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: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study

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
  • n/a
• Active Comparator: Arm 2
  • n/a

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

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

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on September 05, 2008

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

Study ID Number: 91352

ClinicalTrials.gov Identifier: NCT00624130

Health Authority: Finland: National Agency for Medicines

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Click here to find results for studies related to marketed products