Regulatory Post Marketing Surveillance Study on YAZ

Bayer

Status: Completed

Conditions: Acne; Contraception; Premenstrual Syndrome

Treatments: Drug: EE20/DRSP (YAZ, BAY86-5300)

Study type: Observational

Funder types: Industry

Identifiers

NCT00998257

14785

YAZ rPMS (Other Identifier)

YA0910KR (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 770 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

770 participants in 1 patient group

Group 1

Treatment:

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