Clinical trial NCT02104557: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Product Surveillance, Postmarketing
Keywords: Sayana
Pregnancy
Contraception
Endometriosis-associated pain
PMS
Post Marketing Surveillance
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2014-04-04
Enrollment: 362
Sex: FEMALE
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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

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.

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.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to a maximum of 12 months
measure: Number of Participants Discontinued From Study Due to AEs
timeFrame: Baseline up to a maximum of 12 months
measure: Number of Participants Used Concomitant Medications for Treating AEs
timeFrame: Baseline up to a maximum of 12 months
measure: Number of Participants With Clinically Significant Laboratory Test Abnormalities
timeFrame: Baseline up to a maximum of 12 months
measure: Percentage of Participants Who Became Pregnant Over Observation Period
timeFrame: Baseline up to 12 months
measure: Rate of Pregnancies Per 100 Participant-years of Follow-up
timeFrame: Baseline up to 12 months
measure: Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of First Dose (Month 3) of Study Drug
timeFrame: Baseline, Month 3
measure: Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Second Dose (Month 6) of Study Drug
timeFrame: Baseline, Month 6
measure: Change From Baseline in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Third Dose (Month 9) of Study Drug
timeFrame: Baseline, Month 9
measure: Change From Baseline in in Endometriosis Pain Visual Analogue Scale (VAS) Scores After Administration of Fourth Dose (Month 12) of Study Drug
timeFrame: Baseline, Month 12
Secondary outcomes:
Other outcomes:
Locations:
city: Haeundae-gu
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
state: Busan
city: Seongnam-si
country: Korea, Republic of
facility: Bundang Cha Medical Center
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center-CHA University
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Hospital Seoul
state: Korea
city: Ulsan
country: Korea, Republic of
facility: Ulsan University Hospital
state: Korea
city: Busan
country: Korea, Republic of
facility: Min Hyunju Women's Clinic
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital
city: Seoul
country: Korea, Republic of
facility: Inje University Sanggye Paik Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang University Hospital
city: Seoul
country: Korea, Republic of
facility: Ewha Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center, CHA University
city: Seoul
country: Korea, Republic of
facility: Roen Clinic
city: Seoul
country: Korea, Republic of
facility: Nana Clinic
city: Seoul
country: Korea, Republic of
facility: Avenue Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: