Study to Investigate Efficacy and Safety of a New Oral Contraceptive

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185289

91191

EudraCT: 2004-002098-22

306660

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and effectiveness of a new 4-phasic preparation in the prevention of pregnancies in a large group of volunteers.

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: 1,392 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers

Exclusion criteria

• Any condition that might interfere the outcomes

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,392 participants in 1 patient group

Arm 1

Experimental group

Treatment:

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