Post Marketing Surveillance Study For Sayana®

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

Detailed Description
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Post Marketing Surveillance required by Korea MFDS regulation. Select among patients who randomly visit the site who meet the inclusion/exclusion criteria.

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

Conditions
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Product Surveillance, Postmarketing

Intervention / Treatment
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* Other: Non intervention
* Other: Non intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 0 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| prevention of pregnancy<br>Non intervention | Other: Non intervention<br>* Non intervention<br>|
| management of endometriosis-associated pain<br>Non intervention | Other: Non intervention<br>* Non intervention<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sayana, Pregnancy, Contraception, Endometriosis-associated pain, PMS, Post Marketing Surveillance