Status:
COMPLETED
Influence of Tocolytical Medications on Hemodynamics (Central and Peripheral) and Vascular Function in a Pilot Study to Determine the Design of the Final Study and the Final Study Itself
Lead Sponsor:
University Hospital, Ghent
Conditions:
Healthy
Eligibility:
FEMALE
20-40 years
Phase:
PHASE1
Brief Summary
This trial will consist of two parts: A pilot study in a three-way cross over trial to determine the highest well tolerated dose of Ritodrine (Pre-Par®), the impact of Atosiban (Tractocile®) on the h...
Eligibility Criteria
Inclusion
- Age between 20 and 40 years old;
- In good health, especially no cardiovascular diseases, obstructive lung diseases, chronic kidney diseases or diabetes mellitus.
- Using a proper anticonception method (orally, subcutaneously);
- A negative pregnancy test.
Exclusion
- Intolerance of Ritodrine;
- On chronic medication, except oral and subcutaneous contraception
- History or present presentation of cardiac arrythmias;
- Risk of being pregnant or less than 6 months postpartum;
- Giving breastfeeding;
- Previous uteral surgery;
- Using an intra-uteral device (IUD);
- A severe addiction: nicotine (\> 10 cigarettes/day), alcohol (\> 3 units/day), caffeine (\> 5 units/day) or any extralegally drugs.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00679705
Start Date
May 1 2008
End Date
November 1 2008
Last Update
April 20 2009
Active Locations (1)
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1
University Hospital Ghent
Ghent, Belgium, 9000