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Sex Steroids and the Serotonin Transporter

This study is currently recruiting participants.
Verified January 2013 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01065220
First received: February 8, 2010
Last updated: January 24, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Transsexualism
 Drug: Testolactone undecanoate
Drug: Lynestrenol
Drug: Cyproterone Acetate
Drug: Estradiol
Drug: 5-alpha reductase inhibitor
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: The Influence of Sex Steroid Hormones on Serotonin Transporter Binding in the Human Brain Investigated by Positron Emission Tomography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography [ Time Frame: 5 months ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 20
Study Start Date: February 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: hormone treatment for MtF
  • cyproterone acetate
  • estradiol
  • alpha-5-reductase-inhibitor
 Drug: Cyproterone Acetate
50mg per day
Other Name: Androcur®
Drug: Estradiol
100 microgram TTS twice a week
Other Name: Estradot®
Drug: 5-alpha reductase inhibitor
1mg daily
Other Name: Finasterid®
Experimental: hormone treatment for FtM
  • testosterone undecanoate
  • lynestrenol
 Drug: Testolactone undecanoate
4ml i.m.
Other Name: Nebido®
Drug: Lynestrenol
2/day
Other Name: Orgametril®

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01065220

Contacts
Contact: Rupert Lanzenberger, MD A/Prof +43-1-40400-3825 rupert.lanzenberger@meduniwien.ac.at
Contact: Siegfried Kasper, MD Prof DDr

Locations
Austria
Department of Psychiatry and Psychotherapy, Medical University of Vienna Recruiting
Vienna, Austria, A-1090
Contact: Siegfried Kasper, MD Prof DDr     +43-1-40400-3568     sci-biolpsy@meduniwien.ac.at    
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Rupert Lanzenberger, MD A/Prof Medical University of Vienna
  More Information

No publications provided

Responsible Party: Rupert Lanzenberger, A/Prof. PD Dr., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01065220     History of Changes
Other Study ID Numbers: AP13214ONB
Study First Received: February 8, 2010
Last Updated: January 24, 2013
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Serotonin Transporter
Hormone therapy
Gender Dysphoria
Transsexualism

Additional relevant MeSH terms:
Transsexualism
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Mental Disorders
Cyproterone
Cyproterone Acetate
Diane
Estradiol
Polyestradiol phosphate
Testolactone
Estradiol valerate
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Lynestrenol
Hormones
 Serotonin
5-alpha Reductase Inhibitors
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Contraceptive Agents, Male
Contraceptive Agents
Reproductive Control Agents
Estrogens
Contraceptive Agents, Female
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on June 18, 2013