Interaction Between Fluvoxamine and Sildenafil

Heidelberg University

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: sildenafil, fluvoxamine

Study type

Interventional

Funder types

Other

Identifiers

NCT00175981

K058

Details and patient eligibility

About

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

Full 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).

Sex

Male

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.