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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Spruce Biosciences

Criteria

Inclusion Criteria:

• Female subjects aged 18 to 40 years old at Screening visit

• Body Mass Index (BMI) =/< 38 kg/m2 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:

• Hemoglobin A1C (HbA1C) >/= 6.5% at screening or diagnosis of diabetes

• 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

• Females who are pregnant or nursing