Trial Condition(s):
Dysmenorrhea
YAZ post-marketing surveillance in Japan
Bayer Identifier:
15328
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT 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
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
| Locations | |
|---|---|
Locations Investigative Site Many locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug use investigation of YAZ
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Incidence of adverse drug reactions and sever adverse eventsTimeframe: During YAZ administration, up to 3 years
- Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)Timeframe: Baseline and during YAZ administration, up to 3 years
Secondary Outcome
- Incidence of adverse eventsTimeframe: During YAZ administration, up to 3 years
- Unpleasant physical symptoms collectionTimeframe: Baseline and during YAZ administration, up to 3 years
- Unpleasant psychological symptoms collectionTimeframe: Baseline and during YAZ administration, up to 3 years
- Analgesic drug for dysmenorrheaTimeframe: During YAZ administration, up to 3 years
- QOL survey using Short-Form 36-Item Health Survey (SF-36)Timeframe: Baseline and at 6th - 8th cycles (28 datys per cycle)
Additional Information
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