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Regulatory Post Marketing Surveillance Study on YAZ

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00998257
First Posted: October 20, 2009
Last Update Posted: January 21, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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:


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) ]
  • Contraception efficacy [ Time Frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) ]
  • Drug compliance [ Time Frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) ]
  • Release of Premenstrual Dysphoric Disorder (PMDD) or acne [ Time Frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days) ]

Secondary Outcome Measures:
  • Number of patients who used YAZ just for contraception [ Time Frame: At initial visit (Day 0) ]
  • Number of patients who used YAZ for PMDD + contraception [ Time Frame: At initial visit (Day 0) ]
  • Number of patients who used YAZ for Acne + contraception [ Time Frame: At initial visit (Day 0) ]

Biospecimen Retention:   None Retained
n.a

Enrollment: 770
Study Start Date: July 2009
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00998257     History of Changes
Other Study ID Numbers: 14785
YA0910KR ( Other Identifier: company internal )
YAZ rPMS ( Other Identifier: company internal )
First Submitted: September 21, 2009
First Posted: October 20, 2009
Last Update Posted: January 21, 2015
Last Verified: January 2015

Keywords provided by Bayer:
Contraception
Premenstrual Dysphoric Disorder
PMDD
Acne

Additional relevant MeSH terms:
Premenstrual Syndrome
Menstruation Disturbances
Pathologic Processes