Regulatory Post Marketing Surveillance Study on YAZ

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer

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