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Post Marketing Surveillance Study For Sayana® (SAYANA)

Pfizer logo

Pfizer

Status

Completed

Conditions

Product Surveillance, Postmarketing

Treatments

Other: Non intervention

Study type

Observational

Funder types

Industry

Identifiers

NCT02104557
A6791036

Details and patient eligibility

About

Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain

Full description

Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.

Enrollment

362 patients

Sex

Female

Volunteers

No Healthy Volunteers

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.

Trial design

362 participants in 2 patient groups

prevention of pregnancy
Description:
Non intervention
Treatment:
Other: Non intervention
Other: Non intervention
management of endometriosis-associated pain
Description:
Non intervention
Treatment:
Other: Non intervention
Other: Non intervention

Trial documents
2

Trial contacts and locations

19

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Data sourced from clinicaltrials.gov

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