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Post Marketing Surveillance Study For Sayana® (SAYANA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104557
Recruitment Status : Recruiting
First Posted : April 4, 2014
Last Update Posted : November 8, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Condition or disease Intervention/treatment
Product Surveillance, Postmarketing Other: Non intervention

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

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF SAYANA(REGISTERED) USED FOR CONTRACEPTION AND MANAGEMENT OF ENDOMETRIOSIS-ASSOCIATED PAIN
Actual Study Start Date : March 19, 2014
Estimated Primary Completion Date : August 25, 2020
Estimated Study Completion Date : August 25, 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
prevention of pregnancy
Non intervention
Other: Non intervention
Non intervention

management of endometriosis-associated pain
Non intervention
Other: Non intervention
Non intervention




Primary Outcome Measures :
  1. Cumulative percent of patients who become pregnant over the 6 month observation period and rate of pregnancies per 100 person-years of follow-up [ Time Frame: 6 month ]
  2. The patient response to endometriosis pain treatment: endometriosis pain treatment effect will be measured by visual analogue scale scores recorded by the subjects at each visit. [ Time Frame: 3 month ]
    The subject will be asked to indicate the subjective level of endometriosis pain looking back at the last 3 months and mark it with a single vertical mark on the 100mm horizontal visual analogue scale, where 0 mm represents absence of pain and 100mm indicates unbearable pain

  3. Incidence of adverse events categorized according to physical organ and disease/symptom. [ Time Frame: 6 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104557


Contacts
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Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations
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Korea, Republic of
Inje University Haeundae Paik Hospital Recruiting
Haeundae-gu, Busan, Korea, Republic of, 48108
Bundang Cha Medical Center Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
CHA Bundang Medical Center-CHA University Not yet recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
CHA Bundang Medical Center-CHA University Recruiting
Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
Ajou University Hospital Recruiting
Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
Soon Chun Hyang University Hospital Seoul Recruiting
Seoul, Korea, Korea, Republic of, 04401
Ulsan University Hospital Recruiting
Ulsan, Korea, Korea, Republic of, 44033
Min Hyunju Women's Clinic Recruiting
Busan, Korea, Republic of
Keimyung University Dongsan Hospital Recruiting
Daegu, Korea, Republic of, 41931
Inje University Sanggye Paik Hospital Recruiting
Seoul, Korea, Republic of, 01757
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 05030
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Gangnam Severance Hospital Not yet recruiting
Seoul, Korea, Republic of, 06273
Chung-Ang University Hospital Recruiting
Seoul, Korea, Republic of, 06973
Ewha Womans University Mokdong Hospital Recruiting
Seoul, Korea, Republic of, 07985
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 120-752
CHA Gangnam Medical Center, CHA University Active, not recruiting
Seoul, Korea, Republic of, 135-913
Roen Clinic Active, not recruiting
Seoul, Korea, Republic of, 135-932
Nana Clinic Recruiting
Seoul, Korea, Republic of, 137-809
Avenue Clinic Active, not recruiting
Seoul, Korea, Republic of, 139-832
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02104557     History of Changes
Other Study ID Numbers: A6791036
First Posted: April 4, 2014    Key Record Dates
Last Update Posted: November 8, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
Sayana
Pregnancy
Contraception
Endometriosis-associated pain
PMS
Post Marketing Surveillance
Additional relevant MeSH terms:
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Endometriosis
Genital Diseases, Female