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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01963403
Eligibility Criteria:
Inclusion Criteria:
* Women who have an ETG implant in place
* Women who subjectively experience the side effect of an undesirable bleeding profile such as bleeding irregularity or heavy flow after ETG implant was placed and who desire intervention for this side effect by either treatment of bleeding or removal of the implant
* Age 14 years an older, inclusive
Exclusion Criteria:
* Irregular or heavy bleeding from an etiology other than ETG use (e.g. fibroids, cervical polyp, or other organic cause of bleeding)
* Has attempted prescription treatment for menstrual side effects while using ETG implant
* Has one or more of the conditions considered Category 3 (risks outweigh benefits) or Category 4 (unacceptable health risk) for estrogen-containing oral contraceptives by the Center for Disease Control Medical Eligibility Criteria for Contraceptive Use:
* Current or history of heart or vascular diseases, including deep venous thrombosis, pulmonary embolism, known thrombogenic mutations, peripartum cardiomyopathy, and complicated valvular heart disease
* Hypertension, even if adequately controlled
* Diabetes with vascular involvement
* Headaches with focal aura, or migraines in women age 35 and older even without focal aura
* Major surgery with prolonged immobilization
* Breast cancer (current or past)
* Severe (decompensated) cirrhosis
* Acute or flare viral hepatitis
* Breastfeeding less than 1 month postpartum
* Post-partum less than 3 weeks
* 35 years of age and older and smoking
* Multiple risk factors for arterial cardiovascular disease
* Systemic Lupus Erythematosus with positive or unknown antiphospholipid antibodies
* Current symptomatic gallbladder disease or history of cholestasis related to past combined oral contraceptive use
* On certain anticonvulsants (phenytoin, carbamazepine, barbiturates, primidone, topiramate, oxcarbazepine, lamotrigine)
* On Ritonavir-boosted protease inhibitors for antiretroviral therapy
* Issues or concerns, in the judgment of the investigator, that may compromise the safety of the subject, impact the subject's adherence to the protocol requirements, or confound the reliability of the data acquired in this study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
14 Years
Study:
NCT01963403
Study Brief:
Protocol Section:
NCT01963403