Post Marketing Surveillance Study For Sayana®

NCT02104557

Last updated date
Study Location
Inje University Haeundae Paik Hospital
Haeundae-gu, Busan, 48108, Korea, Republic of
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

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Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Postmarketing Product Surveillance
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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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Postmarketing Product SurveillancePost Marketing Surveillance Study For Sayana®
NCT02104557
  1. Haeundae-gu, Busan
  2. Seoul,
  3. Seoul,
  4. Seoul,
  5. Seongnam-si, Gyeonggi-do
  6. Seongnam-si, Gyeonggi-do
  7. Seongnam-si, Gyeonggi-do
  8. Suwon-si, Gyeonggi-do
  9. Seoul, Korea
  10. Ulsan, Korea
  11. Busan,
  12. Daegu,
  13. Seoul,
  14. Seoul,
  15. Seoul,
  16. Seoul,
  17. Seoul,
  18. Seoul,
  19. Seoul,
  20. Seoul,
Female
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
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
  • prevention of pregnancy
    Non intervention
    Intervention: Other: Non intervention
  • management of endometriosis-associated pain
    Non intervention
    Intervention: Other: Non intervention
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 Recruiting
Estimated Enrollment
 (submitted: April 1, 2014)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date August 25, 2020
Estimated Primary Completion Date August 25, 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:

  • 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.
Sex/Gender
Sexes Eligible for Study:Female
Gender Based Eligibility:Yes
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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
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/d….
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date November 2019