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NCT Number: 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

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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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ritodrine

Drug

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

Atosiban

Drug

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

Placebo

Drug

Glucose 5%, IV

Primary outcomes

  1. Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.

    Time frame: 240 minutes

Secondary outcomes

  1. Effect of the specific dosing levels of the medications on the level of arterial stiffness

    Time frame: 240 minutes

  2. Effect of the specific dosing levels of the medications on the effects of the peripheral pulse wave reflections on the central, systolic blood pressure

    Time frame: 240 minutes

  3. Effect of the specific dosing levels of the medications on the distensibility of the blood vessel wall

    Time frame: 240 minutes

  4. Effect of the specific dosing levels of the medications on the cardiac output and total peripheral resistance

    Time frame: 240 minutes

  5. Effect of the specific dosing levels of the medications on peripheral brachial, systolic and diastolic blood pressure

    Time frame: 240 minutes

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 19, 2008
Registry last updated
Apr 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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