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Sex Steroids and the Serotonin Transporter

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rupert Lanzenberger, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01065220
First received: February 8, 2010
Last updated: January 2, 2014
Last verified: January 2014

February 8, 2010
January 2, 2014
February 2010
January 2014   (final data collection date for primary outcome measure)
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
serotonin-transporter binding potential [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01065220 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Sex Steroids and the Serotonin Transporter
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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Transsexualism
  • Drug: Testolactone undecanoate
    4ml i.m.
    Other Name: Nebido®
  • Drug: Lynestrenol
    2/day
    Other Name: Orgametril®
  • 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 MtF
    • cyproterone acetate
    • estradiol
    • alpha-5-reductase-inhibitor
    Interventions:
    • Drug: Cyproterone Acetate
    • Drug: Estradiol
    • Drug: 5-alpha reductase inhibitor
  • Experimental: hormone treatment for FtM
    • testosterone undecanoate
    • lynestrenol
    Interventions:
    • Drug: Testolactone undecanoate
    • Drug: Lynestrenol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
32
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 55 Years
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01065220
AP13214ONB
Yes
Rupert Lanzenberger, Medical University of Vienna
Medical University of Vienna
Not Provided
Principal Investigator: Rupert Lanzenberger, MD A/Prof Medical University of Vienna
Medical University of Vienna
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP