Dose and feasibility of testosterone in transgender wome

Phase 1

• Conditions: ow testosterone levels in transgender women who underwent a vaginoplasty. We will investigate the serum testosterone levels at different doses of testosteron gel and if there are side effects.; Therapeutic area: Body processes [G] - Physiological processes [G07]

• Registration Number: EUCTR2021-005344-30-NL
• Lead Sponsor: Amsterdam UMC, location VUmc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-27
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 10

Inclusion Criteria

-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

Exclusion Criteria

-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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified