Safety and rapid efficacy of guideline-based gender-affirming hormone therapy: an analysis of 388 individuals diagnosed with gender dysphoria

Abstract

Objective Hormone treatment is an important part of gender reassignment therapy in gender dysphoria. Previous data about efficacy and safety are commonly based on small cohorts or they comprise former cohorts under meanwhile obsolete therapy regimes. Our objective was to investigate these topics in a large cohort of individuals under guideline-based treatment. Design/methods Cohort study of medical files of n = 155 male-to-female (transwomen) and n = 233 female-to-male transgender persons (transmen) of an Endocrine outpatient clinic between 2009 and 2017. Results Median time to reach amenorrhoea in transmen under testosterone monotherapy was 3 months, regardless of whether testosterone undecanoat or gel was used. Transmen with higher levels of hemoglobin 3–4 months after onset of GAHT had a greater chance to reach amenorrhea early, whereas testosterone levels showed no significant correlation (hemoglobin: HR: 1.639; 95% CI: 1.036–2.591, P = 0.035; testosterone: HR: 0.999; 95% CI: 0.998–1.001, P = 0.490). Estradiol levels (ρ −0.117; P = 0.316) had no significant influence on breast development in transwomen. Testosterone levels (ρ −0.398; P < 0.001) and FAI (ρ 0.346; P = 0.004) were significantly negatively correlated with reached Tanner stage. Liver values and blood lipids showed an alignment to reference range of the required sex in both groups. Relevant elevations of liver values were rare (2.44% in transmen, 4.23% in transwomen) and transient in most cases. Most relevant side effects were acne (44.8%), respectively erythrocytosis (up to 5.6%) in transmen and venous thrombembolism (1.9%) in transwomen. Conclusions Gender-affirming hormone therapy in accordance with current clinical practice guidelines is efficient and safe.

Relationship Between Serum Estradiol Concentrations and Clinical Outcomes in Transgender Individuals Undergoing Feminizing Hormone Therapy: A Narrative Review

“…Breast development was also analyzed by Meyer et al, who reported a retrospective cohort study involving 155 transgender individuals. 10 Similar to the previous study, the authors also reported breast development by breast-chest difference but also by Tanner stage. Median breast-chest difference measured 8.5 -5 cm and Tanner stage 4 -1 at 3-4 years with estradiol concentration 342 -382 pmol/L.…”

“…47 Importantly, more adequate suppression of serum testosterone concentration has been associated with enhanced breast development as measured by Tanner stage. 10 Similarly, greater changes in body composition are seen in transgender adolescents treated with GnRHa monotherapy than after subsequent commencement of estradiol. 26…”

Geschlechtsangleichende Hormontherapie bei Transidentität: Voraussetzungen und Therapiemanagement

“…Weiterhin werden ein Anstieg der Triglyzeride [26,27] und auch der Leberwerte [6] beschrieben. Auch diese metabolischen Nebenwirkungen scheinen unter Verwendung moderner, transdermaler Estradiolformulationen sehr viel weniger häufig aufzutreten [17,27]. Bislang liegen nur wenige Langzeitdaten zum kardiovaskulären Risiko vor, es konnte jedoch ein vermehrtes Auftreten zerebraler Ischämien im Vergleich zu altersgleichen Frauen (2,4-fach erhöhtes Risiko) und Männern (1,8-fach erhöhtes Risiko) gesehen werden [28].…”

Characteristics of Transgender Women Referred to Women's Heart Clinic

“…[ 1 , 2 , [5] , [6] , [7] , [8] ] Moreover, the evolution of gender-affirming hormone therapy (GAHT) away from use of ethinyl estradiol renders some published data outdated, such that the risk of hard outcomes of CVD conferred by GAHT in older TGD individuals is unknown. [ 3 , [9] , [10] , [11] ] Thus, recommendations put forward by medical societies rely heavily on expert opinion and extrapolation from the cisgender population. [ 12 14 ] For example, regular screening for cardiac risk factors and metabolic changes in transgender persons treated with GAHT is recommended by clinical practice guidelines.…”