TETRA-pilot: Testosterone in transgender women after vaginoplasty: a dose-finding and feasibility pilot study - TETRA-pilot

Amsterdam UMC, location VUmc0 个研究点目标入组 10 人开始时间: 2022年5月27日最近更新: 2023年9月18日

试验速览

暂无简介。

•-Start of gender affirming hormone therapy at or after 18 years of age
•-Current use of estradiol therapy with good compliance for at least six months
•-Underwent vaginoplasty at least 6 months ago
•-Sufficient knowledge of the Dutch language
•-BMI 18-35 kg/m2
•-Testosterone levels <0.8 nmol/l measured since vaginoplasty
•-To participant in optional vaginal pulse amplitude measurement: minimal self-reported vaginal depth of five centimeters
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-No regular follow-up visits at the clinic for gender dysphoria in the past four years
•-Current use of testosterone therapy
•-Current untreated clinical depression
•-Severe familial dyslipidemia (e.g. Familial Hypercholesterolemia)
•-Serum estradiol concentration lower than 150 pmol/l or higher than 700 pmol/L the VUmc reference range (150-700 pmol/L) at last visit prior to baseline.
•-Mental health issues that prevent participation
•-Current use of anticoagulation treatment or corticosteroids
•-Any of the following contraindications for the use of testosterone gel (Tostran®): Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours (e.g genital tract carcinoma); Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal (<2.5xULN); Porphyria; Cerebral hemorrhage; Known hypersensitivity to the active substances or to any of the excipients (Propylene glycol, Ethanol anhydrous, Isopropyl alcohol, Oleic acid, Carbomer 1382, Trolamine, Butylhydroxytoluene (E321), Hydrochloric acid (used for pH adjustment)); Interfering medication (SPC).

发起方

Amsterdam UMC, location VUmc