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

Completed

• Conditions: Endometriosis and Dysmenorrhea
• Interventions: Drug: BAY86-5300_YAZ-Flex

• Registration Number: NCT03126747
• Lead Sponsor: Bayer

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-04-20
• Study First Submitted QC: 2017-04-20
• Study First Posted: 2017-04-24
• Study Start: 2017-06-29
• Primary Completion: 2021-06-17
• Study Completion: 2021-11-17
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-13
• Last Update Posted: 2022-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 715

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.

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Exclusion Criteria

• Patients participating in an investigational program with interventions outside of routine clinical practice.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
BAY86-5300_YAZ-Flex	BAY86-5300_YAZ-Flex	Patients with endometriosis-associated pelvic pain or dysmenorrhea

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	Up to 2 years ( 1 year at the earliest)	The duration of suspension is defined as a period of at least 3 consecutive days of treatment suspension.
Number of days with menstrual pain	Up to 2 years ( 1 year at the earliest)	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.
Number of date of using analgesic	Up to 2 years ( 1 year at the earliest)	Record the date of using the analgesic.
Change in severity of dysmenorrhea	Up to 2 years ( 1 year at the earliest)	The severity will be evaluated and recorded the following criteria.; 1. None; 2. Somewhat obstructing work (school or housework); 3. get a problem with one's work (studies / housework) because the more one wants to lie down; 4. Fall asleep for more than 1 day, and cannot do one's work (school or housework)
Change in severity of pelvic pain by using Numeric Rating Scale (NRS)	Up to 2 years ( 1 year at the earliest)	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.
Change in quality of Life by using EQ-5D-5L , EIS and/or MDQ	Up to 2 years ( 1 year at the earliest)	Endometriosis Impact Scale (EIS) (for disease burden of endometriosis) Menstrual Distress Questionnaire (MDQ) (for disease burden of dysmenorrhea) EQ-5D (for general QOL measurement)

Trial Locations

Locations (1)

Many locations; 🇯🇵 Multiple Locations, Japan