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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00042536 |
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Date of registration:
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31/07/2002 |
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Primary sponsor: |
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Public title:
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Effects of Yohimbine and Naltrexone on Sexual Function
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Scientific title:
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Effects of Alpha-2 Adrenergic and Opiate Receptor Blockade on Sexual Function in Healthy Male Volunteers |
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Date of first enrolment:
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July 2002 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00042536 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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INCLUSION CRITERIA
Subjects must be medically healthy and free of mental illness, take no medication, and
must report no problems with their sexual function. They are required to be sexually
active, including successful penetrative sexual intercourse acts.
For assessments of sexual function before and after the study subjects are required to
complete a detailed daily diary recording their erectile activity for 7 days before the
first study session, and for 7 days after completion of the study.
EXCLUSION CRITERIA
Persons having taken antidepressant or other medications likely to alter monoamine
neurochemistry or cerebrovascular and cardiovascular function within 6 months prior to the
study will be excluded.
Individuals will also be excluded if they have: a) evidence for an axis I psychiatric
disorder (DSM-IV criteria), b) medical or neurological illnesses likely to affect
physiology or anatomy, c) a history of drug (including BZDs) or alcohol abuse within 1
year or a lifetime history of alcohol or drug dependence (DSM IV criteria), d) smokers, e)
diagnosis of a sexual disorder, f) criminal history.
Persons must exhibit no or only moderate alcohol use. Persons with current or previous
regular use ( more than 4 weeks) of BZDs and excessive use of alcohol (more than 8
ounces/day) in the past or presence are ineligible to participate, as such drug use
confound the results.
Individuals beyond age 50 are excluded because subjects beyond age 50 have a far greater
likelihood of showing subtile, albeit clinical irrelevant disturbances in erectile
function.
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Erectile Dysfunction
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Intervention(s)
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Drug: Naltrexone HCL/ Yohimbine HCL
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Secondary ID(s)
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02-M-0262
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020262
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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