Trial Condition(s):
Healthy
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.
Bayer Identifier:
91070
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.
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
Trial Summary
Enrollment Goal
221
Trial Dates
Phase
3
Could I receive a placebo?
No
Products
Yasmin (EE30/DRSP, BAY86-5131)
Accepts Healthy Volunteers
No
Where to Participate
Locations
| Locations |
|---|
Trial Design
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).
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Change of Psychological General Well Being Questionnaire scoreTimeframe: pretreatment cycle to cycle 6
Secondary Outcome
- Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)Timeframe: pretreatment to cycle 6
- Subject satisfaction with treatment at final visitTimeframe: at final visit
- Subject evaluation of changes in greasy skin and greasy hairTimeframe: baseline to cycle 6
Additional Information
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