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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00679705

Enrollment

Registered

2008-05-19

Start date

2008-05-31

Completion date

2008-11-30

Last updated

2009-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Hemodynamics and arterial function of healthy females

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).

Interventions

DRUGRitodrine

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

DRUGAtosiban

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

DRUGPlacebo

Glucose 5%, IV

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.	240 minutes

Secondary

Measure	Time frame
Effect of the specific dosing levels of the medications on the level of arterial stiffness	240 minutes
Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure	240 minutes
Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall	240 minutes
Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance	240 minutes
Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure	240 minutes

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026