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).

Bayer0 sites221 target enrollmentDecember 2002

ConditionsHealthy

InterventionsYasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)

DrugsYasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)

Overview

Phase: Phase 3
Intervention: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)
Conditions: Healthy
Sponsor: Bayer
Enrollment: 221
Primary Endpoint: Change of Psychological General Well Being Questionnaire score
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2002

End Date

May 2004

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Bayer

Responsible Party

Sponsor

Eligibility 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

Arms & Interventions

Arm 1

Intervention: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)

Outcomes

Primary Outcomes

Change of Psychological General Well Being Questionnaire score

Time Frame: pretreatment cycle to cycle 6

Secondary Outcomes

Changes in body composition (evaluated by Multifrequency Bioelectrical Impedance Analysis)(pretreatment to cycle 6)
Subject satisfaction with treatment at final visit(at final visit)
Subject evaluation of changes in greasy skin and greasy hair(baseline to cycle 6)