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

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: Female

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 hemodynamics and hence the design of the final study.

The final study is planned as a three-way crossover trial to investigate and compare the cardiovascular effects of Ritodrine, Atosiban and placebo to relate those effects to the pharmacokinetics of Ritodrine and Atosiban (PK/PD modelling).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Ghent
• Treatments: Atosiban; Ritodrine; Vasotocin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.