Yasmin 20 Cycle Control - Yasmin 20 Versus Mercilon in Healthy Female Volunteers - Full Text View

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00624130

Purpose

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

Condition	Intervention	Phase
Contraception	Drug: Yasmin 20 Drug: Mercilon	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Open, Randomized, Parallel Multi-Center Comparison of Cycle Control and Safety of the Oral Contraceptive Yasmin 20 in a 24-Day Regimen vs. Mercilon for 7 Cycles in 440 Healthy Female Volunteers

Resource links provided by NLM:

MedlinePlus related topics: Birth Control

Drug Information available for: Dacuronium bromide Dacuronium

Further study details as provided by Bayer:

Primary Outcome Measures:

Cycle control and bleeding pattern [ Time Frame: 7 cycles ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pearl index [ Time Frame: 7 cycles ] [ Designated as safety issue: No ]
Laboratory tests [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
Adverse Events [ Time Frame: 7 cycles ] [ Designated as safety issue: Yes ]
General Physical and gynecological examinations [ Time Frame: Screening ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: Screening, admission ] [ Designated as safety issue: Yes ]
Body weight [ Time Frame: Screening, admission ] [ Designated as safety issue: Yes ]

Arms	Assigned Interventions
Arm 1: Experimental	Drug: Yasmin 20 Yasmin 20, 24-d regimen vs Mercilon, Tablet p.o. (oral)
Arm 2: Active Comparator	Drug: Mercilon Mercilon, 24-d regimen vs Yasmin 20 , Tablet p.o. (oral)

Eligibility

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00624130

Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

No publications provided

Responsible Party:	Bayer Schering Pharma AG ( Therapeutic Area Head )
Study ID Numbers:	91352, 308020
Study First Received:	February 18, 2008
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00624130 History of Changes
Health Authority:	Finland: Finnish Medicines Agency; Estonia: The State Agency of Medicine; Lithuania: State Medicine Control Agency - Ministry of Health; Austria: Federal Ministry for Health and Women; United States: Institutional Review Board

Keywords provided by Bayer:

Contraception,
Cycle control,
Bleeding pattern

ClinicalTrials.gov processed this record on February 08, 2010