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Interaction Between Fluvoxamine and Sildenafil

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00175981
First Posted: September 15, 2005
Last Update Posted: September 15, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Heidelberg University
  Purpose
Aim of the study is to assess the interaction between sildenafil and fluvoxamine and its effect on the venous response to sodium nitroprusside.

Condition Intervention Phase
Healthy Drug: sildenafil, fluvoxamine Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Pharmacokinetic and Pharmacodynamic Evaluation of the Interaction Between Fluvoxamine and Sildenafil in Healthy Males

Resource links provided by NLM:


Further study details as provided by Heidelberg University:

Primary Outcome Measures:
  • Drug-induced changes of hand vein compliance
  • Drug-induced changes of pharmacokinetic parameters

Estimated Enrollment: 12
Study Start Date: February 2003
Estimated Study Completion Date: November 2004
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00175981


Locations
Germany
Dept. of Internal Medicine VI, University of Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
Heidelberg University
Investigators
Principal Investigator: Walter E Haefeli, MD Heidelberg University
  More Information

ClinicalTrials.gov Identifier: NCT00175981     History of Changes
Other Study ID Numbers: K058
First Submitted: September 9, 2005
First Posted: September 15, 2005
Last Update Posted: September 15, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Sildenafil Citrate
Fluvoxamine
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Neurotransmitter Agents
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors