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 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT02104557
Eligibility Criteria:
Inclusion Criteria:
\- Subjects or legally authorized representatives of pediatric subjects agree to provide written informed consent form (ie, data privacy statement).
2.Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage
Exclusion Criteria:
* Known or suspected pregnancy.
* Undiagnosed vaginal bleeding.
* Known or suspected malignancy of breast.
* Active thrombophlebitis, or current or past history of thromboembolic disorders, or cerebral vascular disease.
* Significant liver disease.
* Known hypersensitivity to medroxyprogesterone acetate or any of its other ingredients.
* Women who are before menarche or who are post-menopausal.
* Treatment with any investigational agent or device within 30 days prior to the enrollment visit.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
0 Years
Study:
NCT02104557
Study Brief:
Protocol Section:
NCT02104557