Bleeding Pattern Study

Bayer

Status and phase: Completed; Phase 3

Conditions: Oral Contraceptive

Treatments: Drug: Valette (Dienogest/EE30, BAY86-5038)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00302666

306903

91227

Details and patient eligibility

About

The aim of this study is to evaluate bleeding pattern, cycle control, contraceptive efficacy and safety of this oral contraceptive in two different regimens of intake.

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: 1,315 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female volunteers aged between 18 and 40 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: None (Open label)

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1,315 participants in 2 patient groups

Arm 1

Sham Comparator group

Treatment:

Drug: Valette (Dienogest/EE30, BAY86-5038)

Drug: Valette (Dienogest/EE30, BAY86-5038)

Arm 2

Sham Comparator group

Treatment:

Drug: Valette (Dienogest/EE30, BAY86-5038)

Drug: Valette (Dienogest/EE30, BAY86-5038)