Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
Growth Hormone in Neuroendocrine Dysfunction With Severe Fibromyalgia Syndrome
The purpose of this study is to evaluate the efficacy of recombinant human growth hormone
 (r-hGH) treatment in severe fibromyalgia subjects with growth axis dysfunction.
Inclusion Criteria:

 -  Women aged greater than or equal (>=) 18 years

 -  Fibromyalgia diagnosed at least one year before

 -  History of generalized pain and at least 16 positive tender points (1990 American
 College of Rheumatology [ACR] criteria)

 -  Body Mass Index (BMI) less than or equal to(=<) 32

 -  Normal GH stimulation test (insulin)

 -  Stable (>= 3 months unchanged) standard treatment with amitriptyline (10-50 milligram
 per day [mg/day]) plus selective serotonin reuptake inhibitor (10-40 mg/day) plus
 tramadol (25-400 mg/day)

 -  Active rehabilitation program during the previous year (at least 30 minutes/day)

 -  Fibromyalgia Impact Questionnaire (FIQ) score >=75

 -  IGF-1 serum level =< 150 nanogram/milliliter (ng/mL) otherwise =< 2 SD of the local
 lab normality)

 -  Normal response to IGF-1 generation test

 -  Chronic Fatigue Symptoms (Multidimensional Assessment of Fatigue [MAF])

 -  Effective anti-conception

 -  Willingness to comply with the protocol

 -  Written Informed consent

 Exclusion Criteria:

 -  Major psychiatric condition

 -  Rheumatic disease, including systemic lupus erythematosus (SLE)

 -  Previous or current malignancies, active or inactive

 -  Clinical history intracranial space occupying lesion

 -  Reactive or secondary (rheumatoid arthritis [RA], osteoarthritis) fibromyalgia
 syndrome (FMS)

 -  Antinuclear antibody (ANA) greater than or equal 1:80

 -  Abnormal Creatine phosphokinase (CPK) or aldolase serum levels

 -  Not controlled thyroid disease in the last 3 months (free Thyroxine [T4] and
 Thyrotrophin-stimulating hormone [TSH] serum levels)

 -  Diabetes mellitus

 -  Adrenal gland disease (any abnormal cortisolemia, will be confirmed by 24-hour
 cortisoluria)

 -  Pregnancy or breast feeding

 -  Known to be hypersensitive to somatotropin or any of the excipients