Sex Steroids and the Serotonin Transporter

NCT ID: NCT01065220

Last Updated: 2014-01-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2014-01-31

Brief Summary

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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

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Conditions

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Transsexualism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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hormone treatment for MtF

* cyproterone acetate
* estradiol
* alpha-5-reductase-inhibitor

Group Type EXPERIMENTAL

Cyproterone Acetate

Intervention Type DRUG

50mg per day

Estradiol

Intervention Type DRUG

100 microgram TTS twice a week

5-alpha reductase inhibitor

Intervention Type DRUG

1mg daily

hormone treatment for FtM

* testosterone undecanoate
* lynestrenol

Group Type EXPERIMENTAL

Testolactone undecanoate

Intervention Type DRUG

4ml i.m.

Lynestrenol

Intervention Type DRUG

2/day

Interventions

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Testolactone undecanoate

4ml i.m.

Intervention Type DRUG

Lynestrenol

2/day

Intervention Type DRUG

Cyproterone Acetate

50mg per day

Intervention Type DRUG

Estradiol

100 microgram TTS twice a week

Intervention Type DRUG

5-alpha reductase inhibitor

1mg daily

Intervention Type DRUG

Other Intervention Names

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Nebido® Orgametril® Androcur® Estradot® Finasterid®

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Rupert Lanzenberger

A/Prof. PD Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rupert Lanzenberger, MD A/Prof

Role: PRINCIPAL_INVESTIGATOR

Medical University of Vienna

Locations

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Department of Psychiatry and Psychotherapy, Medical University of Vienna

Vienna, , Austria

Site Status

Countries

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Austria

References

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Kranz GS, Wadsak W, Kaufmann U, Savli M, Baldinger P, Gryglewski G, Haeusler D, Spies M, Mitterhauser M, Kasper S, Lanzenberger R. High-Dose Testosterone Treatment Increases Serotonin Transporter Binding in Transgender People. Biol Psychiatry. 2015 Oct 15;78(8):525-33. doi: 10.1016/j.biopsych.2014.09.010. Epub 2014 Sep 23.

Reference Type DERIVED
PMID: 25497691 (View on PubMed)

Other Identifiers

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AP13214ONB

Identifier Type: -

Identifier Source: org_study_id

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