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 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT00709332
Eligibility Criteria:
Inclusion Criteria:
* Healthy
* Nonpregnant
* Nonlactating
* Nonsmoking women
* Weighing at least 110 pounds
* With regular menstrual cycles
* A body mass index between 16 and 29.9 kg/m2
* And a hematocrit of at least 36%
Exclusion Criteria:
* History or presence of disorders commonly accepted as contraindications to sex hormonal therapy including: thromboembolic disorders cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines, benign or malignant liver tumor that developed during the use of OC
* Known or suspected estrogen-dependent neoplasia
* Presence of disorders commonly accepted as contraindications to combined OC including: undiagnosed abnormal vaginal bleeding, any neurovascular lesion of the eye or serious visual disturbance, or liver disease
* Intake any multivitamin or folic acid-containing supplements within 30 days before study admission
* Used a steroid hormone-containing intrauterine device within 3 months prior to study admission
* Used any medications that were known cytochrome P-450 enzyme inducers or inhibitors (e.g., St. John's Wort, cimetidine or rifampin), within 60 days before dosing.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00709332
Study Brief:
Protocol Section:
NCT00709332