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 @ 9:07 PM
Ignite Modification Date:
2025-12-24 @ 9:07 PM
NCT ID:
NCT00357604
Eligibility Criteria:
Inclusion Criteria:
* Women of childbearing potential with intact ovarian function who have been on a stable regimen of oral contraceptives for at least 2 months prior to beginning the study
* Documented acceptable Pap smear within 1 year prior to dosing
* Body mass index (BMI) 18-32 kg/m2
Exclusion Criteria:
* Males
* Subjects with an abnormal menstrual cycle during the 2 months prior to the start of the study or during the lead-in period (breakthrough bleeding/spotting)
* History of conditions where the use of oral contraceptives are contraindicated
* Known or suspected carcinoma or suspected estrogen dependent neoplasia
* History of migraine with focal aura
* History of uncontrolled hypertension
* Positive screening test for HIV-1, -2, HIV viral ribonucleic acid (RNA), hepatitis B surface antigen, or hepatitis C antibody
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00357604
Study Brief:
Protocol Section:
NCT00357604