ISSN 1662-4009 (online)

ESPE Yearbook of Paediatric Endocrinology (2019) 16 6.1 | DOI: 10.1530/ey.16.6.1

ESPEYB16 6. DSD and Gender Dysphoria DSD New Paradigm (1 abstracts)

6.1. Oestrogen versus androgen in hormone-replacement therapy for complete androgen insensitivity syndrome: a multicentre, randomised, double-dummy, double-blind crossover trial

Birnbaum W , Marshall L , Werner R , Kulle A , Holterhus PM , Rall K , Köhler B , Richter-Unruh A , Hartmann MF , Wudy SA , Auer MK , Lux A , Kropf S & Hiort O



Lancet Diabetes Endocrinol. 2018 Oct;6(10):771–780.

doi: 10.1016/S2213-8587(18)30197-9.

For the first time a prospective randomized treatment study has been performed for individuals with a DSD. This national multi-center, double-blind, randomized, cross-over trial compared estrogen therapy to androgen replacement in complete androgen insensitivity syndrome (CAIS).

Initially 26 women with CAIS were included, but 10 withdrew or dropped-out, leaving n=16. Participants received either estradiol 1.5 mg/day for 6 months and then testosterone 50 mg/day for 6 months, or the reverse order. A run-in period with estrogen treatment was the same for both groups. The primary outcome was health related quality of life (measured by the questionnaire SF-36). Secondary outcomes were psychological well-being and sexual function.

Estrogen had a positive effect on mental health, and ameliorated psychological distress. Testosterone significantly improved sexual function, especially scores in the desire, arousal, lubrication, and orgasm domains. However, the total score remained in the range of low sexual function during both treatments. The mechanism for this testosterone effect is not clear, but the authors suggest that it could be due to local conversion to estradiol or 3alfa-androstandediol in the central nervous system.

Patients and patient organisations have stated for several years that gonadectomy causes a definite negative change in wellbeing and sexual function. This study answers some of the issues that have been debated, by showing that women with CAIS can benefit from androgen treatment. It is possible that higher doses or combination treatment with both hormones may result in more optimal outcomes in the longer perspective.

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