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

Ghent University Hospital (UZ)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: Atosiban; Drug: Ritodrine

Study type: Interventional

Funder types: Other

Identifiers

NCT00679705

2008/110

Details and patient eligibility

About

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).

Enrollment: 23 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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23 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

Ritodrine (Pre-Par)

Treatment:

Drug: Ritodrine

2

Experimental group

Description:

Atosiban (Tractocile)

Treatment:

Drug: Atosiban

3

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo