Gender Dysphoria (Female-to-male transsexuals and male-to-female transsexuals)
Conditions
Interventions
Trade Name: Nebido
Pharmaceutical Form: Injection
INN or Proposed INN: TESTOSTERONE UNDECANOATE
CAS Number: 5949-44-0
Other descriptive name: TESTOSTERONE UNDECANOATE
Concentration unit: mg/ml milligr
Sponsors
Medical University of Vienna, Department of Psychiatry and Psychotherapy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • DSM-5 diagnosis of Gender Dysphoria (DSM-5: 302.85; ICD-10: F64.1) • Somatic health based on history, physical examination, ECG, laboratory screening, SCID • willingness and competence to sign the informed consent form 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 92 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • concomitant major medical or neurological illness • internal or neurologic medical histories as well as pregnancy (positive urine pregnancy test) or breastfeeding • other DSM-5 Axis-I comorbidities, determined by a structured clinical interview (SCID), especially body dysmorphic disorder (DSM-5: 300.7; ICD-10: F45.22), schizophrenia spectrum and other psychotic disorders. • steroid hormone treatment within 6 months prior to inclusion. • treatment with psychotropic agents such as SSRIs • any implant or stainless steel graft which poses contraindication for MRI • clinically relevant abnormal values in routine laboratory screening or general physical examination • current substance abuse or current or past substance related disorder • for participants who participated in an earlier neuroimaging study using ionizing radiation, the total radiation exposure dose of 30 mSv over the last 10 years must not be exceeded, as specified in the legislation on radiation protection (Allg. Strahlenschutzverordnung 2010; www.ris.bka.gv.at). • failure to comply with the study protocol or to follow the instructions of the investigating team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. To examine the influence of high-dose, long-term opposite-sex hormone treatment on serotonin synthesis in FtM and MtF transsexuals using the radiotracer [11C]5-HTP. 2. To examine the influence of high-dose, long-term opposite-sex hormone treatment on serotonin degradation in FtM and MtF transsexuals using the radiotracer [11C]harmine.;Secondary Objective: 1. To examine the influence of high-dose, long-term opposite-sex hormone treatment on brain structure, brain function and CBF in combination with the PET data by using MR. 2. To examine the influence of high-dose, long-term opposite-sex hormone treatment on RNA expression and 3. To examine differences between transsexuals and healthy controls in gene polymorphisms 4. To examine the influence of genotype on the effects of hormone treatment 5. To probe differences between transsexuals and healthy control subjects with regards to above mentioned endpoints. ;Primary end point(s): - Net plasma-to-brain uptake constant (K*, in mL/g per minute) for [11C]AMT - Distribution volumes of specifically bound radioligand (DVs) for [11C]harmine;Timepoint(s) of evaluation of this end point: - baseline (within 2 weeks before start of treatment) - 4 months after treatment start | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): MRI endpoints (BOLD response, DTI measures (FA, MD, AD, RD), structural measures (GMV, GMD), CBF, MR-spectroscopy);Timepoint(s) of evaluation of this end point: before treatment and 4 months after treatment start | — |
Countries
Austria
Contacts
Public ContactUniversitätsklinik für Psychiatrie
Medical University of Vienna
Outcome results
None listed