Clinical trial NCT00679705: 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
Official title: Pilot Study: A Dose-Response Finding Study of Ritodrine (Pre-Par®) to Find the Highest Well Tolerated Dose in Young, Healthy, Female Volunteers. To Find the Size-Order of the Hemodynamical Effects of Ritodrine (PrePar®) and Atosiban (Tractocile®) to Determine the Relevance of a PK/PD-Modelling in the Final Study. Final Study: Investigating the Influence of Tocolytical Medications: Ritodrine (PrePar®) and Atosiban (Tractocile®) at the Clinical Dose on the Hemodynamics and Arterial Function in Healthy Female Volunteers, Compared to Placebo During Continuous Intravenous Infusion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Hemodynamics and arterial function of healthy females
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
First posted: 2008-05-19
Enrollment: 23
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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).


Eligibility 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.

Primary outcomes:
measure: Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.
timeFrame: 240 minutes
Secondary outcomes:
measure: Effect of the specific dosing levels of the medications on the level of arterial stiffness
timeFrame: 240 minutes
measure: Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure
timeFrame: 240 minutes
measure: Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall
timeFrame: 240 minutes
measure: Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance
timeFrame: 240 minutes
measure: Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure
timeFrame: 240 minutes
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
Study officials:
affiliation: University Hospital, Ghent
name: Luc Van Bortel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: