What are the guidelines for using Sermorelin (growth hormone-releasing hormone (GHRH) analogue) in women?

Guidelines for Using Sermorelin in Women

There are currently no specific clinical guidelines for using Sermorelin (a growth hormone-releasing hormone analogue) in women, as it lacks FDA approval for use in adult women outside of diagnostic testing for growth hormone deficiency.

What is Sermorelin?

Sermorelin is a 29-amino acid analogue of human growth hormone-releasing hormone (GHRH) that stimulates the pituitary gland to produce and release growth hormone 1. It represents the shortest synthetic peptide with full biological activity of GHRH.

Current Approved Uses

• Sermorelin has been studied primarily for:
  • Diagnostic testing for growth hormone deficiency (1 μg/kg IV dose) 1
  • Treatment of idiopathic growth hormone deficiency in prepubertal children 1

Evidence for Use in Adult Women

The evidence for Sermorelin use specifically in adult women is extremely limited:

• A small study from 1997 examined the effects of nightly subcutaneous [Nle27]GHRH-(1-29)-NH2 (a Sermorelin analogue) at 10 μg/kg in age-advanced men and women for 16 weeks 2
  • In women, it increased nocturnal GH levels and skin thickness
  • Unlike men, women did not experience increases in lean body mass, insulin sensitivity, general well-being, or libido
  • Women showed increased GHBP (growth hormone binding protein) concentrations not seen in men
  • The study revealed potential gender differences in response to GHRH analogues 2

Safety Considerations for Women

Several important considerations should guide any off-label use of Sermorelin in women:

1. Pregnancy: Sermorelin crosses the placenta poorly, as demonstrated in a study where it was administered to pregnant women at term before cesarean section 3

2. Hormone-Sensitive Conditions: Women with hormone-sensitive conditions should exercise caution, as GHRH has been shown to influence:

   • Endometrial cell proliferation
   • Reproductive system function 4

3. Antiphospholipid Syndrome: While not specific to Sermorelin, women with antiphospholipid syndrome (APS) should be cautious with any hormone therapy 5

4. Osteoporosis Risk: Women with cancer-related bone loss or those receiving GnRH therapies causing ovarian suppression may require bone mineral density assessment and consideration of bone-modifying agents 6

5. Dosing Considerations: Sex-related differences in pharmacokinetics suggest women may require lower doses of certain medications compared to men 6

Practical Recommendations

If considering off-label use of Sermorelin in women (which lacks formal guideline support):

1. Screening: Evaluate for contraindications including active malignancy, intracranial lesions, and pregnancy

2. Dosing: Consider starting with lower doses than those used in men based on evidence of sex-related differences in drug metabolism 6

3. Monitoring: Regular assessment of:

   • IGF-1 levels
   • Glucose metabolism
   • Thyroid function
   • Side effects (most commonly reported: transient facial flushing and injection site pain) 1

4. Duration: Limited data on long-term effects necessitates careful follow-up and periodic reassessment of risk-benefit ratio

Conclusion

The use of Sermorelin in women remains largely investigational with insufficient evidence to support routine clinical use. The limited research suggests potential gender differences in response to GHRH analogues that warrant further investigation before specific guidelines can be established.