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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00435513
Other study ID # 000001
Secondary ID
Status Completed
Phase Phase 0
First received February 14, 2007
Last updated May 3, 2015
Start date March 2007
Est. completion date July 2008

Study information

Verified date May 2015
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority Austria: Agency for Health and Food Safety
Study type Observational

Clinical Trial Summary

Genetic variations, i.e. polymorphisms, may be associated with gender dysphoria, e.g. transsexualism. This study aims to identify such variations.


Description:

Context: Early developmental exposure of the brain to sex steroids may play a role in the etiology of transsexualism.

Objective: To assess the association between transsexualism and allele and genotype frequencies of the steroid 5-alpha reductase (SRD5A2) Val89Leu polymorphism.

Design and Patients: We performed a case-control study of 100 male-to-female (MtF) transsexuals, 47 female-to-male (FtM) transsexuals, 755 male controls, and 915 female controls. DNA was extracted from buccal swabs and genotypes were determined by polymerase chain reaction.

Results: SRD5A2 Val89Leu allele frequencies (SRD5A2 V: 137/200 [69%] and SRD5A2 L: 63/200 [31%] vs. SRD5A2 V: 1065/1510 [71%] and SRD5A2 L: 445/1510 [29%], respectively; p=0.6; Odds Ratio [OR] 1.10; 95% Confidence Interval [CI] 0.76-1.58) and genotype distributions (SRD5A2 V/V+V/L: 92/100 [92%] and L/L 8/100 [8%] vs. SRD5A2 V/V+V/L: 683/755 [91%] and L/L 72/755 [9%], respectively, p=0.7; OR 0.82; 95% CI 0.24-2.84) were not significantly different between MtF transsexuals and male controls. SRD5A2 Val89Leu allele frequencies (SRD5A2 V: 70/94 [74%] and SRD5A2 L: 24/94 [26%] vs. SRD5A2 V: 1253/1830 [69%] and SRD5A2 L: 573/1830 [31%], respectively; p=0.3; OR 0.75; 95% CI 0.45-1.26) and genotype distributions (SRD5A2 V/V+V/L: 44/47 [93%] and L/L 3/47 [7%] vs. SRD5A2 V/V+V/L: 823/915 [90%] and L/L 92/915 [10%], respectively, p=0.6; OR 0.61; 95% CI 0.11-3.32) were also not significantly different between FtM transsexuals and female controls. Of note, there was no gender-specific genotype distribution among controls.

Conclusions: The SRD5A2 Val89Leu polymorphism is not associated with transsexualism and is no candidate gene of this condition.


Recruitment information / eligibility

Status Completed
Enrollment 1770
Est. completion date July 2008
Est. primary completion date May 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- transsexual individuals as defined by DSM IV criteria

Exclusion Criteria:

- unwillingness to participate

Study Design

Observational Model: Case Control, Time Perspective: Retrospective


Related Conditions & MeSH terms


Locations

Country Name City State
Austria University of Vienna, Vienna, Austria Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

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