Interaction Between Fluvoxamine and Sildenafil

Condition(s) targeted: Healthy

Intervention: sildenafil, fluvoxamine (Drug)

Phase: Phase 1

Status: Completed

Sponsored by: University of Heidelberg

Official(s) and/or principal investigator(s):
Walter E Haefeli, MD, Principal Investigator, Affiliation: University of Heidelberg

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

Official title: Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males

Study design: Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Primary outcome:

Drug-induced changes of hand vein compliance

Drug-induced changes of pharmacokinetic parameters

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).

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

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.

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

Starting date: February 2003
Ending date: November 2004
Last updated: September 9, 2005