Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea

Study Overview
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Brief Summary
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This study is a Japanese post-marketing surveillance (PMS) which is required by the regulatory authorities. General objective of PMS is to confirm the clinical usefulness, especially the safety profile of a drug under the routine clinical practice.

Detailed Description
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It is a local, non-interventional, multi-center, single-cohort study using primary data of patients treated with YazFlex in endometriosis or dysmenorrhea indication. A total of 600 patients (300 for endometriosis and 300 for dysmenorrhea) is planned to be enrolled in 2 years. The treatment should be performed in Japan based on the product label. The patients will be observed for up to 2 years (1 year at the earliest) during their YazFlex treatment. The outcome variables for the primary objective are treatment emergent adverse events (TEAEs) and adverse drug reactions (ADRs). The outcome variables for the secondary objective include newly developed haemorrhagic ovarian cyst, genital bleeding, severity of dysmenorrhea, pelvic pain and compliance status in the new flexible regimen.

Official Title
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Drug Use Investigation (DUI) of YazFlex for Endometriosis-associated Pelvic Pain and/or Dysmenorrhea

Conditions
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Endometriosis and Dysmenorrhea

Intervention / Treatment
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* Drug: BAY86-5300_YAZ-Flex


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with endometriosis-associated pelvic pain and/or dysmenorrhea. Patients for whom the decision to initiate treatment with YazFlex is made as per physician's clinical practice. Exclusion Criteria: - Patients participating in an investigational program with interventions outside of routine clinical practice.
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 |
| --- | --- |
| BAY86-5300_YAZ-Flex<br>Patients with endometriosis-associated pelvic pain or dysmenorrhea | Drug: BAY86-5300_YAZ-Flex<br>* Patients with endometriosis-associated pelvic pain and/or dysmenorrhea are enrolled solely after the physician's decision of YazFlex treatment in routine clinical practice.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse drug reactions (ADRs) | Events will be summarized by frequency tables (e.g. absolute and relative frequencies) using the MedDRA cording system. | Up to 2 years ( 1 year at the earliest) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence proportions of YAZ-Flex therapy |  | Up to 2 years ( 1 year at the earliest) | 
| Incidence proportions of extent of bleeding |  | Up to 2 years ( 1 year at the earliest) | 
| Incidence proportions of treatment suspension | The duration of suspension is defined as a period of at least 3 consecutive days of treatment suspension. | Up to 2 years ( 1 year at the earliest) | 
| Number of days with menstrual pain | Menstrual pain is continuous menstrual pain or lower abdominal pain that is observed for menstruation or withdrawal blood events and may spread to the back or thigh. Pain may be recognized 2 days before bleeding, and ends by the last day of menstruation or withdrawal. | Up to 2 years ( 1 year at the earliest) | 
| Number of date of using analgesic | Record the date of using the analgesic. | Up to 2 years ( 1 year at the earliest) | 
| Change in severity of dysmenorrhea | The severity will be evaluated and recorded the following criteria. None Somewhat obstructing work (school or housework) get a problem with one's work (studies / housework) because the more one wants to lie down Fall asleep for more than 1 day, and cannot do one's work (school or housework) | Up to 2 years ( 1 year at the earliest) | 
| Change in severity of pelvic pain by using Numeric Rating Scale (NRS) | The degree of pelvic pain in each menstrual period, menstrual period, sexual intercourse and defecation will be evaluated using NRS score (11 levels from no pain is 0 to highest pain 10 ) in each month. | Up to 2 years ( 1 year at the earliest) | 
| Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ | Endometriosis Impact Scale (EIS) (for disease burden of endometriosis) Menstrual Distress Questionnaire (MDQ) (for disease burden of dysmenorrhea) EQ-5D (for general QOL measurement) | Up to 2 years ( 1 year at the earliest) |