Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive - Full Text View

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00185224

Purpose

The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.

Condition	Intervention	Phase
Contraception	Drug: SH T00658ID	Phase II

Drug Information available for: Ethinyl estradiol Levonorgestrel Lipids

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	A Single-Center, Open-Label, Controlled, Randomized Study to Investigate the Impact of a Sequential Oral Contraceptive (SH T00658ID) as Compared to a Sequential Oral Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D00264A) on Plasma Lipids, Hemostatic Variables, and Carbohydrate Metabolism in Healthy Female Volunteers Aged 18-50 Years Over 7 Treatment Cycles, Including the Pharmacokinetics

Further study details as provided by Bayer:

Primary Outcome Measures:

Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment

Secondary Outcome Measures:

Measurement of PK parameters

Study Start Date:	March 2005
Estimated Study Completion Date:	June 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

Criteria

Inclusion Criteria:

Healthy female volunteers 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: NCT00185224

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Schering Pharma AG, Germany, Medical Affairs

T. +49 30 468 11800

More Information

Study ID Numbers:	301886
Study First Received:	September 10, 2005
Last Updated:	April 30, 2007
ClinicalTrials.gov Identifier:	NCT00185224
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; Germany: LAGetSi – Landesamt für Arbeitsschutz, Gesundheitsschutz und Technische Sicherheit Berlin

Study placed in the following topic categories:

Levonorgestrel
Ethinyl Estradiol
Healthy

ClinicalTrials.gov processed this record on January 14, 2009