A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
NCT ID: NCT05370521
Last Updated: 2025-10-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
27 participants
INTERVENTIONAL
2022-05-15
2023-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Treatment with Tildacerfont
Subjects 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.
Tildacerfont
Oral tablet formulation taken once daily.
Placebo Control Arm
Subjects randomized in this arm received 12 weeks of oral matched-placebo tablet
Placebo
Non-active dosage form taken once daily.
Interventions
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Tildacerfont
Oral tablet formulation taken once daily.
Placebo
Non-active dosage form taken once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
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
* Females who are pregnant or nursing
18 Years
40 Years
FEMALE
No
Sponsors
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Spruce Biosciences
INDUSTRY
Responsible Party
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Principal Investigators
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Will Charlton, MD
Role: STUDY_DIRECTOR
Spruce Biosciences
Locations
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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
Spruce Study Site
Fall River, Massachusetts, United States
Spruce Study Site
Southfield, Michigan, United States
Spruce Study Site
Williamsville, New York, United States
Spruce Study Site
Raleigh, North Carolina, United States
Spruce Study Site
Cincinnati, Ohio, United States
Spruce Study Site
Cleveland, Ohio, United States
Spruce Study Site
Philadelphia, Pennsylvania, United States
Spruce Study Site
Bedford, Texas, United States
Spruce Study Site
Houston, Texas, United States
Spruce Study Site
Houston, Texas, United States
Spruce Study Site
Morgantown, West Virginia, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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SPR001-210
Identifier Type: -
Identifier Source: org_study_id
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