Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

Bayer

Status and phase: Completed; Phase 2

Conditions: Contraception

Treatments: Drug: EV/DNG (Qlaira, BAY86-5027, SH T00658K); Drug: SH D00264A (Triquilar)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185224

90927

301886

EudraCT: 2004-001614-13

Details and patient eligibility

About

The purpose of this study is to confirm the safety of SH T00658ID with regard to plasma lipids, hemostatic variables, and carbohydrate metabolism. In addition, the pharmacokinetic parameter following the long term administration of SH T00658ID will be assessed.

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: 58 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy female volunteers 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: None (Open label)

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58 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 D00264A (Triquilar)