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Completed

NCT Number: NCT01375998

YAZ Post-marketing Surveillance in Japan

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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Key information

Conditions

Dysmenorrhea Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Sex eligibility

Female

Study type

Observational

Primary location

Multiple Locations, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EE20/DRSP(YAZ, BAY86-5300)

Drug

Patients in daily life treatment receiving YAZ for dysmenorrhea.

Primary outcomes

  1. Incidence of adverse drug reactions and sever adverse events

    Time frame: During YAZ administration, up to 3 years

  2. 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

Secondary outcomes

  1. Incidence of adverse events

    Time frame: During YAZ administration, up to 3 years

  2. Unpleasant physical symptoms collection

    Time frame: Baseline and during YAZ administration, up to 3 years

  3. Unpleasant psychological symptoms collection

    Time frame: Baseline and during YAZ administration, up to 3 years

  4. Analgesic drug for dysmenorrhea

    Time frame: During YAZ administration, up to 3 years

  5. QOL survey using Short-Form 36-Item Health Survey (SF-36)

    Time frame: Baseline and at 6th - 8th cycles (28 datys per cycle)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Drug Use Investigation of YAZ

Important dates

Study start
2011
Primary completion
2017
Study completion
2018
First posted
Jun 20, 2011
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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