Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

Verified by: Bayer, May 2009
First Received: February 18, 2008 | Last Updated: May 28, 2009 | Phase: Phase 3 | Start Date: March 2004
Overall Status: Completed | Estimated Enrollment: 440
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The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator...

Brief Summary

Official Title: “Open, Randomized, Parallel Multi-Center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-Day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers”

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Intervention(s) in this Clinical Trial

  • Drug: Yasmin 20
    • Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
  • Drug: Mercilon
    • Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: Arm 1
  • Active Comparator: Arm 2

Outcome Measures for this Clinical Trial

Primary Measures

  • Cycle control and bleeding pattern
    • Time Frame: 7 cycles
      Safety Issue?: No

Secondary Measures

  • Pearl index
    • Time Frame: 7 cycles
      Safety Issue?: No
  • Laboratory tests
    • Time Frame: Screening
      Safety Issue?: Yes
  • Adverse Events
    • Time Frame: 7 cycles
      Safety Issue?: Yes
  • General Physical and gynecological examinations
    • Time Frame: Screening
      Safety Issue?: Yes
  • Vital signs
    • Time Frame: Screening, admission
      Safety Issue?: Yes
  • Body weight
    • Time Frame: Screening, admission
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Healthy female volunteer aged 18-35,
  • Smokers 18-30

Exclusion Criteria:

  • Contraindications for using hormonal contraceptives

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 35 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Bayer Industry

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00624130

Study ID Number: 91352

ClinicalTrials.gov Identifier: NCT00624130

Health Authority: Finland: Finnish Medicines Agency

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