chronic diseases
•Prior hysterectomy or bilateral oophorectomy
+1 more criteria

Locations (21)

Spruce Study Site

Sacramento, California, United States

Spruce Study Site

San Francisco, California, United States

Spruce Study Site

New Haven, Connecticut, United States

Spruce Study Site

Clearwater, Florida, United States

Spruce Study Site

Lake Worth, Florida, United States

Spruce Study Site

Miami, Florida, United States

Spruce Study Site

Winter Park, Florida, United States

Spruce Study Site

Idaho Falls, Idaho, United States

Spruce Study Site

Wichita, Kansas, United States

Spruce Study Site

Boston, Massachusetts, United States

Key Dates

Start Date

May 15, 2022

Primary Completion Date

August 3, 2023

Completion Date

August 31, 2023

Last Updated

October 9, 2025

Enrollment

ACTUAL participants

Conditions

Polycystic Ovary Syndrome

Interventions

Tildacerfont

DRUG

Placebo

DRUG

Glucose Profiles in Women With Polycystic Ovary Syndrome

NCT07483723

Polycystic Ovary SyndromeGlucose Profile+2 more

View study

RECRUITING

Pro- and Anti-inflammatory Cytokines in PCOS

NCT06793085

Reproductive AgePCOS (Polycystic Ovary Syndrome)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Glucose Profiles in Women With Polycystic Ovary Syndrome

Pro- and Anti-inflammatory Cytokines in PCOS

Functional Proteins in Polycystic Ovary Syndrome

Multidisciplinary Diagnosis and Treatment of Polycystic Ovary Syndrome

Evaluation of the Effect of Time-Restricted Feeding and Mediterranean Diet Model in Women With Polycystic Ovary Syndrome

Treatment of Menstrual Cycle Alterations in Adolescents