gender-affirming hormone treatment Hypogonadism
Conditions
Interventions
During the study, participants will receive 2% transdermal testosterone gel
(Tostran®) daily. During the dose-titration phase, participants will receive
daily doses of 2% transdermal testosterone ge
Sponsors
Universitair Medisch Centrum
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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 one year - Underwent vaginoplasty - Sufficient knowledge of the Dutch language - BMI 18-30 kg/m2 - Testosterone levels
Exclusion criteria
Exclusion criteria: - No regular follow-up visits at the clinic for gender dysphoria - Previous use of testosterone therapy - Current treatment for 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 - Hematocrit at last visit prior to baseline of >0.49 l/l - 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 (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To establish dose-response relationship, the main study parameters are the testosterone levels at different daily dosages of 2.5 mg (1/4th pump), 3.3 mg (1/3rd pump) and 5 mg (1/2nd pump) at the short-term (minimum 2 weeks) and after two months of continuous use. When testosterone levels between 1.5 and 2.5 nmol/l have been reached, the participants will continue on that dose for two months in which testosterone levels are determined every month. At each visit, changes in symptoms of androgenism are assessed which include facial and bodily hair growth, alopecia, acne and application site symptoms. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the evaluation of a clinical symptoms questionnaire to assess the expected effects of changes in serum testosterone concentrations. Finally, for participants who wish to participate in the elective part of the study, feasibility of measuring changes in vaginal pulse amplitude (VPA) will be assessed using photoplethysmography during different erotic stimuli. | — |
Countries
Netherlands
Outcome results
None listed