Regulatory Post Marketing Surveillance Study on YAZ

NCT ID: NCT00998257

Last Updated: 2015-01-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 770 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2011-11-30

Brief Summary

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.

Conditions

Contraception; Premenstrual Syndrome; Acne

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group 1

EE20/DRSP (YAZ, BAY86-5300)

Intervention Type: DRUG

Patients under daily life treatment with YAZ according to local drug information.

Interventions

EE20/DRSP (YAZ, BAY86-5300)

Patients under daily life treatment with YAZ according to local drug information.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy female subjects

• requesting contraception
• suggesting PMDD by Physician who are also requesting contraception
• with acne who are also requesting contraception
• Age: 18 - 50 years
• Women who is prescribed YAZ first, during study period

Exclusion Criteria

• Women who are contraindicated based on the label of YAZ

• Presence or a history of venous or arterial thrombotic/ thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident
• Presence or history of prodromi of a thrombosis (e.g. transient ischaemic attack, angina pectoris)
• History of migraine with focal neurological symptoms
• Diabetes mellitus with vascular involvement
• The presence of a severe or multiple risk factor(s) for venous or arterial thrombosis may also constitute a contraindication
• Pancreatitis or a history thereof if associated with severe hypertriglyceridemia
• Presence or history of severe hepatic disease as long as liver function values have not returned to normal
• Severe renal insufficiency or acute renal failure
• Presence or history of liver tumours (benign or malignant)
• Known or suspected sex-steroid influenced malignancies (e.g. of the genital organs or the breasts)
• Undiagnosed vaginal bleeding
• Known or suspected pregnancy
• Hypersensitivity to the active substances or to any of the excipients

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

Many Locations, , South Korea

Countries

South Korea

Other Identifiers

YA0910KR

Identifier Type: OTHER

Identifier Source: secondary_id

YAZ rPMS

Identifier Type: OTHER

Identifier Source: secondary_id

14785

Identifier Type: -

Identifier Source: org_study_id