Trial Condition(s):
Contraception
Metabolism study to investigate the impact of a sequential oral contraceptive
Bayer Identifier:
90927
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Bayer Schering Pharma AG - Clin. Pharm. Berlin Berlin, Germany, 13342 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A single-center, open-label, controlled, randomized study to investigate the impact of a sequential oral contraceptive (SH T00658ID) as compared to a sequential oral contraceptive containing ethinylestradiol and levonorgestrel (SH D00264A) on plasma lipids, hemostatic variables, and carbohydrate metabolism in healthy female volunteers aged 18-50 years over 7 treatment cycles, including the pharmacokinetics
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Prevention
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
2
Primary Outcome
- Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatmentTimeframe: Baseline, Cycle 7
Secondary Outcome
- Measurement of PK parametersTimeframe: Cycle 4, Cycle 7
Additional Information
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