Sex Steroids and the Serotonin Transporter

Phase 4

Completed

• Conditions: Transsexualism
• Interventions: Drug: Testolactone undecanoate; Drug: Cyproterone Acetate; Drug: Estradiol; Drug: Lynestrenol; Drug: 5-alpha reductase inhibitor

• Registration Number: NCT01065220
• Lead Sponsor: Medical University of Vienna

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-09
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-02
• Last Update Posted: 2014-01-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• somatic health
• no previous sex hormone medication
• willingness to sign the written informed consent

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hormone treatment for MtF	5-alpha reductase inhibitor	* cyproterone acetate * estradiol * alpha-5-reductase-inhibitor
hormone treatment for FtM	Testolactone undecanoate	* testosterone undecanoate * lynestrenol
hormone treatment for MtF	Cyproterone Acetate	* cyproterone acetate * estradiol * alpha-5-reductase-inhibitor
hormone treatment for MtF	Estradiol	* cyproterone acetate * estradiol * alpha-5-reductase-inhibitor
hormone treatment for FtM	Lynestrenol	* testosterone undecanoate * lynestrenol

Primary Outcome Measures

Name	Time	Method
change in serotonin-transporter binding potential (BP) in predefined brain regions, measured by Positron Emission Tomography	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

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, Medical University of Vienna; 🇦🇹 Vienna, Austria