check_circleStudy Completed

pregnancy, unplanned

Bayer Identifier:

91477

ClinicalTrials.gov Identifier:

NCT00318799

EudraCT Number:

2005-004688-45

EU CT Number:

Not Available
Impact of SH T00658ID as compared to a monophasic contraceptive containing ethinylestradiol and levonorgestrel (SH D01155E) on hemostatic parameters

Trial purpose

The aim of this study is to evaluate the impact of SH T00658ID (EV/DNG tablet) on hemostatic parameters in comparison to a reference oral contraceptive (OC) (SH D01155E) in a crossover design.

Key Participants Requirements

Sex

Female

Age

18 Years

  • - Healthy female volunteers

  • - Pregnancy or lactation
    - Any condition that might interfere with the outcome as all contraindications for OC use.

Trial summary

Enrollment Goal
29
Trial Dates
April 2006 - May 2007
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
Dinox B.V.Groningen, 9713GZ, Netherlands

Primary Outcome

  • Intraindividual absolute changes from Baseline in the Parameters of thrombin and fibrin turnover
    date_rangeTime Frame:
    Baseline, Cycle 3 of each treatment period
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    Safety Issue:
    No

Secondary Outcome

  • Intraindividual absolute changes from Baseline in Pro- and anti-coagulatory parameters and the parameter of thrombin and fibrin turnover (activation marker): Prothrombin (Factor II).
    date_rangeTime Frame:
    Baseline, Cycle 3 of each treatment period
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    Safety Issue:
    No
  • Adverse events
    date_rangeTime Frame:
    2 treatment periods (3 cycles each), 2 cycles whash out-period and 14 days follow-up period
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    Safety Issue:
    Yes

Trial design

A single-centre, open-label, crossover, controlled, randomized study to investigate the impact of SH T00658ID as compared to a monophasic contraceptive containing ethinylestradiol and levonorgestrel (SH D01155E) on hemostatic parameters in 30 healthy female volunteers over 3 treatment cycles
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
2

Additional Information

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