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

September 10, 2005
July 14, 2011
March 2005
Not Provided
Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment [ Time Frame: Baseline, Cycle 7 ]
Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment
Complete list of historical versions of study NCT00185224 on ClinicalTrials.gov Archive Site
Measurement of PK parameters [ Time Frame: Cycle 4, Cycle 7 ]
Measurement of PK parameters
Not Provided
Not Provided
 
Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive
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

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Contraception
  • 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
  • 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
  • Experimental: Arm 1
    Intervention: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)
  • Active Comparator: Arm 2
    Intervention: Drug: SH D00264A (Triquilar)
Junge W, Mellinger U, Parke S, Serrani M. Metabolic and haemostatic effects of estradiol valerate/dienogest, a novel oral contraceptive: a randomized, open-label, single-centre study. Clin Drug Investig. 2011;31(8):573-84.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
March 2006
Not Provided

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
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00185224
90927, EudraCT: 2004-001614-13, 301886
Not Provided
Therapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP