What is the appropriate use and dosage of Sermorelin (growth hormone-releasing hormone (GHRH) analogue) for adult women with growth hormone deficiency or hormonal imbalance?

Sermorelin Use in Women: Not Recommended for Routine Clinical Practice

Sermorelin is not approved or recommended for use in adult women with growth hormone deficiency or hormonal imbalance, and there is no established evidence supporting its efficacy or safety in this population. The available evidence is limited to pediatric growth hormone deficiency diagnosis and treatment, with no guideline support for adult female use 1.

Evidence Limitations and Clinical Context

Approved Indications

• Sermorelin (a 29 amino acid GHRH analogue) is only studied and validated for diagnostic testing of growth hormone deficiency in children using intravenous administration at 1 mcg/kg bodyweight 1
• Limited pediatric data suggest subcutaneous sermorelin 30 mcg/kg bodyweight at bedtime may promote growth in prepubertal children with idiopathic growth hormone deficiency, but long-term effects on final adult height remain undetermined 1
• No clinical trials, guidelines, or FDA approval exist for sermorelin use in adult women 1

Why Sermorelin Is Not Appropriate for Adult Women

Growth hormone therapy in adults carries significant metabolic risks that outweigh potential benefits in most clinical scenarios:

• GH administration worsens insulin resistance rather than improving it, with all studies showing rises in serum insulin levels (fasting and post-glucose load) 2
• GH treatment increases fasting blood glucose, with some studies reporting new cases of impaired glucose tolerance or frank diabetes mellitus 2
• Even minor reductions in insulin sensitivity from GH therapy may increase cardiovascular risk, contradicting the theoretical benefit of treating GH deficiency 2

Appropriate Management of Adult Growth Hormone Deficiency

Diagnostic Confirmation Required

If adult-onset GH deficiency is suspected in a woman, diagnosis must be confirmed with:

• Insulin-induced hypoglycemia test or glucagon stimulation test to assess GH reserve, using age- and sex-specific control data 3, 4
• Measurement of IGF-I levels with age- and sex-specific reference ranges, as GH secretion and IGF-I decline with normal aging 3
• Differentiation between childhood-onset GHD (developmental disorder with adapted metabolic balance) versus adult-onset GHD (metabolic disorder with hormonal imbalance affecting health status) 3

Treatment Considerations for Confirmed Adult GH Deficiency

If recombinant human GH therapy is indicated after confirmed diagnosis:

• Use recombinant human GH (somatropin), not sermorelin, as it is the only evidence-based treatment for adult GH deficiency 4
• Dose at 12.5 mcg/kg/day subcutaneously, which is substantially lower than pediatric dosing 3
• Older patients require even lower doses to minimize side effects, particularly fluid retention and joint symptoms 3
• Monitor for adverse metabolic effects including worsening insulin resistance, elevated glucose, and cardiovascular risk 2

Critical Safety Monitoring

• Assess for development of impaired glucose tolerance or diabetes mellitus during GH therapy, as this occurs in a subset of treated patients 2
• Measure glycosylated hemoglobin (HbA1c), fasting glucose, and post-glucose load insulin levels regularly 2
• Evaluate cardiovascular risk factors, as the theoretical benefit of reducing excess cardiovascular mortality in hypopituitarism (mortality ratios 1.7-2.2) may be offset by GH-induced insulin resistance 2

Common Clinical Pitfalls

Do not use sermorelin as a substitute for recombinant human GH in adults—the evidence base is entirely pediatric, and subcutaneous sermorelin 30 mcg/kg bodyweight produces inferior height velocity increases compared to somatropin even in children 1

Do not assume GH deficiency causes insulin resistance in hypopituitarism—there is no direct evidence that cardiovascular risk in hypopituitarism results from GH deficiency specifically, and GH therapy may paradoxically worsen insulin sensitivity 2

Do not prescribe GH therapy without confirmed biochemical GH deficiency—normal GH responses to provocative testing can occur in hypothalamic deficits, requiring subnormal responses to multiple tests for diagnosis 1

Alternative Hormonal Management for Women

If the clinical concern is hormonal imbalance in women rather than confirmed GH deficiency, appropriate evidence-based options include:

• Hormone replacement therapy for premature ovarian insufficiency or menopause using transdermal 17β-estradiol 50-100 mcg daily with micronized progesterone 200 mg daily for 12-14 days per month 5
• Treatment should continue until the average age of natural menopause (45-55 years) in women with premature ovarian insufficiency 5
• Annual clinical review focusing on compliance, symptom control, and risk-benefit reassessment is recommended 5