We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
ClinicalTrials.gov Menu

Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00185224
Recruitment Status : Completed
First Posted : September 16, 2005
Last Update Posted : July 15, 2011
Information provided by:

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : March 2005
Actual Study Completion Date : March 2006

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

Primary Outcome Measures :
  1. Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment [ Time Frame: Baseline, Cycle 7 ]

Secondary Outcome Measures :
  1. Measurement of PK parameters [ Time Frame: Cycle 4, Cycle 7 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00185224

Layout table for location information
Bayer Schering Pharma AG - Clin. Pharm. Berlin
Berlin, Germany, 13342
Sponsors and Collaborators
Layout table for investigator information
Study Director: Bayer Study Director Bayer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00185224    
Other Study ID Numbers: 90927
EudraCT: 2004-001614-13
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptives, Oral, Hormonal
Contraceptive Agents, Hormonal
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Hormonal
Contraceptives, Postcoital
Contraceptives, Postcoital, Synthetic