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YAZ Post-marketing Surveillance in Japan

This study is currently recruiting participants.
Verified April 2013 by Bayer
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01375998
First received: June 8, 2011
Last updated: April 18, 2013
Last verified: April 2013
History of Changes
  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.


Condition Intervention
Dysmenorrhea
 Drug: EE20/DRSP(YAZ, BAY86-5300)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of YAZ

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and sever adverse events [ Time Frame: During YAZ administration, up to 3 years ] [ Designated as safety issue: Yes ]
  • Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle) [ Time Frame: Baseline and during YAZ administration, up to 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: During YAZ administration, up to 3 years ] [ Designated as safety issue: Yes ]
  • Unpleasant physical symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ] [ Designated as safety issue: No ]
  • Unpleasant psychological symptoms collection [ Time Frame: Baseline and during YAZ administration, up to 3 years ] [ Designated as safety issue: No ]
  • Analgesic drug for dysmenorrhea [ Time Frame: During YAZ administration, up to 3 years ] [ Designated as safety issue: No ]
  • QOL survey using Short-Form 36-Item Health Survey (SF-36) [ Time Frame: Baseline and at 6th - 8th cycles (28 datys per cycle) ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000
Study Start Date: June 2011
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: EE20/DRSP(YAZ, BAY86-5300)
Patients in daily life treatment receiving YAZ for dysmenorrhea

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The target population of this study is patients who have received a prescription of YAZ on the basis of the decision of the treating gynecologist. The study is expected to collect data of 3,000 patients in about 300 gynecological practices in Japan.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375998

Contacts
Contact: Bayer Clinical Trials Contact clinical-trials-contact@bayerhealthcare.com

Locations
Japan
Recruiting
Many locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co.LTD.
ClinicalTrials.gov Identifier: NCT01375998     History of Changes
Other Study ID Numbers: 15328, YAZ-DUI
Study First Received: June 8, 2011
Last Updated: April 18, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
YAZ
Dysmenorrhea

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Signs and Symptoms
 Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013