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:
2025-12-24 @ 3:32 PM
Ignite Modification Date:
2025-12-24 @ 3:32 PM
NCT ID:
NCT04060992
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers from USC Fertility
* Documented ovulation with a serum mid-luteal progesterone ≥3pg/mL
* Ovulatory with a 24-35-day cycle
* Ages 18-39
* Body Mass Index (BMI) 18.1-30.0kg/m2
* Consistent condom use for contraception
* Not desiring or seeking pregnancy
Exclusion Criteria:
* Allergy to injectable or oral GnRH-antagonist
* FSH ≥ 10 IU/L or LH ≥ 10 IU/L in early follicular phase iii. Known liver disease iv. Known osteoporosis v. Pregnancy vi. Current use of drugs metabolized by the liver enzyme CYP3A, specifically ketoconazole, rifampin, digoxin, oral midazolam, or rosuvastatin.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
39 Years
Study:
NCT04060992
Study Brief:
Protocol Section:
NCT04060992