Trial Condition(s):

Contraception

Metabolism study to investigate the impact of a sequential oral contraceptive

Bayer Identifier:

90927

ClinicalTrials.gov Identifier:

NCT00185224

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
58
Trial Dates
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Phase
2
Could I receive a placebo?
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Bayer Schering Pharma AG - Clin. Pharm. Berlin

Berlin, Germany, 13342

Status
Completed
 

Trial Design