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:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT01656434
Eligibility Criteria:
Inclusion Criteria:
* Sexually active woman, at risk for pregnancy and in need of contraception
* Not planning to use other contraceptive methods (including barrier methods \[e.g., condoms\]) than the study drug, during the study
* Willing to use a COC for 12 months (13 cycles)
* Body mass index (BMI) of ≥18 and \<38 kg/m\^2
* Good physical and mental health
* Willing to complete an electronic diary on a daily basis for the duration of the study
Exclusion Criteria:
* Current smoker and age of \>35 years
* Presence or history of either venous thromboembolic diseases (deep vein thrombosis \[DVT\], pulmonary embolism) or arterial thromboembolic diseases (myocardial infarction, stroke)
* History of migraine with focal neurological symptoms
* Diabetes mellitus with vascular involvement
* Less than two weeks of full remobilization from prolonged immobilization, major surgery, any surgery to the legs, or major trauma
* Severe hypertension
* Severe abnormal lipoproteins in the blood
* Pancreatic dysfunction
* Presence of history of severe liver disease or liver tumors
* Known or suspected sex steroid-influenced malignancies (e.g., of the genital organs or the breasts)
* Undiagnosed vaginal bleeding
* Known or suspected pregnancy
* Current or history of abuse of alcohol or drugs (e.g., laxatives)
* Abnormal cervical smear at screening
* Prior to start of treatment, spontaneous menstruation has not occurred following a delivery or abortion
* Breastfeeding or has been breastfeeding within 2 months prior to start of treatment
* Use of any investigational drugs and/or participation in any other clinical trial within 2 months prior to start of treatment
* Use of any of the following medications prior to or during the study may prohibit inclusion: sex hormones (other than pre- and post-treatment non-injectable contraceptives), injectable hormonal contraception, phenytoin, barbiturates, primidone, bosentan, carbamazepine, topiramate, felbamate, rifampicin, ritonavir, nevirapine, efavirenz, griseofulvin, herbal remedies containing Hypericum perforatum (e.g., St. John's wort)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT01656434
Study Brief:
Protocol Section:
NCT01656434