Official Title: “Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males”

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

Study Type: Interventional

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

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).

Intervention(s) in this Clinical Trial

• Drug: sildenafil, fluvoxamine

Primary Measures

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

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.

Gender Eligibility for this Clinical Trial: Male

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Heidelberg

Overall Clinical Trial Officials and Contacts

Walter E Haefeli, MD Principal Investigator University of Heidelberg  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00175981

Study ID Number: K058

ClinicalTrials.gov Identifier: NCT00175981

Health Authority: Germany: Federal Institute for Drugs and Medical Devices