Regulatory Post Marketing Surveillance Study on YAZ

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

Official Title
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Regulatory Post Marketing Surveillance Study on YAZ

Conditions
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Contraception, Premenstrual Syndrome, Acne

Intervention / Treatment
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* Drug: EE20/DRSP (YAZ, BAY86-5300)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: EE20/DRSP (YAZ, BAY86-5300)<br>* Patients under daily life treatment with YAZ according to local drug information.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event collection |  | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) | 
| Contraception efficacy |  | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) | 
| Drug compliance |  | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) | 
| Release of Premenstrual Dysphoric Disorder (PMDD) or acne |  | After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who used YAZ just for contraception |  | At initial visit (Day 0) | 
| Number of patients who used YAZ for PMDD + contraception |  | At initial visit (Day 0) | 
| Number of patients who used YAZ for Acne + contraception |  | At initial visit (Day 0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contraception, Premenstrual Dysphoric Disorder, PMDD, Acne