Interaction Between Fluvoxamine and Sildenafil - Tabular View

Tracking Information

First Received Date ^ICMJE

September 9, 2005

Last Updated Date

September 9, 2005

Start Date ^ICMJE

February 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Interaction Between Fluvoxamine and Sildenafil

Official Title ^ICMJE

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

Brief Summary

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

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).

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment

Condition ^ICMJE

Healthy

Intervention ^ICMJE

Drug: sildenafil, fluvoxamine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

November 2004

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT ID ^ICMJE

NCT00175981

Responsible Party

Study ID Numbers ^ICMJE

K058

Study Sponsor ^ICMJE

University of Heidelberg

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Walter E Haefeli, MD

University of Heidelberg

Information Provided By

University of Heidelberg

Verification Date

September 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP