Effect of spironolactone and cyproterone acetate on breast growth in transgender people: a randomized clinical trial.

Lachlan M Angus,Shalem Y Leemaqz,Anna K Kasielska-Trojan,Maksym Mikołajczyk,James C G Doery,Jeffrey D Zajac,Ada S Cheung
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Abstract

CONTEXT Transgender people with sex recorded male at birth desiring feminization commonly use cyproterone acetate or spironolactone as anti-androgens with estradiol, but the optimal anti-androgen is unclear. OBJECTIVE To assess the effect of anti-androgens on breast development. We hypothesized this would be greater in those treated with cyproterone acetate than spironolactone due to more potent androgen receptor antagonism and suppression of serum total testosterone concentrations. DESIGN Randomised clinical trial 2020-2022. SETTING Outpatient endocrinology clinic. PARTICIPANTS Transgender people aged 18+ years old commencing feminizing gender affirming hormone therapy. INTERVENTIONS Standardized estradiol therapy plus either spironolactone 100mg daily or cyproterone acetate 12.5mg daily for six months. MAIN OUTCOME MEASURES Primary outcome was breast development as measured by the breast chest distance. Secondary outcomes included estimated breast volume, suppression of serum total testosterone concentration <2nmol/L and Gender Preoccupation and Stability Questionnaire (GPSQ). RESULTS Sixty-three people (median age 25 years) were enrolled, randomized and included in intention-to-treat analysis (cyproterone acetate n=32, spironolactone n=31). At six months, there was no between-group difference in breast chest distance (mean difference 0.27 cm, 95% CI -0.82 to 1.35, p=0.6) or estimated breast volume (mean difference 17.26 mL, 95% CI -16.94 to 51.47, p=0.3). Cyproterone acetate was more likely to suppress serum testosterone concentration to <2 nmol/L (odds ratio 9.01, 95% CI 1.83 to 4.44, p=0.008). Changes in GPSQ were similar between groups. CONCLUSION Anti-androgen choice should be based on clinician and patient preference with consideration of side effects. Further research is needed to optimize breast development in transgender people.
螺内酯和醋酸环丙孕酮对变性人乳房发育的影响:随机临床试验。
目的评估抗雄激素对乳房发育的影响。我们假设,由于醋酸环丙孕酮具有更强的雄激素受体拮抗作用并能抑制血清总睾酮浓度,因此与螺内酯相比,醋酸环丙孕酮对乳房发育的影响更大。干预措施标准化雌二醇疗法加螺内酯 100 毫克/天或醋酸环丙孕酮 12.5 毫克/天,为期 6 个月。主要结局测量主要结局为乳房发育,以乳房胸距测量。次要结果包括估计乳房体积、抑制血清总睾酮浓度<2nmol/L和性别关注与稳定性问卷(GPSQ)。结果63人(中位年龄25岁)被纳入随机治疗,并进行了意向治疗分析(醋酸环丙孕酮32人,螺内酯31人)。6个月时,乳房胸距(平均差异为0.27厘米,95% CI为-0.82至1.35,P=0.6)或估计乳房体积(平均差异为17.26毫升,95% CI为-16.94至51.47,P=0.3)在组间无差异。醋酸环丙孕酮更有可能将血清睾酮浓度抑制到 <2 nmol/L(几率比 9.01,95% CI 1.83 至 4.44,p=0.008)。结论 抗雄激素的选择应基于临床医生和患者的偏好,并考虑副作用。要优化变性人的乳房发育,还需要进一步的研究。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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