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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

23 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-11-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Ritodrine (Pre-Par)

Group Type EXPERIMENTAL

Ritodrine

Intervention Type DRUG

Ritodrine (Pre-Par), maximum 400 µg/minute, IV

2

Atosiban (Tractocile)

Group Type EXPERIMENTAL

Atosiban

Intervention Type DRUG

Atosiban (Tractocile), maximum 300 µg/minute, IV

3

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Glucose 5%, IV

Interventions

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Ritodrine

Ritodrine (Pre-Par), maximum 400 µg/minute, IV

Intervention Type DRUG

Atosiban

Atosiban (Tractocile), maximum 300 µg/minute, IV

Intervention Type DRUG

Placebo

Glucose 5%, IV

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes