Regulatory Post Marketing Surveillance Study on YAZ - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00998257

Purpose

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

Condition	Intervention
Contraception Premenstrual Syndrome Acne	Drug: EE20/DRSP (YAZ, BAY86-5300)

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Regulatory Post Marketing Surveillance Study on YAZ

Resource links provided by NLM:

MedlinePlus related topics: Acne Birth Control Premenstrual Syndrome

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

Adverse event collection [ Time Frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) ] [ Designated as safety issue: Yes ]
Contraception efficacy [ Time Frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) ] [ Designated as safety issue: No ]
Drug compliance [ Time Frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) ] [ Designated as safety issue: No ]
Release of Premenstrual Dysphoric Disorder (PMDD) or acne [ Time Frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Number of patients who used YAZ just for contraception [ Time Frame: At initial visit (Day 0) ] [ Designated as safety issue: No ]
Number of patients who used YAZ for PMDD + contraception [ Time Frame: At initial visit (Day 0) ] [ Designated as safety issue: No ]
Number of patients who used YAZ for Acne + contraception [ Time Frame: At initial visit (Day 0) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

n.a

Enrollment:	770
Study Start Date:	July 2009
Study Completion Date:	November 2011

Groups/Cohorts	Assigned Interventions
Group 1	Drug: EE20/DRSP (YAZ, BAY86-5300) Patients under daily life treatment with YAZ according to local drug information.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Korean female who need only contraception or contraception and management of PMDD or contraception and treatment of acne.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00998257

Locations

Korea, Republic of

Many Locations, Korea, Republic of

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

Click here and search for drug information provided by the FDA. This link exits the ClinicalTrials.gov site

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

No publications provided

Responsible Party:	Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier:	NCT00998257 History of Changes
Other Study ID Numbers:	14785, YA0910KR, YAZ rPMS
Study First Received:	September 21, 2009
Last Updated:	May 22, 2012
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:

Contraception
Premenstrual Dysphoric Disorder
PMDD
Acne

Additional relevant MeSH terms:

Acne Vulgaris
Premenstrual Syndrome
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Menstruation Disturbances

Pathologic Processes
Drospirenone and ethinyl estradiol combination
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2012