Study Stopped
The study was discontinued early by the sponsor
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
1 other identifier
interventional
27
1 country
21
Brief Summary
An investigation of the safety and efficacy of tildacerfont in women with PCOS and elevated adrenal androgens
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2022
Shorter than P25 for phase_2
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 6, 2022
CompletedFirst Posted
Study publicly available on registry
May 11, 2022
CompletedStudy Start
First participant enrolled
May 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedResults Posted
Study results publicly available
October 9, 2025
CompletedOctober 9, 2025
September 1, 2025
1.2 years
May 6, 2022
July 14, 2025
September 19, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in DHEAS
To evaluate the effect of tildacerfont in changing (reducing) DHEAS in subjects with PCOS and elevated adrenal androgens
12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Secondary Outcomes (3)
Reduction in DHEAS
12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Normalization of DHEAS
12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Number of Subjects With TEAE as Assessed by CTCAE Version 5
12 weeks (assessed at Baseline, Weeks 4, 8 and 12)
Study Arms (2)
Treatment with Tildacerfont
EXPERIMENTALSubjects randomized in this arm received 4 weeks of 50 mg 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.
Placebo Control Arm
PLACEBO COMPARATORSubjects randomized in this arm received 12 weeks of oral matched-placebo tablet
Interventions
Oral tablet formulation taken once daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Evidence of:
- History of congenital adrenal hyperplasia (CAH), Cushing's syndrome, pituitary or adrenal disease
- Clinically significant hyperprolactinemia
- Thyroid stimulating hormone (TSH) \<0.1 mU/mL or \>4.5mU/mL at Screening
- Cortisol levels concerning for adrenal insufficiency
- 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
- Females who are pregnant or nursing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (21)
Spruce Study Site
Sacramento, California, 95817, United States
Spruce Study Site
San Francisco, California, 94158, United States
Spruce Study Site
New Haven, Connecticut, 06519, United States
Spruce Study Site
Clearwater, Florida, 33759, United States
Spruce Study Site
Lake Worth, Florida, 33461, United States
Spruce Study Site
Miami, Florida, 33173, United States
Spruce Study Site
Winter Park, Florida, 32792, United States
Spruce Study Site
Idaho Falls, Idaho, 83404, United States
Spruce Study Site
Wichita, Kansas, 67226, United States
Spruce Study Site
Boston, Massachusetts, 02115, United States
Spruce Study Site
Fall River, Massachusetts, 02720, United States
Spruce Study Site
Southfield, Michigan, 48034, United States
Spruce Study Site
Williamsville, New York, 14221, United States
Spruce Study Site
Raleigh, North Carolina, 27612, United States
Spruce Study Site
Cincinnati, Ohio, 45219, United States
Spruce Study Site
Cleveland, Ohio, 44106, United States
Spruce Study Site
Philadelphia, Pennsylvania, 19104, United States
Spruce Study Site
Bedford, Texas, 76022, United States
Spruce Study Site
Houston, Texas, 77024, United States
Spruce Study Site
Houston, Texas, 77030, United States
Spruce Study Site
Morgantown, West Virginia, 26506, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
The study was terminated by the sponsor; therefore, there were a small number of subjects for analysis.
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Spruce Biosciences
Study Officials
- STUDY DIRECTOR
Will Charlton, MD
Spruce Biosciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Masking Details
- Double-blind randomization performed by IRT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 6, 2022
First Posted
May 11, 2022
Study Start
May 15, 2022
Primary Completion
August 3, 2023
Study Completion
August 31, 2023
Last Updated
October 9, 2025
Results First Posted
October 9, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share