Regulatory Post Marketing Surveillance Study on YAZ

Completed

• Conditions: Contraception; Premenstrual Syndrome; Acne
• Interventions: Drug: EE20/DRSP (YAZ, BAY86-5300)

• Registration Number: NCT00998257
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-09-21
• Study First Submitted QC: 2009-10-19
• Study First Posted: 2009-10-20
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-19
• Last Update Posted: 2015-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 770

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	EE20/DRSP (YAZ, BAY86-5300)	-

Primary Outcome Measures

Name	Time	Method
Release of Premenstrual Dysphoric Disorder (PMDD) or acne	After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Contraception efficacy	After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Adverse event collection	After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)
Drug compliance	After taking YAZ for 3 cycles and 6 cycles (1 cycle is 28 days)

Secondary Outcome Measures

Name	Time	Method
Number of patients who used YAZ just for contraception	At initial visit (Day 0)
Number of patients who used YAZ for Acne + contraception	At initial visit (Day 0)
Number of patients who used YAZ for PMDD + contraception	At initial visit (Day 0)