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Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate in Healthy Volunteers (INFLUX-VS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00710099
First Posted: July 4, 2008
Last Update Posted: October 6, 2011
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 (Responsible Party):
University Hospital, Grenoble
  Purpose
Iontophoresis is a employed to facilitate drug absorption without systemic effect. This study investigates cutaneous microcirculation when we associate sildenafil per os with SNP via iontophoresis.

Condition Intervention
Healthy Drug: sildenafil Drug: nitroprussiate iontophoresis

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Oral Sildenafil With Digital Therapeutic Iontophoresis of Sodium Nitroprussiate on Cutaneous Blood Flow in Healthy Volunteers

Resource links provided by NLM:


Further study details as provided by University Hospital, Grenoble:

Primary Outcome Measures:
  • variation of conductance of nitroprussiate iontophoresis associated with oral sildenafil [ Time Frame: one hour ]

Secondary Outcome Measures:
  • To assess the effect of oral sildenafil (50 mg and 100 mg) on skin microvascular reactivity to local cooling, on the forearm and the finger [ Time Frame: one hour ]

Estimated Enrollment: 40
Study Start Date: July 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: sildenafil
systemic absorption of sildenafil
Active Comparator: 2
SNP iontophoresis
Drug: nitroprussiate iontophoresis
nitroprussiate iontophoresis

Detailed Description:
The main outcome is the proof of concept of effect of systemic absorption sildenafil on cutaneous microcirculation associated with SNP iontophoresis.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age over 18
  • No significant medical history

Exclusion Criteria:

  • Age under 18
  • Period of exclusion for an other study
  • Pregnancy
  • Breast feeding
  • Severe disease
  • Cigarette smoking
  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): NCT00710099


Locations
France
Clinical Researsh Centre
Grenoble, Isere, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: Jean-Luc CRACOWSKI, MD Institut National de la Santé Et de la Recherche Médicale, France
  More Information

Publications:
Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00710099     History of Changes
Other Study ID Numbers: DCIC/08/08
First Submitted: July 2, 2008
First Posted: July 4, 2008
Last Update Posted: October 6, 2011
Last Verified: October 2011

Keywords provided by University Hospital, Grenoble:
iontophoresis
cutaneous microcirculation
sildenafil
Healthy volunteers

Additional relevant MeSH terms:
Sildenafil Citrate
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents