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

Phase 2

Completed

• Conditions: gender-affirming hormone treatment; Hypogonadism; 10014701

• Registration Number: NL-OMON51335
• Lead Sponsor: niversitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• 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 one year
- Underwent vaginoplasty
- Sufficient knowledge of the Dutch language
- BMI 18-30 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

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 (<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
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To establish dose-response relationship, the main study parameters are the<br /><br>testosterone levels at different daily dosages of 2.5 mg (1/4th pump), 3.3 mg<br /><br>(1/3rd pump) and 5 mg (1/2nd pump) at the short-term (minimum 2 weeks) and<br /><br>after two months of continuous use. When testosterone levels between 1.5 and<br /><br>2.5 nmol/l have been reached, the participants will continue on that dose for<br /><br>two months in which testosterone levels are determined every month. At each<br /><br>visit, changes in symptoms of androgenism are assessed which include facial and<br /><br>bodily hair growth, alopecia, acne and application site symptoms. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints include the evaluation of a clinical symptoms questionnaire<br /><br>to assess the expected effects of changes in serum testosterone concentrations.<br /><br>Finally, for participants who wish to participate in the elective part of the<br /><br>study, feasibility of measuring changes in vaginal pulse amplitude (VPA) will<br /><br>be assessed using photoplethysmography during different erotic stimuli. </p><br>