Effects of Drospirenone-containing or -Not Containing Combined Oral Contraceptives on General and Sexual Well-being

Completed

• Conditions: Contraception
• Interventions: Drug: Other combined oral contraceptives; Drug: EE30-DRSP (Yasmin, BAY86-5131)

• Registration Number: NCT00988910
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to evaluate the symptoms and satisfaction for women taking drospirenone (DRSP)-containing combined oral contraceptives in comparison with women taking other kind of combined oral contraceptives.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2009-10-01
• Study First Submitted QC: 2009-10-01
• Study First Posted: 2009-10-02
• Primary Completion: 2009-12
• Study Completion: 2010-12
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-25
• Last Update Posted: 2014-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 632

Inclusion Criteria

• According to the label of the prescribed Combined Oral Contraceptive (COC)
• first Combined Oral Contraceptive use or previous Combined Oral Contraceptive use
• intention to use current COC for 1 year at least

Exclusion Criteria

• Contraindications listed in the label of the prescribed Combined Oral Contraceptive (COC)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Other combined oral contraceptives	-
Group 1	EE30-DRSP (Yasmin, BAY86-5131)	-

Primary Outcome Measures

Name	Time	Method
Sexual well-being evaluated by the Female Sexual Function Index (FSFI)	at 12 months
Psychophysical well-being evaluated by the Psychological General Well-Being Index (PGWBI)	at 12 months