Toward a Lowest Effective Dose of Cyproterone Acetate in Trans Women: Results From the ENIGI Study.

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  • Additional Information
    • Source:
      Publisher: Oxford University Press Country of Publication: United States NLM ID: 0375362 Publication Model: Print Cited Medium: Internet ISSN: 1945-7197 (Electronic) Linking ISSN: 0021972X NLM ISO Abbreviation: J Clin Endocrinol Metab Subsets: MEDLINE
    • Publication Information:
      Publication: 2017- : New York : Oxford University Press
      Original Publication: Springfield, Ill. : Charles C. Thomas
    • Subject Terms:
      Cyproterone Acetate/*administration & dosage ; Gender Dysphoria/*drug therapy ; Transsexualism/*drug therapy; Androgen Antagonists/administration & dosage ; Androgen Antagonists/adverse effects ; Belgium ; Cohort Studies ; Cyproterone Acetate/adverse effects ; Dose-Response Relationship, Drug ; Female ; Gender Identity ; Hormone Replacement Therapy/adverse effects ; Hormone Replacement Therapy/methods ; Humans ; Italy ; Longitudinal Studies ; Male ; Netherlands ; Sex Reassignment Procedures/adverse effects ; Sex Reassignment Procedures/methods ; Treatment Outcome
    • Abstract:
      Context: Cyproterone acetate (CPA) is a competitive inhibitor of the androgen receptor and exerts negative hypothalamic feedback. It is often used in combination with estrogens in trans women to achieve feminization. However, CPA has been associated with side effects such as changes in liver enzyme concentrations and increases in prolactin concentrations. The question is whether the testosterone-lowering effect, as well as these side effects, are dose dependent.
      Objective: To assess the lowest effective dose of CPA in trans women to prevent side effects.
      Methods: This longitudinal study, conducted at gender identity centers in Amsterdam, Ghent, and Florence, is part of the European Network for the Investigation of Gender Incongruence (ENIGI), a multicenter prospective cohort study. Participants were trans women (n = 882) using estrogens only or in combination with 10, 25, 50, or 100 mg CPA daily. The primary outcome measure was the concentration of testosterone at 3 and/or 12 months of hormone therapy.
      Results: Using estrogens only (without CPA) led to testosterone concentrations of 5.5 nmol/L (standard error of the mean [SEM] 0.3). All doses of CPA resulted in testosterone concentrations below the predefined threshold of suppression of 2 nmol/L (10 mg, 0.9 nmol/L, SEM 0.7; 25 mg, 0.9 nmol/L, SEM 0.1; 50mg, 1.1 nmol/L, SEM 0.1; 100 mg, 0.9 nmol/L, SEM 0.7). Higher prolactin and lower high-density lipoprotein concentrations were observed with increasing doses of CPA. No differences in liver enzyme concentrations were found between the doses.
      Conclusion: Compared with higher doses of CPA, a daily dose of 10 mg is equally effective in lowering testosterone concentrations in trans women, while showing fewer side effects.
      (© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society.)
    • Comments:
      Comment in: J Clin Endocrinol Metab. 2022 Jun 16;107(7):e3094. (PMID: 35293997)
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    • Contributed Indexing:
      Keywords: anti-androgen; cyproterone acetate; hormone therapy; testosterone; trans people
    • Accession Number:
      0 (Androgen Antagonists)
      4KM2BN5JHF (Cyproterone Acetate)
    • Publication Date:
      Date Created: 20210614 Date Completed: 20211207 Latest Revision: 20220727
    • Publication Date:
      20221213
    • Accession Number:
      PMC8571811
    • Accession Number:
      10.1210/clinem/dgab427
    • Accession Number:
      34125226