Interaction Between Fluvoxamine and Sildenafil

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00175981

Enrollment

Registered

2005-09-15

Start date

2003-02-28

Completion date

2004-11-30

Last updated

2005-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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).

Interventions

DRUGsildenafil, fluvoxamine

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to 45 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
Drug-induced changes of hand vein compliance	—
Drug-induced changes of pharmacokinetic parameters	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026