Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 1:10 AM
NCT ID:
NCT01428193
Eligibility Criteria:
Inclusion Criteria:
* Girls ages 13 to 17
* Tanner IV or V stage of puberty
* Post-menarche
* Hyperandrogenemic (total testosterone \> 0.4 ng/mL or free testosterone \> 35 pmol/L) with or without hirsutism
* Normal aspartate aminotransferase/alanine aminotransferase (AST/ALT) (AST \< 35 U/L, ALT \< 55 U/L)
* Hemoglobin \> 12 mg/dL or Hematocrit \> 36%
* Normal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
* Sexually active subjects must agree to abstain or use double barrier contraception during the study
* Subjects must agree not to take any other medications during the course of the study without approval by the study investigators
Exclusion Criteria:
* Abnormal screening labs (with the exception of the expected hormonal abnormalities inherent in hyperandrogenemia)
* Elevated AST/ALT (AST \> 35 U/L, ALT \> 55 U/L)
* Hemoglobin \<12 mg/dL or hematocrit \< 36%
* Weight \< 32 kg
* History of liver disease, peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer
* Pregnant or breastfeeding
* On medications known to affect the reproductive axis within 3 months of the study (including oral contraceptive pills, metformin, and spironolactone)
* On medications known or likely to inhibit or induce CYP1A2 or CYP3A4 (please see "Restrictions on use of other drugs or treatments" section below for common examples of such drugs)
* Are currently participating in another study or have been in one in the last 30 days.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
13 Years
Maximum Age:
17 Years
Study:
NCT01428193
Study Brief:
Protocol Section:
NCT01428193