Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT00185224

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Contraception	Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K) Drug: SH D00264A (Triquilar)	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

58 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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

Study Start Date :

Mar 1, 2005

Actual Study Completion Date :

Mar 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1	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
Active Comparator: Arm 2	Drug: 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

Arm

Intervention/Treatment

Experimental: Arm 1

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

Active Comparator: Arm 2

Drug: 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

Outcome Measures

Primary Outcome Measures

Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment [Baseline, Cycle 7]

Secondary Outcome Measures

Measurement of PK parameters [Cycle 4, Cycle 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Bayer Schering Pharma AG - Clin. Pharm. Berlin	Berlin		Germany	13342

Sponsors and Collaborators

Bayer

Investigators

Study Director: Bayer Study Director, Bayer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00185224

Other Study ID Numbers:

90927
EudraCT: 2004-001614-13
301886

First Posted:

Sep 16, 2005

Last Update Posted:

Jul 15, 2011

Last Verified:

Jul 1, 2011

Additional relevant MeSH terms:

Ethinyl Estradiol-Norgestrel Combination

Study Results

No Results Posted as of Jul 15, 2011