Post Marketing Surveillance To Observe Safety And Efficacy Of Sayana® Used For Contraception And Management Of Endometriosis-Associated Pain
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
362
Non intervention
Non intervention
Inje University Haeundae Paik Hospital
Haeundae-gu, Busan, South Korea
Bundang Cha Medical Center
Seongnam-si, Gyeonggi-do, South Korea
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline up to 12 months
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CHA Bundang Medical Center-CHA University
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Soon Chun Hyang University Hospital Seoul
Seoul, Korea, South Korea
Ulsan University Hospital
Ulsan, Korea, South Korea
Min Hyunju Women's Clinic
Busan, South Korea
Keimyung University Dongsan Hospital
Daegu, South Korea
Inje University Sanggye Paik Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
...and 9 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Month 12