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

Endometriosis and Dysmenorrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03126747
• Other study ID #: 18703
• Status: Completed
• Start date: June 29, 2017
• Est. completion date: November 17, 2021

Study information

• Verified date: November 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 715
• Est. completion date: November 17, 2021
• Est. primary completion date: June 17, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Endometriosis
• Endometriosis and Dysmenorrhea
• Pelvic Pain

Intervention

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.

Locations

Country	Name	City	State
Japan	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Incidence proportions of YAZ-Flex therapy		Up to 2 years ( 1 year at the earliest)
Secondary	Incidence proportions of extent of bleeding		Up to 2 years ( 1 year at the earliest)
Secondary	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)
Secondary	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)
Secondary	Number of date of using analgesic	Record the date of using the analgesic.	Up to 2 years ( 1 year at the earliest)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

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