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Metabolism Study to Investigate the Impact of a Sequential Oral Contraceptive

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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)

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)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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