YAZ Post-marketing Surveillance in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3273 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-09

Study Completion Date

2018-03-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Dysmenorrhea

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

EE20/DRSP(YAZ, BAY86-5300)

Intervention Type DRUG

Patients in daily life treatment receiving YAZ for dysmenorrhea.

Interventions

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EE20/DRSP(YAZ, BAY86-5300)

Patients in daily life treatment receiving YAZ for dysmenorrhea.

Intervention Type DRUG

Eligibility Criteria

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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

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No