Effects of Sex Steroids on the Serotonin System

NCT02715232 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2018-10-15

No results posted yet for this study

Summary

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.

Conditions

  • Gender Dysphoria

Interventions

DRUG

Testosterone

100mg testosterone undecanoat every 8-12 weeks, or alternatively 50mg testosterone transdermally, or 50mg testosterone creme

DRUG

Lynestrenol

2-3 tablets/day, if menstruation still occurs

DRUG

Cyproterone Acetate

25mg daily

DRUG

Estradiol

75 microgram transdermal therapeutic system twice a week, or p.o. estradiol 2x2mg/day, or estradiol gel 1,5-3mg

DRUG

Triptorelin acetate

4,12mg every 4-6 weeks (powder for suspension for injection s.c. or i.m.

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Rupert Lanzenberger, MD · Department of Psychiatry and Psychotherapy, Medical University of Vienna

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-02-06
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02715232 on ClinicalTrials.gov