Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

Phase 2

Completed

• Conditions: Contraception
• Interventions: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K); Drug: SH D00264A (Triquilar)

• Registration Number: NCT00185224
• Lead Sponsor: Bayer

Brief Summary

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.

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.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-10
• Study First Submitted QC: 2005-09-10
• Study First Posted: 2005-09-16
• Study Completion: 2006-03
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1	EV/DNG (Qlaira, BAY86-5027, SH T00658K)	-
Arm 2	SH D00264A (Triquilar)	-

Primary Outcome Measures

Name	Time	Method
Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment	Baseline, Cycle 7

Secondary Outcome Measures

Name	Time	Method
Measurement of PK parameters	Cycle 4, Cycle 7

Trial Locations

Locations (1)

Bayer Schering Pharma AG - Clin. Pharm. Berlin; 🇩🇪 Berlin, Germany