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.
Information source: Bayer
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Healthy
Intervention: Yasmin, 30 µg ethinylestradiol and 3 mg drospirenone (DRSP) (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer
Summary
The purpose of this study is to evaluate the effects on the quality of life and BMI of new
contraceptives.
Clinical Details
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).
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change of Psychological General Well Being Questionnaire score
Secondary outcome: Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)Subject satisfaction with treatment at final visit Subject evaluation of changes in greasy skin and greasy hair
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
Criteria:
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
Locations and Contacts
Additional Information
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Starting date: December 2003
Ending date: May 2004
Last updated: April 29, 2008
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