Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters

Overview

The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

Full Title of Study: “A Single-centre, Open-label, Crossover, Controlled, Randomized Study to Investigate the Impact of SH T00658ID as Compared to a Monophasic Contraceptive Containing Ethinylestradiol and Levonorgestrel (SH D01155E) on Hemostatic Parameters in 30 Healthy Female Volunteers Over 3 Treatment Cycles”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2007

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.

Interventions

  • Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID)
    • per cycle (28 days): Days 1-2: 3.0 mg EV; Days 3-7: 2.0 mg EV + 2.0 mg DNG; Days 824: 2.0 mg EV + 3.0 mg DNG; Days 25-26: 1.0 mg EV; Days 27-28: Placebo
  • Drug: SH D01155E
    • per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo

Arms, Groups and Cohorts

  • Experimental: Arm 1
  • Active Comparator: Arm 2

Clinical Trial Outcome Measures

Primary Measures

  • Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover
    • Time Frame: Baseline, Cycle 3 of each treatment period

Secondary Measures

  • Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II).
    • Time Frame: Baseline, Cycle 3 of each treatment period
  • Adverse events
    • Time Frame: 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy female volunteers Exclusion Criteria:

  • Pregnancy or lactation – Any condition that might interfere with the outcome as all contraindications for OC use.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

Citations Reporting on Results

Klipping C, Duijkers I, Parke S, Mellinger U, Serrani M, Junge W. Hemostatic effects of a novel estradiol-based oral contraceptive: an open-label, randomized, crossover study of estradiol valerate/dienogest versus ethinylestradiol/levonorgestrel. Drugs R D. 2011;11(2):159-70. doi: 10.2165/11591200-000000000-00000.

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