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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)

Phase: N/A

Status: Completed

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Summary

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

Clinical Details

Official title: Regulatory Post Marketing Surveillance Study on YAZ

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome:

Adverse event collection

Contraception efficacy

Drug compliance

Release of Premenstrual Dysphoric Disorder (PMDD) or acne

Secondary outcome:

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

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Female.

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

Locations and Contacts

Many Locations, Korea, Republic of
Additional Information

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Click here to find results for studies related to Bayer Healthcare products.

Starting date: July 2009
Last updated: January 19, 2015

Page last updated: August 23, 2015

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