Interaction Between Fluvoxamine and Sildenafil

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2004-11-30

Brief Summary

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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

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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).

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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sildenafil, fluvoxamine

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Principal Investigators

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Walter E Haefeli, MD

Role: PRINCIPAL_INVESTIGATOR

Heidelberg University

Locations

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Dept. of Internal Medicine VI, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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K058

Identifier Type: -

Identifier Source: org_study_id