Trial Condition(s):
Regulatory Post marketing Surveillance Study on YAZ
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Not Available
Not Available
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice.
- 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
- 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
Locations | |
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Locations Investigative Site Many Locations, South Korea | Contact Us: E-mail: [email protected] Phone: Not Available |
Regulatory Post marketing Surveillance Study on YAZ
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1