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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.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00367276
Recruitment Status : Completed
First Posted : August 22, 2006
Last Update Posted : October 11, 2013
Information provided by (Responsible Party):

Tracking Information
First Submitted Date  ICMJE August 11, 2006
First Posted Date  ICMJE August 22, 2006
Last Update Posted Date October 11, 2013
Study Start Date  ICMJE December 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
Change of Psychological General Well Being Questionnaire score [ Time Frame: pretreatment cycle to cycle 6 ]
Original Primary Outcome Measures  ICMJE
 (submitted: August 21, 2006)
To assess the Quality of Life during treatment with an oral contraceptive containing Ethinylestradiol 30 μg and Drospirenone 3 mg.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2008)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 21, 2006)
To evaluate body composition pattern by MF-BIA from pre- treatment condition and change during treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE 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.
Official Title  ICMJE 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).
Brief Summary The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.
Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Healthy
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Arm 1
Intervention: Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2008)
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE May 2004
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00367276
Other Study ID Numbers  ICMJE 91070
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bayer
Study Sponsor  ICMJE Bayer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bayer Study Director Bayer
PRS Account Bayer
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP