check_circleStudy Completed

Dysmenorrhea

Bayer Identifier:

15328

ClinicalTrials.gov Identifier:

NCT01375998

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

Female

Age

NaN - N/A
  • - Patients who received YAZ for dysmenorrhea
    Additional criteria for QOL questionnaire
    - Patient informed consent
  • - 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
June 2011 - March 2018
Phase
Phase 4
Could I Receive a placebo
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions and sever adverse events
    date_rangeTime Frame:
    During YAZ administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • 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 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of adverse events
    date_rangeTime Frame:
    During YAZ administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Unpleasant physical symptoms collection
    date_rangeTime Frame:
    Baseline and during YAZ administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Unpleasant psychological symptoms collection
    date_rangeTime Frame:
    Baseline and during YAZ administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Analgesic drug for dysmenorrhea
    date_rangeTime Frame:
    During YAZ administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • 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_encryption
    Safety Issue:
    No

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
N/A

Additional Information

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