check_circleStudy Completed

Contraception

Bayer Identifier:

90927

ClinicalTrials.gov Identifier:

NCT00185224

EudraCT Number:

Not Available

EU CT Number:

Not Available
Metabolism study to investigate the impact of a sequential oral contraceptive

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.

Key Participants Requirements

Sex

Female

Age

18 - 50 Years
  • - Healthy female volunteers between 18 and 50 years requiring contraception
  • - 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
March 2005 - March 2006
Phase
Phase 2
Could I Receive a placebo
No
Products
Natazia/Qlaira (EV/DNG, BAY86-5027)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
Bayer Schering Pharma AG - Clin. Pharm. BerlinBerlin, 13342, Germany

Primary Outcome

  • Impact on metabolic parameters (e.g. hemostatic parameters) after 6 month treatment
    date_rangeTime Frame:
    Baseline, Cycle 7
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    Safety Issue:
    None

Secondary Outcome

  • Measurement of PK parameters
    date_rangeTime Frame:
    Cycle 4, Cycle 7
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    Safety Issue:
    None

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

Additional Information

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