check_circleStudy Completed
Healthy
Bayer Identifier:
91070
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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.
Trial purpose
The purpose of this study is to evaluate the effects on the quality of life and BMI of new contraceptives.
Key Participants Requirements
Sex
FemaleAge
18 - 35 YearsTrial summary
Enrollment Goal
221Trial Dates
December 2002 - May 2004Phase
Phase 3Could I Receive a placebo
NoProducts
Yasmin (EE30/DRSP, BAY86-5131)Accepts Healthy Volunteer
NoPrimary Outcome
- Change of Psychological General Well Being Questionnaire scoredate_rangeTime Frame:pretreatment cycle to cycle 6enhanced_encryptionNoneSafety Issue:
Secondary Outcome
- Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)date_rangeTime Frame:pretreatment to cycle 6enhanced_encryptionNoneSafety Issue:
- Subject satisfaction with treatment at final visitdate_rangeTime Frame:at final visitenhanced_encryptionNoneSafety Issue:
- Subject evaluation of changes in greasy skin and greasy hairdate_rangeTime Frame:baseline to cycle 6enhanced_encryptionNoneSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1