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Analogous Analogs: Considerations Regarding Off-Label Use of Gonadotropin-Releasing Hormone Analogs Among Transgender Adolescents

  • 0At the time of the research, the author was unaffiliated.
American Journal of Public Health +

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July 17, 2025

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July 17, 2025

View abstract on PubMed

Summary

This summary is machine-generated.

Gonadotropin-releasing hormone (GnRH) analogs are standard care for gender dysphoria but are often off-label. This analysis explores policy pathways to support FDA approval for this use in adolescents.

Area Of Science

  • Public Health Policy
  • Endocrinology
  • Adolescent Medicine

Background

  • Gonadotropin-releasing hormone (GnRH) analogs are a long-standing, effective treatment for adolescent gender dysphoria.
  • Despite decades of use, GnRH analogs are frequently prescribed off-label for gender dysphoria, mirroring their use in cisgender adolescents.
  • The off-label status is controversially used to justify legislative restrictions on gender-affirming care.

Purpose Of The Study

  • To critically examine the politicization of GnRH analog use in adolescents with gender dysphoria.
  • To explore how public health policies can facilitate the approval of supplemental indications for GnRH analogs for gender dysphoria.

Main Methods

  • Policy analysis of existing regulatory frameworks and historical precedents.
  • Examination of arguments surrounding off-label drug use and pediatric gender-affirming care.
  • Consideration of prospective public health strategies.

Main Results

  • The 'off-label' argument is a politicized tactic to restrict access to evidence-based care.
  • Existing policies can be leveraged to support formal approval for GnRH analog use in gender dysphoria.
  • Historical public health approaches offer models for expanding drug indications.

Conclusions

  • Challenging the politicization of off-label use is crucial for advancing equitable access to care.
  • Proactive public health policy can lead to formal FDA approval of GnRH analogs for adolescent gender dysphoria.
  • Securing supplemental indications will protect and legitimize this vital medical treatment.

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