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 @ 1:38 PM
Ignite Modification Date:
2025-12-24 @ 1:38 PM
NCT ID:
NCT00236795
Eligibility Criteria:
Inclusion Criteria:
* Healthy, nonpregnant women with regular menstrual cycles
* sexually active and at risk of pregnancy
* acceptable body mass index (BMI)
* last term pregnancy at least 42 days prior, nonlactating, with 1 normal menstrual cycle since
* sitting BP\<140mmHg/\<90mmHg
* 1 normal menstrual cycle since removal of IUD or norplant
* agreement to use study drug for contraception for up to 13 cycles, except when backup contraception is required for disease protection or patch detachment
* agree not to use other systemic steroid medication
Exclusion Criteria:
* Presence, history, hereditary predisposition or risk of deep vein thrombophlebitis or thromboembolic disorders
* cerebral vascular or coronary artery disease, hypertension, or severe migraines
* liver tumor resulting from estrogen-containing products
* diabetes mellitus
* cholestatic jaundice, liver or renal disease
* abnormal PAP smear
* undiagnosed abnormal vaginal bleeding
* thyroid disorder
* dermal hypersensitivity
* carcinoma of breast, genital tract or other estrogen-dependent neoplasia
* received any depot hormone injection within prior 6 months
* smoking women over 35 years of age.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00236795
Study Brief:
Protocol Section:
NCT00236795