Phase II Study of Leuprolide and Testosterone for Men With Kennedy's Disease or Other Motor Neuron Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004771

Enrollment

Registered

2000-02-25

Start date

1992-10-31

Completion date

Unknown

Last updated

2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis, Spinal Muscular Atrophy, Spinobulbar Muscular Atrophy

Keywords

amyotrophic lateral sclerosis, motor neuron disease, neurologic and psychiatric disorders, rare disease, spinal and bulbar muscular atrophy, spinal muscular atrophy, Kennedy's Syndrome

Brief summary

OBJECTIVES: I. Evaluate the effects of androgen suppression with leuprolide and androgen replacement with testosterone enanthate on muscle strength in men with Kennedy's disease or other motor neuron disease.

Detailed description

PROTOCOL OUTLINE: All patients receive androgen suppression with leuprolide acetate injections every 4 weeks for 6 months, plus hormone replacement therapy with testosterone enanthate injections every week for 24 weeks.

Interventions

DRUGleuprolide

DRUGtestosterone

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Men aged 18 and over with motor neuron disease, i.e.: * X-linked spinal and bulbar muscular atrophy (Kennedy's disease) * Confirmed by androgen receptor, exon-1 mutation genotype * Amyotrophic lateral sclerosis * Spinal muscular atrophy Significant muscle weakness on manual muscle testing No prisoners No mental disability

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026