Sex Steroids and the Serotonin Transporter

January 2, 2014 updated by: Rupert Lanzenberger, Medical University of Vienna

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Vienna, Austria, A-1090
        • Department of Psychiatry and Psychotherapy, Medical University of Vienna

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: hormone treatment for MtF
  • cyproterone acetate
  • estradiol
  • alpha-5-reductase-inhibitor
Drug: Cyproterone Acetate
50mg per day
Other Names:
  • Androcur®
Drug: Estradiol
100 microgram TTS twice a week
Other Names:
  • Estradot®
Drug: 5-alpha reductase inhibitor
1mg daily
Other Names:
  • Finasterid®
Experimental: hormone treatment for FtM
  • testosterone undecanoate
  • lynestrenol
Drug: Testolactone undecanoate
4ml i.m.
Other Names:
  • Nebido®
Drug: Lynestrenol
2/day
Other Names:
  • Orgametril®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Vienna

Investigators

  • Principal Investigator: Rupert Lanzenberger, MD A/Prof, Medical University of Vienna

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

January 3, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AP13214ONB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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