Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

Contraception Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00185224
• Other study ID #: 90927
• Secondary ID: EudraCT: 2004-00
• Status: Completed
• Phase: Phase 2
• First received: September 10, 2005
• Last updated: July 14, 2011
• Start date: March 2005
• Est. completion date: March 2006

Study information

• Verified date: July 2011
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesGermany: LAG-Landesamt für Arbeitsschutz, Gesundheitsschutz und Technische Sicherheit Berlin
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: March 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• EV/DNG (Qlaira, BAY86-5027, SH T00658K)
7 treatment cycles of 28 days each (no tablet-free intervals); Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 8-24: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27 - 28: Placebo
• SH D00264A (Triquilar)
7 treatment cycles of 28 days each (no tablet-free intervals);Days 1-6: 0.03 mg EE + 0.05 mg LNG; Days 7-11: 0.04 mg EE + 0.075 mg LNG; Days 12-21: 0.03 mg EE + 0.125 mg LNG;Days 22-28: Placebo

Locations

Country	Name	City	State
Germany	Bayer Schering Pharma AG - Clin. Pharm. Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment		Baseline, Cycle 7
Secondary	Measurement of PK parameters		Cycle 4, Cycle 7

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