Gender-affirming-hormone therapy in treatment-naive transgender women Nutritional, Metabolic, Endocrine
Conditions
Interventions
Self-allocation to the protocol arm by participants to either oral estradiol 2 mg once daily combined with 10 mg of the antiandrogen cyproterone acetate, or 2 mg daily estradiol divided into 4 doses,
Sponsors
Tel Aviv Sourasky Medical Center
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Treatment-naive transgender women aged 18 years and older seeking gender-affirming therapy (GAHT), at the Transgender Health Center Clinic within the Institute of Endocrinology and Metabolism at Tel Aviv-Sourasky Medical Center 2. Willing to participate in the study 3. Mentally capable of giving informed consent
Exclusion criteria
Exclusion criteria: 1. A history of chronic liver or kidney disease, GFR=60 ml/min 2. Hypertriglyceridemia>300 mg/dl 3. Primary hypogonadism as evidenced by below-normal serum testosterone and elevated gonadotropins 4. A history of malignancy in the preceding 5 years 5. Use of CYP3A4 inducers (phenytoin, rifampin) or inhibitors (ketoconazole, clotrimazole or retroviral drugs such as ritonavir) 6. Smoking 7. Drug or alcohol abuse 8. Previous history of suicide attempt
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Testosterone concentration measured using an electro-chemiluminescence assay (COBAS 6000, e 691 modules,113 Roche, Switzerland), at baseline before treatment, and at the end of the study after 6 months of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| The following secondary outcome measures were assessed at baseline and after 6 months unless stated: 1. Gender dysphoria measured using the Gender Dysphoria and Life Satisfaction (GCLS) questionnaire 2. Libido measured using the Sexual Desire Inventory (SDI) questionnaire 3. Sexual function measured using the International Index of Erectile Function (IIEF) questionnaire 4. Safety measures consisted of an array of biochemical (on an Advia Centaur XP autoanalyzer, Siemens, 110 Germany), hematological (on a Beckman Coulter Counter, IN, USA), and hormonal laboratory (on the Immulite® 2000, Siemens, Germany) variables, drawn at baseline, 3 months, and 6 months 5. Body composition measured using DXA (Lunar Prodigy system, GE Healthcare, Chicago, IL), and by BIA (InBody 770 body composition analyzer, InBody Co., Ltd, Seoul, Korea) at baseline and 6 months | — |
Countries
Israel
Contacts
Public ContactKaren Tordjman
Outcome results
None listed