NCT00318799

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Bayer · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Pregnancy, Unplanned

Interventions

Type	Name	Description
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

Timeline

• Start date: 2006-04-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2006-04-27
• Last updated: 2013-11-25

Locations

1 site across 1 country: Netherlands