Regulatory Post Marketing Surveillance Study on YAZ
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception; Premenstrual Syndrome; Acne
Intervention: EE20/DRSP (YAZ, BAY86-5300) (Drug)
Sponsored by: Bayer
Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
The objective of this Post Marketing Surveillance (PMS) is to gain information about safety
and efficacy in real practice.
Official title: Regulatory Post Marketing Surveillance Study on YAZ
Study design: Observational Model: Cohort, Time Perspective: Prospective
Adverse event collection
Release of Premenstrual Dysphoric Disorder (PMDD) or acne
Number of patients who used YAZ just for contraception
Number of patients who used YAZ for PMDD + contraception
Number of patients who used YAZ for Acne + contraception
Minimum age: 18 Years.
Maximum age: 50 Years.
- 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
- 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 and Contacts
Many Locations, Korea, Republic of
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Starting date: July 2009
Last updated: January 19, 2015