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NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers

NCT00647868 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-03-30

No results posted yet for this study

Summary

In this study the serum concentration of testosterone and its main metabolite DHT will be measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment regimens (once and twice daily) and administration times will be tested. The serum levels obtained will be compared with those of healthy men.

It is expected that intranasal administration of Nasobol will restore testosterone and DHT levels to nearly normal.

Conditions

  • Hypogonadism

Interventions

DRUG

testosterone

Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application

Sponsors & Collaborators

  • Acerus Pharmaceuticals Corporation

    lead INDUSTRY

Principal Investigators

  • Christina Wang, MD · General Clinical Research Center - Harbor UCLA Medical center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-05-31
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00647868 on ClinicalTrials.gov