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

Bayer

Status and phase: Completed; Phase 2

Conditions: Pregnancy, Unplanned

Treatments: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658ID); Drug: SH D01155E

Study type: Interventional

Funder types: Industry

Identifiers

NCT00318799

310122 (Other Identifier)

91477

2005-004688-45 (EudraCT Number)

Details and patient eligibility

About

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 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.

Enrollment: 29 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female volunteers

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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29 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

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

Arm 2

Active Comparator group

Treatment:

Drug: SH D01155E