Status:
TERMINATED
A Study of Safety and Efficacy of Tildacerfont in Females With Polycystic Ovary Syndrome and Elevated Adrenal Androgens
Lead Sponsor:
Spruce Biosciences
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
PHASE2
Brief 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 leve...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT05370521
Start Date
May 15 2022
End Date
August 31 2023
Last Update
October 9 2025
Active Locations (21)
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1
Spruce Study Site
Sacramento, California, United States, 95817
2
Spruce Study Site
San Francisco, California, United States, 94158
3
Spruce Study Site
New Haven, Connecticut, United States, 06519
4
Spruce Study Site
Clearwater, Florida, United States, 33759