YAZ Post-marketing Surveillance in Japan

NCT01375998 | Completed

• 2 other identifiers: 15328YAZ-DUI
• Study Type: observational
• Target: 3,273
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dysmenorrhea

Keywords

YAZ; Dysmenorrhea

Outcome Measures

Primary Outcomes (2)

• Incidence of adverse drug reactions and sever adverse events

  During YAZ administration, up to 3 years

• Change from baseline in severity of dysmenorrhea at 6th cycles (28 days per cycle)

  Baseline and during YAZ administration, up to 3 years

Secondary Outcomes (5)

• Incidence of adverse events

  During YAZ administration, up to 3 years

• Unpleasant physical symptoms collection

  Baseline and during YAZ administration, up to 3 years

• Unpleasant psychological symptoms collection

  Baseline and during YAZ administration, up to 3 years

• Analgesic drug for dysmenorrhea

  During YAZ administration, up to 3 years

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

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

Study Arms (1)

Group 1

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

Interventions

EE20/DRSP(YAZ, BAY86-5300) DRUG

Patients in daily life treatment receiving YAZ for dysmenorrhea.

Group 1

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who received YAZ for dysmenorrhea Additional criteria for QOL questionnaire
• Patient informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Multiple Locations, Japan

Location

Related Publications (1)

• Momoeda M, Akiyama S, Tanaka K, Suzukamo Y. Quality of Life in Japanese Patients with Dysmenorrhea Treated with Ethinylestradiol 20 mug/Drospirenone 3 mg in a Real-World Setting: An Observational Study. Int J Womens Health. 2020 May 4;12:327-338. doi: 10.2147/IJWH.S238460. eCollection 2020.

  PMID: 32440228 DERIVED

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Dysmenorrhea

Condition Hierarchy (Ancestors)

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

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: June 20, 2011
• Study Start: June 9, 2011
• Primary Completion: December 5, 2017
• Study Completion: March 8, 2018
• Last Updated: March 7, 2019

Record last verified: 2019-03

Locations

JP (1)