Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Spruce Biosciences
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.
Age
18–40
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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 be if
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
