Cycle Control Study - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185367

Purpose

The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

Condition	Intervention	Phase
Contraception	Drug: SH T00658ID	Phase III

Drug Information available for: Ethinyl estradiol Levonorgestrel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Double-Blind, Double-Dummy, Controlled, Randomized Study to Evaluate Cycle Control and Safety of a Four Phasic Oral Contraceptive (SH T00658ID) in Comparison to an Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D 593 B) in Healthy Female Volunteers Aged Between 18 and 50 Years.

Further study details as provided by Bayer:

Primary Outcome Measures:

Bleeding pattern
Number of unintended pregnancies

Secondary Outcome Measures:

Adverse events

Study Start Date:	March 2005
Estimated Study Completion Date:	September 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy female volunteers aged between 18 and 50 years requiring contraception.

Exclusion Criteria:

Pregnancy or lactation.
Any conditions that might interfere with the outcome as well as all contraindications for OC use.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00185367

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

T. +49 30 468 11800

More Information

Study ID Numbers:	304004
Study First Received:	September 13, 2005
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00185367
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Czech Republic: SUKL, STÁTNĺ ÚSTAV PRO KONTROLU LÉČIV; France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Levonorgestrel
Ethinyl Estradiol
Healthy

ClinicalTrials.gov processed this record on January 14, 2009