Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers

Phase 3

Completed

• Conditions: Contraception
• Interventions: Drug: Yasmin 20; Drug: Mercilon

• Registration Number: NCT00624130
• Lead Sponsor: Bayer

Brief Summary

The purpose of this study is to compare bleeding pattern of contraceptive Yasmin 20 to a marketed comparator.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2005-06
• Study First Submitted: 2008-02-18
• Study First Submitted QC: 2008-02-25
• Study First Posted: 2008-02-26
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-30
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 453

Inclusion Criteria

• Healthy female volunteer aged 18-35,
• Smokers 18-30

Exclusion Criteria

• Contraindications for using hormonal contraceptives

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	Yasmin 20	-
Arm 2	Mercilon	-

Primary Outcome Measures

Name	Time	Method
Cycle control and bleeding pattern	7 cycles

Secondary Outcome Measures

Name	Time	Method
Body weight	Screening, admission
Vital signs	Screening, admission
Laboratory tests	Screening
Adverse Events	7 cycles
General Physical and gynecological examinations	Screening
Pearl index	7 cycles