Trial Condition(s):

Contraception, Premenstrual Syndrome, Acne

Regulatory Post marketing Surveillance Study on YAZ

Bayer Identifier:

14785

ClinicalTrials.gov Identifier:

NCT00998257

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

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

Trial Summary

Enrollment Goal
770
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
YAZ (EE20/DRSP, BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, South Korea

Status
Completed
 

Trial Design