Efficacy and Safety Oral Contraceptive Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185484

308021

91353

Details and patient eligibility

About

The purpose of this study is to determine whether the study drug is effective in prevention of pregnancy in healthy women in reproductive age

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: 1,113 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy woman requesting contraception
• Age between 18 and 35 years (inclusive), smokers maximum age of 30 years (inclusive)

Exclusion criteria

• Any conditions might interfere study outcome

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,113 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: YAZ (DRSP 3 mg/EE 0.02 mg, BAY86-5300)