Skip to main content
OpenTrials
Completed

NCT Number: NCT01065220

Sex Steroids and the Serotonin Transporter

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Transsexualism Behavior Gender Dysphoria Mental Disorders Sexual Behavior Sexual Dysfunctions, Psychological Sexuality

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, A-1090, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • severe diseases
  • steroid hormone treatment within 6 months prior inclusion
  • 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

Treatment and study plan

Testolactone undecanoate

Drug

4ml i.m.

Other names: Nebido®

Lynestrenol

Drug

2/day

Other names: Orgametril®

cyproterone acetate

Drug

50mg per day

Other names: Androcur®

Estradiol

Drug

100 microgram TTS twice a week

Other names: Estradot®

5-Alpha Reductase Inhibitor

Drug

1mg daily

Other names: Finasterid®

Primary outcomes

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

    Time frame: 5 months

    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

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 9, 2010
Registry last updated
Jan 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.