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Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy

This study has been completed.
Information provided by:
Ramathibodi Hospital Identifier:
First received: February 25, 2009
Last updated: May 20, 2015
Last verified: February 2009

This is a therapeutic trial study to demonstrate whether Goserelin, a LHRH agonist has benefit in SBMA


  1. To study effects of Goserelin to clinical course of patients with spinal and bulbar muscular atrophy in Thailand
  2. To demonstrate physiological and pathological changes in treated patients with Goserelin.
  3. To assess tolerability and adverse effect of Goserelin therapy

Condition Intervention Phase
Spinobulbar Muscular Atrophy
Kennedy's Disease
Drug: Goserelin
Procedure: Electrophysiologic study
Procedure: tissue biopsy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Goserelin (Zoladex®) in Spinal and Bulbar Muscular Atrophy in Thai Patients

Resource links provided by NLM:

Further study details as provided by Ramathibodi Hospital:

Primary Outcome Measures:
  • muscle power [ Time Frame: every 3 months ]

Secondary Outcome Measures:
  • electrophysiologic study (Nerve conduction and Electromyogram) [ Time Frame: every 3 months ]

Enrollment: 10
Study Start Date: April 2008
Study Completion Date: November 2013
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Goserelin
    Goserelin 10.8 mg SC every 3 months
    Other Name: Zoladex LA
    Procedure: Electrophysiologic study
    Nerve conduction study Electromyogram
    Other Names:
    • NCV
    • EMG
    Procedure: tissue biopsy
    skin and muscle biopsy before and after treatment every year

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Provision of informed consent
  2. Males, age over 20 years, undesired fertility
  3. Have positive family history of muscle weakness with these clinical signs:

    • bulbar involvement (difficulty in breathing, swallowing, talking)
    • muscle atrophy with or without fasciculation
    • decrease or normal deep tendon reflex
    • normal Babinski response
    • no sensory impairment
    • mild tremor (either postural or intention)
    • gynecomastia
    • decrease libido and infertility
  4. Subjects have a confirmed diagnosis to SBMA by both NCV test and DNA study demonstrated the number of CAG repeated more than 35.

Exclusion Criteria:

  1. Have weakness caused by other etiologies and have liver or kidney disease.
  2. Have currently prostatic cancer
  3. Want to have a child
  4. Participation in a clinical study during the last 30 days.
  5. Females and children age < 20 years old
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Please refer to this study by its identifier: NCT00851461

Medical Genetics and Molecular Medicine Unit,, Department of Medicine, Ramathibodi Hospital
Bangkok, Thailand, 10400
Sponsors and Collaborators
Ramathibodi Hospital
Principal Investigator: Thanyachau Sura, M.D., MRCP Ramathibodi Hospital
  More Information

Responsible Party: Dean of Ramathibodi Hospital, Faculty of Medicine, Ramathibodi Hospital, Bangkok, Thailand Identifier: NCT00851461     History of Changes
Other Study ID Numbers: ID11-50-17
Study First Received: February 25, 2009
Last Updated: May 20, 2015

Keywords provided by Ramathibodi Hospital:
Spinobulbar muscular atrophy
Kennedy's disease
Electrophysiologic study
Inclusion body

Additional relevant MeSH terms:
Muscular Atrophy
Bulbo-Spinal Atrophy, X-Linked
Muscular Disorders, Atrophic
Pathological Conditions, Anatomical
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Atrophy, Spinal
Spinal Cord Diseases
Central Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Motor Neuron Disease
Neuromuscular Diseases
Genetic Diseases, X-Linked
Genetic Diseases, Inborn
Muscular Diseases
Musculoskeletal Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on April 28, 2017