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OpenTrials
Completed

NCT Number: NCT00998257

Regulatory Post Marketing Surveillance Study on YAZ

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EE20/DRSP (YAZ, BAY86-5300)

Drug

Patients under daily life treatment with YAZ according to local drug information.

Primary outcomes

  1. Adverse event collection

    Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

  2. Contraception efficacy

    Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

  3. Drug compliance

    Time frame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

  4. 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 outcomes

  1. Number of patients who used YAZ just for contraception

    Time frame: At initial visit (Day 0)

  2. Number of patients who used YAZ for PMDD + contraception

    Time frame: At initial visit (Day 0)

  3. Number of patients who used YAZ for Acne + contraception

    Time frame: At initial visit (Day 0)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2009
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.