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Trial · Interventional

Status unknownPhase 4Registry data

Effects of Sex Steroids on the Serotonin System

NCTNCT02715232 (opens ClinicalTrials.gov in a new tab)Other id1.1-20150511
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Overview

Status
Status unknown
Phase
Phase 4
Enrollment
92 participants (estimated)
Sponsor
Medical University of Vienna · Other
Design
Not randomized · Open label (no masking)
Countries
1 country

Austria

Start
6 Feb 2017
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
First posted
22 Mar 2016 (estimated)
Last update posted
15 Oct 2018
Conditions
Gender Dysphoria

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20172018201920202021
  1. Ph 4

    Effects of Sex Steroids on the Serotonin System

    NCT02715232

    6 Feb 2017 to est. Dec 2020

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The aim of this study is to prove the modulatory influence of sex hormones on serotonergic neurotransmission by determining the enzymatic processes involved in serotonin synthesis and degradation using positron emission tomography (PET) in humans in vivo with the radiotracers \[11C\]AMT and \[11C\]harmine.

Interventions

  • TestosteroneDrug
  • LynestrenolDrug
  • Cyproterone AcetateDrug
  • EstradiolDrug
  • Triptorelin acetateDrug

Arms4

  • Experimental

    Female-to-Males

    Female-to-Male Transsexuals receiving Testosterone treatment

  • Experimental

    Male-to-Females

    Male-to-Female Transsexuals receiving Estradiol and Anti-androgen treatment

  • No intervention

    Female Controls

    Female Controls receiving no intervention

  • No intervention

    Male Controls

    Male controls receiving no intervention

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. blood-to-brain clearance/trapping (K*) of [11C]AMT

    Time frame · <5 months

    Registry description

    \[11C\]AMT trapping as an estimation of brain serotonin synthesis in vivo in humans

  2. distribution volume (DV) of [11C]harmine

    Time frame · <5 months

    Registry description

    distribution volume of specifically bound radioligand \[11C\]harmine in brain regions

Secondary outcomes(5)

  1. white and gray matter microstructure

    Time frame · <5 months

    Registry description

    microstructure measured using diffusion weighted imaging

  2. gray matter volume/density and cortical thickness

    Time frame · <5 months

    Registry description

    structural MRI measurements

  3. cerebral blood flow (CBF)

    Time frame · <5 months

    Registry description

    cerebral blood flow measured using arterial spin labeling MRI

  4. Scores on the Klein Sexual Orientation Grid (KSOG)

    Time frame · <5 months

    Registry description

    the KSOG measures sexual orientation

  5. Scores on the Utrecht Gender Dysphoria Scale

    Time frame · <5 months

    Registry description

    Score for gender dysphoria

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedKlobl M, Reed MB, Handschuh P, Kaufmann U, Konadu ME, Ritter V, Spurny-Dworak B, Kranz GS, Lanzenberger R, Spies M. Gender Dysphoria and Sexual Euphoria: A Bayesian Perspective on the Influence of Gender-Affirming Hormone Therapy on Sexual Arousal. Arch Sex Behav. 2024 May;53(5):1859-1871. doi: 10.1007/s10508-023-02778-1. Epub 2024 Jan 12. PMID 38216784

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * DSM-5 diagnosis of Gender Dysphoria (DSM-5: 302.85; ICD-10: F64.1) (for transsexuals only) * Somatic health based on history, physical examination, ECG, laboratory screening, SCID * willingness and competence to sign the informed consent form 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 dysphoric 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 * 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 20 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

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