Post Marketing Surveillance Study For Sayana® (SAYANA)

POST MARKETING SURVEILLANCE TO OBSERVE SAFETY AND EFFICACY OF SAYANA(REGISTERED) USED FOR CONTRACEPTION AND MANAGEMENT OF ENDOMETRIOSIS-ASSOCIATED PAIN

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

Study Overview

• Status: Completed
• Conditions: Product Surveillance, Postmarketing
• Intervention / Treatment: 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.

• Study Type: Observational
• Enrollment (Actual): 362

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Min Hyunju Women's Clinic
  • Daegu, Korea, Republic of, 41931
    • Keimyung University Dongsan Hospital
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06973
    • Chung-Ang University Hospital
  • Seoul, Korea, Republic of, 07985
    • Ewha Womans University Mokdong Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 120-752
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 01757
    • Inje University Sanggye Paik Hospital
  • Seoul, Korea, Republic of, 135-913
    • CHA Gangnam Medical Center, CHA University
  • Seoul, Korea, Republic of, 135-932
    • Roen Clinic
  • Seoul, Korea, Republic of, 137-809
    • Nana Clinic
  • Seoul, Korea, Republic of, 139-832
    • Avenue Clinic
  • Busan
    • Haeundae-gu, Busan, Korea, Republic of, 48108
      • Inje University Haeundae Paik Hospital
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • Bundang CHA Medical Center
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 13496
      • CHA Bundang Medical Center-CHA University
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16499
      • Ajou University Hospital
  • Korea
    • Seoul, Korea, Korea, Republic of, 04401
      • Soon Chun Hyang University Hospital Seoul
    • Ulsan, Korea, Korea, Republic of, 44033
      • Ulsan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. AEs included both serious and all non-serious adverse events.	Baseline up to a maximum of 12 months
Number of Participants Discontinued From Study Due to AEs	Participants who discontinued permanently from the study due to AEs are reported. An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship.	Baseline up to a maximum of 12 months
Number of Participants Used Concomitant Medications for Treating AEs	Number of participants taking any medications other than Sayana (concomitant medication) to treat AEs are reported.	Baseline up to a maximum of 12 months
Number of Participants With Clinically Significant Laboratory Test Abnormalities	Laboratory tests included hematology, biochemistry, and urinalysis. Clinical significance was identified by investigators' judgements based on laboratory test results.	Baseline up to a maximum of 12 months
Percentage of Participants Who Became Pregnant Over Observation Period	The cumulative percent of participants who became pregnant over observation period was calculated as 100*(1- Kaplan-Meier curve at month 12), where the Kaplan-Meier (KM) method for estimating survival function was applied to time-to-pregnancy.	Baseline up to 12 months
Rate of Pregnancies Per 100 Participant-years of Follow-up	Pregnancies per 100 person-years of follow-up defined as major events, incidence rate was calculated as: 100*(total number of participants with effectiveness endpoint)/(total person-years of participants included in the effectiveness analysis set) where total person-years is equal to (last evaluation date of outcome - first date of administration +1)/365.25 for all participants in the effective analysis set.	Baseline up to 12 months
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug	Participants were 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 100 millimeter (mm) horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of first dose of study drug is reported in this outcome measure.	Baseline, Month 3
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug	Participants were 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 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of second dose of study drug is reported in this outcome measure.	Baseline, Month 6
Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug	Participants were 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 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of third dose of study drug is reported in this outcome measure.	Baseline, Month 9
Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug	Participants were 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 100 mm horizontal visual analogue scale, where 0 mm represented absence of pain and 100 mm indicated unbearable pain. Higher score indicated more pain. Change from baseline in pain VAS score after administration of fourth dose of study drug is reported in this outcome measure.	Baseline, Month 12

Collaborators and Investigators

• Sponsor: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 13, 2014
• Primary Completion (ACTUAL): June 5, 2020
• Study Completion (ACTUAL): June 5, 2020

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 1, 2014
• First Posted (ESTIMATE): April 4, 2014

Study Record Updates

• Last Update Posted (ACTUAL): June 10, 2021
• Last Update Submitted That Met QC Criteria: May 14, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Pregnancy; Contraception; PMS; Endometriosis-associated pain; Post Marketing Surveillance; Sayana
• Additional Relevant MeSH Terms: Endometriosis
• Other Study ID Numbers: A6791036

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD 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.