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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01065220
Other study ID # AP13214ONB
Secondary ID
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


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
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