Sex Steroids and the Serotonin Transporter

Transsexualism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01065220
• Other study ID #: AP13214ONB
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2010
• Last updated: January 2, 2014
• Start date: February 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Transsexualism

Intervention

Drug:
• Testolactone undecanoate
4ml i.m.
• Lynestrenol
2/day
• Cyproterone Acetate
50mg per day
• Estradiol
100 microgram TTS twice a week
• 5-alpha reductase inhibitor
1mg daily

Locations

Country	Name	City	State
Austria	Department of Psychiatry and Psychotherapy, Medical University of Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No