Overview

This trial is active, not recruiting.

Condition dysmenorrhea
Treatment ee20/drsp(yaz, bay86-5300)
Phase phase 4
Sponsor Bayer
Start date June 2011
End date May 2017
Trial size 3273 participants
Trial identifier NCT01375998, 15328, YAZ-DUI

Summary

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received YAZ for dysmenorrhea. The objective of this study is to assess safety and efficacy of using YAZ in clinical practice. A total 3,000 patients will be recruited and followed 3 years since starting YAZ administration.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
ee20/drsp(yaz, bay86-5300)
Patients in daily life treatment receiving YAZ for dysmenorrhea.

Primary Outcomes

Measure
Incidence of adverse drug reactions and sever adverse events
time frame: During YAZ administration, up to 3 years
Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)
time frame: Baseline and during YAZ administration, up to 3 years

Secondary Outcomes

Measure
Incidence of adverse events
time frame: During YAZ administration, up to 3 years
Unpleasant physical symptoms collection
time frame: Baseline and during YAZ administration, up to 3 years
Unpleasant psychological symptoms collection
time frame: Baseline and during YAZ administration, up to 3 years
Analgesic drug for dysmenorrhea
time frame: During YAZ administration, up to 3 years
QOL survey using Short-Form 36-Item Health Survey (SF-36)
time frame: Baseline and at 6th - 8th cycles (28 datys per cycle)

Eligibility Criteria

Female participants of any age.

Inclusion Criteria: - Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire - Patient informed consent Exclusion Criteria: - Patients who are contraindicated based on the product label Additional criteria for QOL questionnaire - Six months or less after treatment of estrogen or estrogen combination drug

Additional Information

Official title Drug Use Investigation of YAZ
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Bayer.