Chapter 3 74 study id. 2019.353). For the RESTED study, approval for participation was obtained by the local ethical committee of the UMCG. All participants provided informed consent. 2.2. Participants Participants in both studies were included if they were going to start GAHT at one of the participating centers if they could speak, read and write Dutch, and if they were 18 years or older. For the RESTED study, participants were not included if they had used GAHT before, if they had been diagnosed with sleep disorders, were using benzodiazepines or opiates, or if they were aged over 50 years. Since previous use of GAHT was not an exclusion criterion for participation in the ENIGI cohort study, we excluded ENIGI participants who were not hormone-naïve (e.g. had previously used GAHT or were already using GAHT; n=7) from the current study database. The baseline sample of ENIGI in this study was n=198, and the baseline sample of the RESTED cohort was n=97. Participants could participate in both studies, as displayed in Figure 3.1. If individuals participated in both studies, duplicate measurements were removed. Due to the ongoing character of both cohort studies and loss to follow-up, sample sizes differ at each measurement time point. 2.3. Gender-affirming hormone therapy To accurately reflect the grouping of participants, as recommended by Peters et al. (2023), we split the participant groups by GAHT formulations. Masculinizing hormones for TM participants were administered in the form of transdermal testosterone (daily dose of 40.5 mg) or intramuscular testosterone (short-acting testosterone esters, 250 mg every 3 weeks, or long-acting testosterone undecanoate, 1000 mg every 12 weeks). TM participants could also use progestins or combined hormonal contraceptives to suppress menstrual cycles. It should be noted that in the participating centers, gonadotropin-releasing hormone (GnRH) analogs were not used to suppress endogenous hormone production in the TM group.
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