check_circleStudy Completed
Dysmenorrhea
Bayer Identifier:
15328
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
YAZ post-marketing surveillance in Japan
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.
Key Participants Requirements
Sex
FemaleAge
NaN - N/ATrial summary
Enrollment Goal
3273Trial Dates
June 2011 - March 2018Phase
Phase 4Could I Receive a placebo
NoProducts
YAZ (EE20/DRSP, BAY86-5300)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions and sever adverse eventsdate_rangeTime Frame:During YAZ administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
- Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)date_rangeTime Frame:Baseline and during YAZ administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence of adverse eventsdate_rangeTime Frame:During YAZ administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
- Unpleasant physical symptoms collectiondate_rangeTime Frame:Baseline and during YAZ administration, up to 3 yearsenhanced_encryptionNoSafety Issue:
- Unpleasant psychological symptoms collectiondate_rangeTime Frame:Baseline and during YAZ administration, up to 3 yearsenhanced_encryptionNoSafety Issue:
- Analgesic drug for dysmenorrheadate_rangeTime Frame:During YAZ administration, up to 3 yearsenhanced_encryptionNoSafety Issue:
- QOL survey using Short-Form 36-Item Health Survey (SF-36)date_rangeTime Frame:Baseline and at 6th - 8th cycles (28 datys per cycle)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A