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Sex Steroids and the Serotonin Transporter

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Medical University of Vienna

Status and phase

Completed
Phase 4

Conditions

Transsexualism

Treatments

Drug: Testolactone undecanoate
Drug: Lynestrenol
Drug: Cyproterone Acetate
Drug: Estradiol
Drug: 5-alpha reductase inhibitor

Study type

Interventional

Funder types

Other

Identifiers

NCT01065220
AP13214ONB

Details and patient eligibility

About

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.

Enrollment

32 patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

32 participants in 2 patient groups

hormone treatment for MtF
Experimental group
Description:
* cyproterone acetate * estradiol * alpha-5-reductase-inhibitor
Treatment:
Drug: 5-alpha reductase inhibitor
Drug: Estradiol
Drug: Cyproterone Acetate
hormone treatment for FtM
Experimental group
Description:
* testosterone undecanoate * lynestrenol
Treatment:
Drug: Lynestrenol
Drug: Testolactone undecanoate

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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