Testosterone Treatment for Hypogonadal Men

Abbott

Status and phase: Completed; Phase 3

Conditions: Hypogonadism

Treatments: Drug: Placebo; Drug: Testosterone (T) Gel 1.62%

Study type: Interventional

Funder types: Industry

Identifiers

NCT00433199

S176.3.104

Details and patient eligibility

About

Demonstrate efficacy and safety of Testosterone Gel 1.62% for the treatment of hypogonadal men

Enrollment: 274 patients

Sex: Male

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low T males 18 - 80 years of age

Exclusion criteria

• Normal T levels
• Elevated Prostatic Specific Antigen (PSA)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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274 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

T-Gel 1.62%

Experimental group

Description:

Testosterone (T) gel 1.62%

Treatment:

Drug: Testosterone (T) Gel 1.62%