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Completed

NCT Number: NCT00318799

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

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.

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Key information

Conditions

Pregnancy, Unplanned

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Dinox B.V.

Groningen, 9713GZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy female volunteers

Exclusion criteria

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

Treatment and study plan

EV/DNG (Qlaira, BAY86-5027, SH T00658ID)

Drug

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

SH D01155E

Drug

per cycle: Days 1-21: 0.03 mg EE + 0.15 mg LNG; Days 22-28: Placebo

Primary outcomes

  1. Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover

    Time frame: Baseline, Cycle 3 of each treatment period

Secondary outcomes

  1. 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

  2. Adverse events

    Time frame: 2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Apr 27, 2006
Registry last updated
Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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