Sublingual estradiol alone versus oral estradiol with cyproterone acetate for the initial treatment of transgender women seeking gender-affirming-hormonal-therapy

Not Applicable

Completed

• Conditions: Gender-affirming-hormone therapy in treatment-naive transgender women; Nutritional, Metabolic, Endocrine

• Registration Number: ISRCTN15726488
• Lead Sponsor: Tel Aviv Sourasky Medical Center

Brief Summary

2023 Results article in https://pubmed.ncbi.nlm.nih.gov/38130980/ (added 13/09/2024)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-08-01
• Study Start: 2024-09-16
• Last Update Posted: 30 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 22

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 Center2. Willing to participate in the study 3. Mentally capable of giving informed consent

Exclusion Criteria

1. A history of chronic liver or kidney disease, GFR=60 ml/min2. Hypertriglyceridemia>300 mg/dl3. Primary hypogonadism as evidenced by below-normal serum testosterone and elevated gonadotropins4. A history of malignancy in the preceding 5 years5. Use of CYP3A4 inducers (phenytoin, rifampin) or inhibitors (ketoconazole, clotrimazole or retroviral drugs such as ritonavir)6. Smoking 7. Drug or alcohol abuse8. Previous history of suicide attempt

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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) questionnaire2. Libido measured using the Sexual Desire Inventory (SDI) questionnaire3. Sexual function measured using the International Index of Erectile Function (IIEF) questionnaire4. 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 months5. 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