Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT02104557
Previous Study | Return to List | Next Study

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 : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date April 1, 2014
First Posted Date April 4, 2014
Last Update Posted Date July 9, 2019
Actual Study Start Date March 2014
Estimated Primary Completion Date August 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 1, 2014)
  • 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 ]
  • 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
  • Incidence of adverse events categorized according to physical organ and disease/symptom. [ Time Frame: 6 month ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02104557 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 2020
Estimated Primary Completion Date August 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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests.
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date July 2019