Clinical trial NCT00998257: Regulatory Post Marketing Surveillance Study on YAZ
Official title: Regulatory Post Marketing Surveillance Study on YAZ
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Premenstrual Syndrome
Acne
Keywords: Contraception
Premenstrual Dysphoric Disorder
PMDD
Acne
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-10-20
Enrollment: 770
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility 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

Primary outcomes:
measure: Adverse event collection
timeFrame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
measure: Contraception efficacy
timeFrame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
measure: Drug compliance
timeFrame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
measure: Release of Premenstrual Dysphoric Disorder (PMDD) or acne
timeFrame: After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Secondary outcomes:
measure: Number of patients who used YAZ just for contraception
timeFrame: At initial visit (Day 0)
measure: Number of patients who used YAZ for PMDD + contraception
timeFrame: At initial visit (Day 0)
measure: Number of patients who used YAZ for Acne + contraception
timeFrame: At initial visit (Day 0)
Other outcomes:
Locations:
city: Many Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: