NCT03126747

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 715 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis and Dysmenorrhea

Interventions

Type	Name	Description
DRUG	BAY86-5300_YAZ-Flex	Patients with endometriosis-associated pelvic pain and/or dysmenorrhea are enrolled solely after the physician's decision of YazFlex treatment in routine clinical practice.

Timeline

• Start date: 2017-06-29
• Primary completion: 2021-06-17
• Completion: 2021-11-17
• First posted: 2017-04-24
• Last updated: 2022-11-16

Locations

1 site across 1 country: Japan