Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
NCT ID: NCT01786473
Last Updated: 2013-02-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
240 participants
INTERVENTIONAL
2012-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Testogel 1% 5g QD
Testogel 1%
Placebo gel 5g QD
Placebo
Interventions
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Testogel 1%
Placebo
Eligibility Criteria
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Inclusion Criteria
* A morning (8:00-10:00) serum Total Testosterone concentration of ≤ 300 ng/dL, confirmed by a second measurement of morning serum Total Testosterone concentration ≤ 300 ng/dL (samples to be taken 1 - 3 weeks apart)
Exclusion Criteria
* Hematocrit \> 50%
* Major psychiatric illness
* Unable to understand the protocol or to give informed consent
* Use of paroxetine and clomipramine
* Active alcoholism
* History of drug abuse within the past five years;
* Use of drugs that might interfere with the results of the study (e.g., antiandrogen, estrogens or P 450 enzyme inducers, barbiturates);
* BMI \< 18 or \> 30 according to Chinese BMI references;
* Generalized skin disease that may affect absorption of T (e.g., psoriasis) or a known skin intolerance to alcohol;
* Prolactin \> 40 mcg/L;
* Untreated severe obstructive sleep apnea;.
* Uncontrolled or poorly controlled heart failure
18 Years
68 Years
MALE
No
Sponsors
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Laboratoires Besins International
INDUSTRY
Responsible Party
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Principal Investigators
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Jie Jin
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Locations
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Peking University First Hospital
Beijing, , China
Countries
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Central Contacts
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Other Identifiers
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01BHR11
Identifier Type: -
Identifier Source: org_study_id
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