NCT00679705CompletedPhase 1
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.
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- University Hospital, Ghent
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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.
Arms & Interventions
1
Experimental
Ritodrine (Pre-Par)
Intervention: Ritodrine (Drug)
2
Experimental
Atosiban (Tractocile)
Intervention: Atosiban (Drug)
3
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Hemodynamical effects of Ritodrine and Atosiban in comparison of those of placebo.
Time Frame: 240 minutes
Secondary Outcomes
- 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)
Investigators
Study Sites (1)
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