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

NCT ID: NCT03126747

Last Updated: 2022-11-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 715 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-06-29
• Study Completion Date: 2021-11-17

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.

Conditions

Endometriosis and Dysmenorrhea

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

BAY86-5300_YAZ-Flex

Patients with endometriosis-associated pelvic pain or dysmenorrhea

BAY86-5300_YAZ-Flex

Intervention Type: DRUG

Patients with endometriosis-associated pelvic pain and/or dysmenorrhea are enrolled solely after the physician's decision of YazFlex treatment in routine clinical practice.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many locations

Multiple Locations, , Japan

Countries

Japan

References

Yoshino O, Suzukamo Y, Yoshihara K, Takahashi N. Quality of Life in Japanese Patients with Dysmenorrhea or Endometriosis-Associated Pelvic Pain Treated with Extended Regimen Ethinylestradiol/Drospirenone in a Real-World Setting: A Prospective Observational Study. Adv Ther. 2022 Nov;39(11):5087-5104. doi: 10.1007/s12325-022-02301-3. Epub 2022 Sep 2.

Reference Type: DERIVED

PMID: 36053449 (View on PubMed)

Related Links

http://clinicaltrials.bayer.com/

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Other Identifiers

18703

Identifier Type: -

Identifier Source: org_study_id