CompletedPhase 2

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

Netherlands29 participantsStarted 2006-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion Criteria: * Healthy female volunteers Exclusion Criteria: * Pregnancy or lactation * Any condition that might interfere with the outcome as all contraindications for OC use.

What they're measuring

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

Timeframe: Baseline, Cycle 3 of each treatment period

Trial details

NCT IDNCT00318799

SponsorBayer

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-05

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