Post Marketing Surveillance Study For Sayana®

NCT ID: NCT02104557

Last Updated: 2021-06-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

362 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-13

Study Completion Date

2020-06-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Product Surveillance, Postmarketing

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

prevention of pregnancy

Non intervention

Non intervention

Intervention Type OTHER

Non intervention

management of endometriosis-associated pain

Non intervention

Non intervention

Intervention Type OTHER

Non intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Non intervention

Non intervention

Intervention Type OTHER

Non intervention

Non intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

0 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Inje University Haeundae Paik Hospital

Haeundae-gu, Busan, South Korea

Site Status

Bundang Cha Medical Center

Seongnam-si, Gyeonggi-do, South Korea

Site Status

CHA Bundang Medical Center-CHA University

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Ajou University Hospital

Suwon, Gyeonggi-do, South Korea

Site Status

Soon Chun Hyang University Hospital Seoul

Seoul, Korea, South Korea

Site Status

Ulsan University Hospital

Ulsan, Korea, South Korea

Site Status

Min Hyunju Women's Clinic

Busan, , South Korea

Site Status

Keimyung University Dongsan Hospital

Daegu, , South Korea

Site Status

Inje University Sanggye Paik Hospital

Seoul, , South Korea

Site Status

Konkuk University Medical Center

Seoul, , South Korea

Site Status

Asan Medical Center

Seoul, , South Korea

Site Status

Samsung Medical Center

Seoul, , South Korea

Site Status

Chung-Ang University Hospital

Seoul, , South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status

CHA Gangnam Medical Center, CHA University

Seoul, , South Korea

Site Status

Roen Clinic

Seoul, , South Korea

Site Status

Nana Clinic

Seoul, , South Korea

Site Status

Avenue Clinic

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A6791036

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Endometrial Safety Study
NCT00522873 COMPLETED PHASE3
Effect on Primary Dysmenorrhea
NCT00909857 COMPLETED PHASE3