Trial Condition(s):

Dysmenorrhea

YAZ post-marketing surveillance in Japan

Bayer Identifier:

15328

ClinicalTrials.gov Identifier:

NCT01375998

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
3273
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many locations, Japan

Status
Completed
 

Trial Design