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Safety of gender affirming treatment in assigned female at birth transgender people and association of androgen and estrogen β receptor polymorphisms with clinical outcomes

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Abstract

Purpose

Gender affirming hormone treatment (GAHT) with androgens in assigned female at birth (AFAB) people with Gender Incongruence (GI) can induce and maintain variable phenotypical changes, but individual response may be genetically determined. To clarify the role of AR and ERβ polymorphisms we prospectively evaluated AFAB subjects undergoing virilizing GAHT.

Methods

Fifty-two AFAB people with confirmed GI were evaluated before (T0) and after 6 (T6) and 12 months (T12) of testosterone enanthate 250 mg i.m. every 28 days. Hormone profile (testosterone, estradiol), biochemical (blood count, glyco-metabolic profile) and clinical parameters (Ferriman-Gallwey score, pelvic organs) were evaluated at each time-point, as well as number of CAG and CA repeats for AR and ERβ, respectively.

Results

All subjects have successfully achieved testosterone levels within normal male ranges and improved their degree of virilization, in absence of significant side effects. Hemoglobin, hematocrit and red blood cells were significantly increased after treatment, but within normal ranges. Ultrasound monitoring of pelvic organs showed their significant reduction already after 6 months of GATH, in absence of remarkable abnormalities. Furthermore, a lower number of CAG repeats was associated with a higher Ferriman-Gallwey score post treatment and a higher number of CA repeats was associated with uterine volume reduction.

Conclusion

We confirmed safety and efficacy of testosterone treatment on all measured parameters. This preliminary data hints a future role of genetic polymorphisms to tailor GAHT in GI people, but evaluation on a larger cohort is necessary as the reduced sample size could limit data generalization at this stage.

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Data availability

The data presented in this study are available upon reasonable request from the corresponding author.

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Funding

This research was funded by the Italian Ministry of University and Research MUR-PRIN (Grant Number MIUR-PRIN 2017FC4BS9).

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Authors and Affiliations

  1. Laboratory of Seminology – Sperm Bank “Loredana Gandini”, Department of Experimental Medicine, “Sapienza” University of Rome, 00161, Rome, Italy

    Francesco Pallotti, Giulia Senofonte, Anna Chiara Conflitti, Antonella Anzuini, Enrico Delli Paoli, Silvia Di Chiano, Fabiana Faja, Francesco Lombardo & Donatella Paoli

  2. Faculty of Medicine and Surgery, University of Enna “Kore”, 94100, Enna, Italy

    Francesco Pallotti

  3. Prenatal Diagnosis Centre, Department of Obstetrics, Gynaecology and Urologic Science, “Sapienza” University of Rome, 00161, Rome, Italy

    Antonella Giancotti, Alessandro Mondo & Lorenzo Spiniello

  4. Department of Psychological Health and Territorial Sciences, School of Medicine and Health Sciences, “G. d’Annunzio” University of Chieti-Pescara, 66100, Chieti, Italy

    Valentina Gatta

  5. Unit of Molecular Genetics, Center for Advanced Studies and Technology (CAST), “G. d’Annunzio” University of Chieti-Pescara, 66100, Chieti, Italy

    Valentina Gatta

  6. Gender Identity Development Service, Hospital S. Camillo-Forlanini, 00152, Rome, Italy

    Maddalena Mosconi

  7. Section of Medical Pathophysiology and Endocrinology, Department of Experimental Medicine, Sapienza University of Rome, 00161, Rome, Italy

    Flavio Rizzo

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  1. Francesco Pallotti
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Contributions

F.P., F.L., and D.P. contributed to the study conception and design. Data collection and analyses were performed by D.P., A.G., A.C.C., A.A., E.D.P., S.D.C., F.F., A.M., F.R., and L.S. The first draft of the manuscript was written by F.P. and G.S. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript. D.P., F.L., V.G., A.G., and M.M. critically reviewed the manuscript. All authors read and approved the final manuscript.

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Correspondence to Francesco Pallotti.

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The study was conducted in accordance with the Declaration of Helsinki and approved by Ethics Committee “Sapienza” (Prot. 1057/2021, date of approval 30/11/2021).

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Pallotti, F., Senofonte, G., Conflitti, A.C. et al. Safety of gender affirming treatment in assigned female at birth transgender people and association of androgen and estrogen β receptor polymorphisms with clinical outcomes. Endocrine 81, 621–630 (2023). https://doi.org/10.1007/s12020-023-03421-8

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