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Role of 5-Alpha Reductase in Mediating Testosterone Actions
NCT00070733Phase 3
Key facts
- Status
- Unknown
- Start
- Aug 2003
- Countries
- 1
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development
- Modality
- Small Molecules
- Conditions
- Hypogonadism
01
Overview
Phase 3, randomised, double-blind trial of testosterone enanthate in Hypogonadism (2 arms), sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development. Primary endpoints: Fat-free mass at 20 weeks, Muscle size at 20 weeks and 2 more. Status: unknown.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Testosterone + Placebo
Testosterone enanthate weekly + Placebo daily
Testosterone + Dutasteride
Testosterone enanthate weekly + Dutasteride daily
03
Who it enrols
Young healthy men with normal testosterone levels, excluding those with obesity, competitive sports participation, or conditions/medications affecting muscle/bone metabolism or androgen action.
04
Endpoints
Primary
Fat-free mass
Muscle size
Muscle strength
Leg power
Secondary
Sexual function
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