Official Title: “A Multicentre, Open, Uncontrolled Study to Assess Quality of Life During Six Cycles (24 Weeks) of Treatment With an Oral Contraceptive Containing 30 µg of Ethinylestradiol and 3 mg of Drospirenone (Yasmin).”

The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Intervention(s) in this Clinical Trial

• Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)
  • Yasmin, SH T 470 FA; 30 µg ethinylestradiol and 3 mg drospirenone, oral administration over 6 treatment cycles, one tablet per day for 21 days followed by a 7 day pill-free interval.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1

Primary Measures

• Change of Psychological General Well Being Questionnaire score
  • Time Frame: pretreatment cycle to cycle 6
    

Secondary Measures

• Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)
  • Time Frame: pretreatment to cycle 6
    
• Subject satisfaction with treatment at final visit
  • Time Frame: at final visit
    
• Subject evaluation of changes in greasy skin and greasy hair
  • Time Frame: baseline to cycle 6
    

Inclusion Criteria:

• Female requiring contraceptives.
• Aged 18 to 35 if a non-smoker, aged 18 to 30 if a smoker.
• Regular menstrual cycle (defined as duration of 28 +/- 5 days).

Exclusion Criteria:

• No Contraindication for OC use

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?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00367276

Study ID Number: 91070

ClinicalTrials.gov Identifier: NCT00367276

Health Authority: Italy: Ethics Committee

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