Post Marketing Surveillance Study For Sayana®

NCT02104557 | Completed Results

• 1 other identifier: A6791036
• Study Type: observational
• Target: 362
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Product Surveillance, Postmarketing

Keywords

Sayana; Pregnancy; Contraception; Endometriosis-associated pain; PMS; Post Marketing Surveillance

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

prevention of pregnancy

Non intervention

Other: Non intervention

management of endometriosis-associated pain

Non intervention

Other: Non intervention

Interventions

Non intervention OTHER

Non intervention

prevention of pregnancy

Eligibility Criteria

• Age: 0 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- Subjects or legally authorized representatives of pediatric subjects agree to provide written informed consent form (ie, data privacy statement).
• Women subjects who are initiating treatment with Sayana® for the first time as per the local product document for usage

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

Inje University Haeundae Paik Hospital

Haeundae-gu, Busan, 48108, South Korea

Location

Bundang Cha Medical Center

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

CHA Bundang Medical Center-CHA University

Seongnam-si, Gyeonggi-do, 13496, South Korea

Location

Ajou University Hospital

Suwon, Gyeonggi-do, 16499, South Korea

Location

Soon Chun Hyang University Hospital Seoul

Seoul, Korea, 04401, South Korea

Location

Ulsan University Hospital

Ulsan, Korea, 44033, South Korea

Location

Min Hyunju Women's Clinic

Busan, South Korea

Location

Keimyung University Dongsan Hospital

Daegu, 41931, South Korea

Location

Inje University Sanggye Paik Hospital

Seoul, 01757, South Korea

Location

Konkuk University Medical Center

Seoul, 05030, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Chung-Ang University Hospital

Seoul, 06973, South Korea

Location

Ewha Womans University Mokdong Hospital

Seoul, 07985, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, 120-752, South Korea

Location

CHA Gangnam Medical Center, CHA University

Seoul, 135-913, South Korea

Location

Roen Clinic

Seoul, 135-932, South Korea

Location

Nana Clinic

Seoul, 137-809, South Korea

Location

Avenue Clinic

Seoul, 139-832, South Korea

Location

Related Links

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

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2014
• First Posted: April 4, 2014
• Study Start: February 13, 2014
• Primary Completion: June 5, 2020
• Study Completion: June 5, 2020
• Last Updated: June 10, 2021
• Results First Posted: June 10, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (19)