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.

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)

• Registration Number: NCT00367276
• Lead Sponsor: Bayer

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.

Study Timeline

• Study Start: 2002-12
• Study Completion: 2004-05
• Study First Submitted: 2006-08-11
• Study First Submitted QC: 2006-08-21
• Study First Posted: 2006-08-22
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-10
• Last Update Posted: 2013-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 221

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm 1	Yasmin (30 µg EE, 3 mg Drospirenone, BAY86-5131)	-

Primary Outcome Measures

Name	Time	Method
Change of Psychological General Well Being Questionnaire score	pretreatment cycle to cycle 6

Secondary Outcome Measures

Name	Time	Method
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