- 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
- 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.