Interaction Between Fluvoxamine and Sildenafil - Full Text View

Sponsored by:	University of Heidelberg
Information provided by:	University of Heidelberg
ClinicalTrials.gov Identifier:	NCT00175981

Purpose

Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

Condition	Intervention	Phase
Healthy	Drug: sildenafil, fluvoxamine	Phase I

Drug Information available for: Sildenafil citrate Sildenafil Fluvoxamine maleate Fluvoxamine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment
Official Title:	Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males

Further study details as provided by University of Heidelberg:

Primary Outcome Measures:

Drug-induced changes of hand vein compliance
Drug-induced changes of pharmacokinetic parameters

Estimated Enrollment:	12
Study Start Date:	February 2003
Estimated Study Completion Date:	November 2004

Detailed Description:

In a randomised, double-blind, placebo-controlled, cross-over study in healthy men we will assess the effect of oral fluvoxamine (50mg qd on day 1-3; 100mg qd on day 4-10) on sildenafil kinetics (single oral 50mg dose on day 11). Sildenafil plasma concentrations will be determined by LC/MS. We will also assess the effect of sildenafil on venodilation induced by a constant dose-rate of the NO-donor sodium nitroprusside (SNP) during preconstriction with phenylephrine (dorsal hand vein compliance technique).

Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy, male individuals, age: 18-45.
Able and willing to give written informed consent

Exclusion Criteria:

Hypotension ( 65 mmHg diastolic and  100 mmHg systolic blood pressure)
Bleeding disorders in medical history
Intake of medication impairing platelet function or influencing coagulation (for example aspirin, NSAID and others) during the preceding 4 weeks
Known condition causing endothelial dysfunction (e.g. diabetes, hyperlipidaemia, arterial hypertension, hyperhomocysteinaemia, smoking)
Anatomic deformity of the penis like angulation, penile fibromatosis (peyronie’s disease) or diseases favouring priapism (e.g. leukaemia, plasmocytoma, sickle-cell anaemia)
Regular medication and/or treatment with drugs within the preceding 4-6 weeks (exclusion has to be decided in each case)
alcohol (>30 g/d) or drug abuse
Acute or chronic illness
Blood donation within the preceding 2 months
Participation in clinical trial within 2 month before the study
Drug and/or alcohol abuse.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175981

Locations

Germany, Baden-Württemberg
Dept. of Internal Medicine VI, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120

Sponsors and Collaborators

University of Heidelberg

Investigators

Principal Investigator:

Walter E Haefeli, MD

University of Heidelberg

More Information

Study ID Numbers:	K058
Study First Received:	September 9, 2005
Last Updated:	September 9, 2005
ClinicalTrials.gov Identifier:	NCT00175981
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Fluvoxamine
Sildenafil
Healthy
Serotonin

Additional relevant MeSH terms:

Vasodilator Agents
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Central Nervous System Depressants
Enzyme Inhibitors
Cardiovascular Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Phosphodiesterase Inhibitors
Serotonin Agents
Therapeutic Uses
Anti-Anxiety Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 16, 2009