- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00367276
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.
October 10, 2013 updated by: Bayer
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 Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
221
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm 1
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change of Psychological General Well Being Questionnaire score
Time Frame: pretreatment cycle to cycle 6
|
pretreatment cycle to cycle 6
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)
Time Frame: pretreatment to cycle 6
|
pretreatment to cycle 6
|
Subject satisfaction with treatment at final visit
Time Frame: at final visit
|
at final visit
|
Subject evaluation of changes in greasy skin and greasy hair
Time Frame: baseline to cycle 6
|
baseline to cycle 6
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2002
Study Completion (Actual)
May 1, 2004
Study Registration Dates
First Submitted
August 11, 2006
First Submitted That Met QC Criteria
August 21, 2006
First Posted (Estimate)
August 22, 2006
Study Record Updates
Last Update Posted (Estimate)
October 11, 2013
Last Update Submitted That Met QC Criteria
October 10, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 91070
- 305545
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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