Study to Evaluate the Effect of Six Cycles of Treatment With a Combined Oral Contraceptive (EE 0.30 mg/DRSP 3 mg) on Quality of Life.

Verified by: Bayer, July 2009
First Received: August 11, 2006 | Last Updated: July 6, 2009 | Phase: Phase 3 | Start Date: December 2003
Overall Status: Completed | Estimated Enrollment: 221
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The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives...

Brief Summary

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: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Detailed Clinical Trial Description

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

Outcome Measures for this Clinical Trial

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

Criteria for Participation in this Clinical Trial

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

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/NCT00367276

Study ID Number: 91070

ClinicalTrials.gov Identifier: NCT00367276

Health Authority: Italy: Ethics Committee

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00367276