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 @ 11:42 PM
Ignite Modification Date:
2025-12-24 @ 11:42 PM
NCT ID:
NCT00204451
Eligibility Criteria:
Inclusion Criteria:
1. Female volunteers of childbearing potential;
2. Are first time users of oral contraception (OC) or have discontinued OC at least 1 month prior to study entry;
3. Age between 18 and 40 years old;
4. Normal body mass index (18-38);
5. Has signed informed consent form; and
6. Is in good health as confirmed by medical history, physical examination.
Exclusion Criteria:
1. A positive pregnancy test will automatically exclude the volunteer from participation in this study.
2. Any contraindication for oral contraception use;
3. Irregular menstrual cycles;
4. Ultrasonographic evidence of ovarian dysfunction, such as polycystic ovary syndrome (PCOS);
5. Pregnancy (suspected or diagnosed) or lactation;
6. History or suspicion of drug or alcohol abuse;
7. Participation in an investigational drug trial within the 30 days prior to selection;
8. Exhibits a disorder that is a contraindication to steroid hormonal therapy, including, for example, the following conditions:
* history of, or actual, thrombophlebitis or thromboembolic disorders.
* history of, or actual, cerebrovascular disorders.
* history of, or actual, myocardial infarction or coronary artery disease.
* acute liver disease.
* history of, or actual, benign or malignant liver tumors.
* history of, or suspected, carcinoma of the breast.
* known, or suspected, estrogen-dependent neoplasia.
* undiagnosed abnormal vaginal bleeding.
* any ocular lesion arising from ophthalmic vascular disease, such as partial or complete loss of vision or defect in visual field.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT00204451
Study Brief:
Protocol Section:
NCT00204451