Trial Condition(s):

Endometriosis and Dysmenorrhea

Drug Use Investigation (DUI) of YazFlex for endometriosis-associated pelvic pain and/or dysmenorrhea

Bayer Identifier:

18703

ClinicalTrials.gov Identifier:

NCT03126747

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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.

Trial Summary

Enrollment Goal
715
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Japan

Status
Completed
 

Trial Design