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

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis and Dysmenorrhea
• Intervention / Treatment: Drug: BAY86-5300_YAZ-Flex

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.

• Study Type: Observational
• Enrollment (Actual): 715

Contacts and Locations

Study Locations

• Japan
  • Multiple Locations, Japan
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Endometriosis-associated pelvic pain and/or Dysmenorrhea

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
BAY86-5300_YAZ-Flex; Patients with endometriosis-associated pelvic pain or dysmenorrhea	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 29, 2017
• Primary Completion (ACTUAL): June 17, 2021
• Study Completion (ACTUAL): November 17, 2021

Study Registration Dates

• First Submitted: April 20, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (ACTUAL): April 24, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 13, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Endometriosis; Dysmenorrhea; Pelvic Pain
• Other Study ID Numbers: 18703

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No