ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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.
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Descriptive Information | |||||
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Brief Title | Post Marketing Surveillance Study For Sayana® | ||||
Official Title | POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF SAYANA(REGISTERED) USED FOR CONTRACEPTION AND MANAGEMENT OF ENDOMETRIOSIS-ASSOCIATED PAIN | ||||
Brief Summary | Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain | ||||
Detailed Description | Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria. | ||||
Study Type | Observational | ||||
Study Design | Observational Model: Other Time Perspective: Prospective | ||||
Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage | ||||
Condition | Product Surveillance, Postmarketing | ||||
Intervention | Other: Non intervention
Non intervention | ||||
Study Groups/Cohorts |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||
Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment | 362 | ||||
Original Estimated Enrollment | 600 | ||||
Actual Study Completion Date | June 5, 2020 | ||||
Actual Primary Completion Date | June 5, 2020 (Final data collection date for primary outcome measure) | ||||
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:
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Sex/Gender |
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Ages | Child, Adult, Older Adult | ||||
Accepts Healthy Volunteers | No | ||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries | Korea, Republic of | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number | NCT02104557 | ||||
Other Study ID Numbers | A6791036 | ||||
Has Data Monitoring Committee | No | ||||
U.S. FDA-regulated Product | Not Provided | ||||
IPD Sharing Statement |
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Responsible Party | Pfizer | ||||
Study Sponsor | Pfizer | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Pfizer | ||||
Verification Date | October 2020 |