N/A
Completed N=362
Post Marketing Surveillance Study For Sayana®
Product Surveillance, Postmarketing
Source: ClinicalTrials.gov NCT02104557 ↗
Enrolled (actual)
362
Serious AEs
0.3%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) — 81; 1 Participants
Summary
Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |
81; 1 | — |
| PRIMARY Number of Participants Discontinued From Study Due to AEs |
22 | — |
| PRIMARY Number of Participants Used Concomitant Medications for Treating AEs |
54 | — |
| PRIMARY Number of Participants With Clinically Significant Laboratory Test Abnormalities |
— | — |
| PRIMARY Percentage of Participants Who Became Pregnant Over Observation Period |
— | — |
| PRIMARY Rate of Pregnancies Per 100 Participant-years of Follow-up |
— | — |
| PRIMARY Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug |
48.32; -29.63 | — |
| PRIMARY Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug |
-33.02 | — |
| PRIMARY Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug |
-37.8 | — |
| PRIMARY Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug |
-49.25 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02104557). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.