Interaction Between Fluvoxamine and Sildenafil

This study has been completed.
Sponsor:
Information provided by:
Heidelberg University
ClinicalTrials.gov Identifier:
NCT00175981
First received: September 9, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 9, 2005
September 9, 2005
February 2003
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  • Drug-induced changes of hand vein compliance
  • Drug-induced changes of pharmacokinetic parameters
Same as current
No Changes Posted
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Interaction Between Fluvoxamine and Sildenafil
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.

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).

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Healthy
Drug: sildenafil, fluvoxamine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
12
November 2004
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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.
Male
18 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00175981
K058
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Heidelberg University
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Principal Investigator: Walter E Haefeli, MD Heidelberg University
Heidelberg University
September 2005

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