Testogel® (Testosterone Gel 50mg/5g) in the Treatment of Male Hypogonadism
NCT01786473 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 240
Last updated 2013-02-08
Summary
The purpose of this study is to evaluate the safety and efficacy of Testogel® 50mg/5g gel administered once daily (QD, morning dosing) compared to placebo administered once daily (QD, morning dosing), for 3 months, in hypogonadal men with testosterone deficiency being confirmed by clinical features and biochemical tests. For men with hypogonadism, treatment aims to restore testosterone levels to normal physiological range.
Conditions
- Hypogonadism
Interventions
- DRUG
-
Testogel 1%
- DRUG
Sponsors & Collaborators
-
Laboratoires Besins International
lead INDUSTRY
Principal Investigators
-
Jie Jin · Peking University First Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 68 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-12-31
- Primary Completion
- 2014-12-31
Countries
- China
Study Locations
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