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 @ 7:52 PM
Ignite Modification Date:
2025-12-24 @ 7:52 PM
NCT ID:
NCT00326404
Eligibility Criteria:
Inclusion Criteria:
* Female
* Age 15 to 18
* Presenting to the Gynecology and Adolescent Medicine Clinic for contraception
Exclusion Criteria:
* Prior use of the study medication with no improvement in symptoms
* Any medical condition that indicates continuous OCPs (i.e. acute menorrhagia, dysmenorrhea that did not previously respond to cyclical OCP use)
* Personal history of or current thromboembolic disorder
* First-degree relative(s) with thromboembolic disorder
* Cerebrovascular disease
* Coronary artery disease
* Cardiac valvular disease
* Hypertension (systolic blood pressure \> 160 mmHg or diastolic \> 100 mmHG)
* Diabetes with retinopathy/neuromyopathy/nephropathy)
* Breast cancer
* Endometrial cancer
* Undiagnosed abnormal uterine bleeding
* Cholestatic jaundice of pregnancy
* Hepatic tumor
* Known or suspected pregnancy
* Less than 6 months postpartum if breastfeeding
* Classic migraine with aura or any other neurological signs
* Gallbladder disease
* Taking any medications known to affect the efficacy of OCPs (i.e. phenytoin, phenobarbital, primidone, carbamazepine, griseofulvin, rifampin)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
15 Years
Maximum Age:
18 Years
Study:
NCT00326404
Study Brief:
Protocol Section:
NCT00326404