NCT01065220

Brief Summary

The aim of this study is to prove the influence of the sex steroid hormones estrogen, progesterone and testosterone on the serotonin transporter (5-HTT) binding using positron emission tomography (PET) and the selective radioligand \[11C\]DASB. Specifically, the 5-HTT binding will be quantified before and after hormone therapy underwent by 10 male-to-female (MtF) and 10 female-to-male (FtM) transsexuals urging for hormone treatment. The high-level, long-term administration of opsite sex steroid hormones in transsexuals provide the unique opportunity to investigate the influence of sex steroid hormones on the serotonergic system. Since the serotonin transporter serves as a primary target molecule for antidepressant treatment, the results of the study will be of benefit for the assessment of the clinical relevance of estrogen and testosterone as modulatory and neuroactive agents.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2010

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

February 8, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 9, 2010

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

3.9 years

First QC Date

February 8, 2010

Last Update Submit

January 2, 2014

Conditions

Transsexualism

Keywords

Serotonin TransporterHormone therapyGender DysphoriaTranssexualism

Outcome Measures

Primary Outcomes (1)

  • change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography

    The serotonin-transporter BP will be assessed in a 90 min. dynamic PET measurement session at three timepoints: before start of hormonal therapy, after four weeks of hormonal therapy, and after 4 months of hormonal therapy

    5 months

Study Arms (2)

hormone treatment for MtF

EXPERIMENTAL

* cyproterone acetate * estradiol * alpha-5-reductase-inhibitor

Drug: Cyproterone AcetateDrug: EstradiolDrug: 5-alpha reductase inhibitor

hormone treatment for FtM

EXPERIMENTAL

* testosterone undecanoate * lynestrenol

Drug: Testolactone undecanoateDrug: Lynestrenol

Interventions

Testolactone undecanoateDRUG

4ml i.m.

Also known as: Nebido®
hormone treatment for FtM
LynestrenolDRUG

2/day

Also known as: Orgametril®
hormone treatment for FtM
Cyproterone AcetateDRUG

50mg per day

Also known as: Androcur®
hormone treatment for MtF
EstradiolDRUG

100 microgram TTS twice a week

Also known as: Estradot®
hormone treatment for MtF
5-alpha reductase inhibitorDRUG

1mg daily

Also known as: Finasterid®
hormone treatment for MtF

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • somatic health
  • no previous sex hormone medication
  • willingness to sign the written informed consent

You may not qualify if:

  • severe diseases
  • treatment with psychotropic agents such as selective serotonin reuptake inhibitors (SSRIs)
  • any implant or stainless steel graft
  • positive urine pregnancy test in women at the screening visit at each PET day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, A-1090, Austria

Location

Related Publications (1)

  • Kranz GS, Wadsak W, Kaufmann U, Savli M, Baldinger P, Gryglewski G, Haeusler D, Spies M, Mitterhauser M, Kasper S, Lanzenberger R. High-Dose Testosterone Treatment Increases Serotonin Transporter Binding in Transgender People. Biol Psychiatry. 2015 Oct 15;78(8):525-33. doi: 10.1016/j.biopsych.2014.09.010. Epub 2014 Sep 23.

    PMID: 25497691DERIVED

MeSH Terms

Conditions

TranssexualismGender Dysphoria

Interventions

testosterone undecanoateLynestrenolCyproterone AcetateEstradiol5-alpha Reductase Inhibitors

Condition Hierarchy (Ancestors)

SexualitySexual BehaviorBehaviorSexual Dysfunctions, PsychologicalMental Disorders

Intervention Hierarchy (Ancestors)

NorpregnenesNorpregnanesNorsteroidsSteroidsFused-Ring CompoundsPolycyclic CompoundsCyproteronePregnadienesPregnanesSteroids, ChlorinatedEstrenesEstranesEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsSteroid Synthesis InhibitorsEnzyme InhibitorsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesHormone AntagonistsPhysiological Effects of Drugs

Study Officials

  • Rupert Lanzenberger, MD A/Prof

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
A/Prof. PD Dr.

Study Record Dates

First Submitted

February 8, 2010

First Posted

February 9, 2010

Study Start

February 1, 2010

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations

AU(1)