Status:
COMPLETED
Regulatory Post Marketing Surveillance Study on YAZ
Lead Sponsor:
Bayer
Conditions:
Contraception
Premenstrual Syndrome
Eligibility:
FEMALE
18-50 years
Brief Summary
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
770 Patients enrolled
Trial Details
Trial ID
NCT00998257
Start Date
July 1 2009
End Date
November 1 2011
Last Update
January 21 2015
Active Locations (1)
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1
Many Locations, South Korea