NCT00175981

CompletedPhase 1

Interaction Between Fluvoxamine and Sildenafil

Heidelberg University Source

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Other study identifiers

Sponsor study identifier

K058

Study Type

interventional

Reported enrollment (type unavailable)

12

Locations

1 country

Sites

1

Timeline

Study Start

February 2003

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

Not reported

Date not reported

Study Completion

November 2004

Date type not reported

This date has not been verified as actual or estimated.

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Reported enrollment (type unavailable): 12 participants
Study completion date: November 2004
Date type not reported
This date has not been verified as actual or estimated.
Listed locations: 1 countries · 1 sites

Trial Relationships

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Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

Study Start
February 2003
Date type not reported
This date has not been verified as actual or estimated.
Study Completion
November 2004
Date type not reported
This date has not been verified as actual or estimated.
First Submitted
September 9, 2005
Actual (reported)
First Posted
September 15, 2005
Actual (reported)

Last Updated: September 15, 2005
Status Verified: September 2005
Last Update Submitted: September 9, 2005

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

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

Interventions

sildenafil, fluvoxamineDrug

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
sildenafil, fluvoxamine
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 45 Years

Sexmale

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Healthy, male individuals, age: 18-45.
Able and willing to give written informed consent

You may not qualify if:

Sponsors & Collaborators

Heidelberg University
Otherlead

Study Sites (1)

Dept. of Internal Medicine VI, University of Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

MeSH Terms

Interventions

Sildenafil CitrateFluvoxamine

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingOximesHydroxylamines

Study Officials

Walter E Haefeli, MD
Heidelberg University
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 1
Allocation: RANDOMIZED
Masking: DOUBLE
Purpose: PREVENTION
Intervention Model: CROSSOVER
Sponsor Type: OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 15, 2005

Study Start

February 2003

Date type not reported

This date has not been verified as actual or estimated.

Study Completion

November 2004

Date type not reported

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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)
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.

Contact the study team to confirm eligibility.

Amines

This date has not been verified as actual or estimated.

Last Updated

September 15, 2005

Record last verified: 2005-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT00175981
Data provider: ClinicalTrials.gov
Source updated: 2005-09-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:30:15 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

Study Completion

First Submitted

First Posted

Conditions

Outcome Measures

Primary Outcomes (2)

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Source record

Locations