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Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00185224
First received: September 10, 2005
Last updated: July 14, 2011
Last verified: July 2011
History of Changes
  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: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
Drug: SH D00264A (Triquilar)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Birth Control
U.S. FDA Resources

Further study details as provided by Bayer:

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

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

Enrollment: 58
Study Start Date: March 2005
Study Completion Date: March 2006
Arms Assigned Interventions
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

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
Accepts Healthy Volunteers:   Yes
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

Locations
Germany
Bayer Schering Pharma AG - Clin. Pharm. Berlin
Berlin, Germany, 13342
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Therapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00185224     History of Changes
Other Study ID Numbers: 90927, EudraCT: 2004-001614-13, 301886
Study First Received: September 10, 2005
Last Updated: July 14, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: LAG-Landesamt für Arbeitsschutz, Gesundheitsschutz und Technische Sicherheit Berlin

Additional relevant MeSH terms:
Contraceptive Agents
Ethinyl Estradiol-Norgestrel Combination
Contraceptives, Oral
Contraceptives, Oral, Sequential
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Contraceptive Agents, Female
Contraceptives, Oral, Combined
Contraceptives, Oral, Synthetic
Contraceptives, Postcoital, Synthetic
Contraceptives, Postcoital

ClinicalTrials.gov processed this record on May 16, 2013