FC Patch Comparator Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: BAY86-5016, SH P00331F; Drug: SH P00331N

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185354

2004-000821-31 (EudraCT Number)

307969 (Other Identifier)

91402

Details and patient eligibility

About

The purpose of this study is to compare bleeding pattern and safety of contraceptive patch SH P00331F to a marketed comparator.

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: 422 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female volunteer aged 18-35, smokers 18-30

Exclusion criteria

• Contraindications for using hormonal contraceptives

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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422 participants in 2 patient groups

Arm 1

Experimental group

Treatment:

Drug: BAY86-5016, SH P00331F

Arm 2

Active Comparator group

Treatment:

Drug: SH P00331N