Comparative Cycle Control Europe

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: SH D 593 B (Miranova); Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185367

EudraCT: 2004-001613-34

304004

90883

Details and patient eligibility

About

The aim of this study is to evaluate bleeding pattern, cycle control, and safety of this new four-phasic oral contraceptive in comparison to a reference OC.

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: 798 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female volunteers aged between 18 and 50 years requiring contraception

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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798 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K)

Arm 2

Active Comparator group

Treatment:

Drug: SH D 593 B (Miranova)