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Effects of Miconazole on Blood Flow

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004575
First Posted: May 22, 2002
Last Update Posted: March 4, 2008
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:
National Institutes of Health Clinical Center (CC)
  Purpose

This study will investigate the effect of the drug miconazole on blood vessel dilation. Miconazole stops production of EDHF, a substance that causes arteries to dilate. EDHF is produced by the cells that line blood vessels.

Normal volunteers between the ages of 21 to 60 may participate in this study. Candidates will be screened for eligibility with a medical history, physical examination, electrocardiogram and routine laboratory tests. Those enrolled will be injected with miconazole to study its effects on blood vessels.

Study participants will take three aspirin tablets. After administration of a local anesthetic, small tubes will be inserted through a needle into the artery and vein of the forearm. These will be used to measure blood pressure and to draw blood samples during the study. Forearm blood flow will be measured using pressure cuffs placed on the wrist and upper arm, and a strain gauge (a rubber band device) placed around the forearm. When the cuffs are inflated, blood will flow into the arm, stretching the strain gauge, and the flow measurement will be recorded.

Small doses of four drugs-bradykinin, sodium nitroprusside, miconazole, and LNMMA-will be given through the arterial catheter. Bradykinin stimulates the release of EDHF and can lower blood pressure. Sodium nitroprusside causes blood vessels to dilate and is used to treat high blood pressure and heart failure. Miconazole is commonly prescribed to treat various infections, including vaginal yeast infections, jock itch and athlete's foot. In much higher doses, it is used to treat fungal infections that have spread to the lungs, brain, kidneys, or bladder. LNMMA inhibits production of nitric oxide, another substance produced by the lining cells of blood vessels.

Blood flow will be measured throughout the study, which will last approximately 3 hours.


Condition Intervention Phase
Healthy Drug: Miconazole, L-NMMA, Bradykinin Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Investigation of Miconazole as an Inhibitor of Endothelium-Derived Hyperpolarizing Factor

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 15
Study Start Date: February 2000
Estimated Study Completion Date: October 2001
Detailed Description:

The vascular endothelium synthesizes at least three potent vasodilator substances: nitric oxide (NO), prostacyclin and an endothelium-derived hyperpolarizing factor (EDHF). EDHF release is stimulated by receptor-dependent agonists such as acetylcholine and bradykinin (BK), and leads to hyperpolarization of the underlying smooth muscle cells presumably by opening Ca(2+)-activated K(+) channels. Indirect pharmacologic evidence suggests that EDHF is a cytochrome P450-derived arachidonic acid metabolite, presumably an epoxide.

Numerous inhibitors of EDHF have been defined in animal tissues. Of these, miconazole has proven to be safe when administered to humans as a topical and parenteral antifungal agent. At levels that are attained with routine clinical use, it has a rapid onset of action with high specificity of inhibition of EDHF in animal models. This study is designed to investigate the safety and efficacy of intra-arterial miconazole in inhibiting BK-mediated forearm vasodilation in normal volunteers.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Healthy male or female volunteers (age 21-60 years).

No presence of intercurrent illness.

No current smoking (within previous 5 years).

No hypertension (greater than 140/90).

No diabetes.

No hypercholesterolemia (total cholesterol greater than 240 mg/dl).

No pregnancy or menopause.

No renal failure (creatinine greater than 1.4 mg/dl).

No allergies to miconazole, parabens, castor oil or aspirin.

No bleeding disorders.

No consumption of any medications during the last one week, including vitamins and unconventional medications.

  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): NCT00004575


Locations
United States, Maryland
National Heart, Lung and Blood Institute (NHLBI)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00004575     History of Changes
Other Study ID Numbers: 000077
00-H-0077
First Submitted: February 17, 2000
First Posted: May 22, 2002
Last Update Posted: March 4, 2008
Last Verified: October 2001

Keywords provided by National Institutes of Health Clinical Center (CC):
Endothelium
Vasodilation
Vascular Biology
Venous Occlusion Plethysmography

Additional relevant MeSH terms:
Bradykinin
Miconazole
Vasodilator Agents
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP3A Inhibitors