Interaction Between Fluvoxamine and Sildenafil

Heidelberg University12 enrolled

Overview

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

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

sildenafil, fluvoxamineDRUG

Eligibility

Sex: MALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Dept. of Internal Medicine VI, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Drug-induced changes of hand vein compliance

Drug-induced changes of pharmacokinetic parameters

Data from ClinicalTrials.gov

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