CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 15 enrolled
Drug / intervention
testosterone undecanoate alone +2 moredrug
Likely dose
testosterone undecanoate alone 1000 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00146146
NCT00146146Phase 3Completed
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Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals)

Unita Complessa di Ostetricia e Ginecologia·interventional·Posted Sep 5, 2005·Updated Mar 21, 2018

In Brief

A Phase 3 clinical trial evaluating testosterone undecanoate alone, testosterone undecanoate plus letrozole, and 1 other intervention for Transsexualism. Completed, enrolled 15 participants across 1 site.

Detailed Summary

The purposes of this study are: * to determine the role of testosterone versus dihydrotestosterone with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile * to determine the role of testosterone and dihydrotestosterone versus estradiol with respect to the following physiological functions: bone metabolism, body composition, insulin resistance and lipid profile

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTranssexualism
CountriesItaly
CollaboratorsSchering-Plough

Timeline

Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartMay 1, 2005
Primary CompletionMay 1, 2006
Study CompletionJan 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 20.8 years ago

Interventions

testosterone undecanoate alonedrug

1000 mg/12 weeks

testosterone undecanoate plus letrozoledrug

TU 1000 mg/12 weeks Letrozole 2.5 mg/day

testosterone undecanoate plus dutasteridedrug

TU 1000 mg/12weeks Dutasteride 0.5 mg/day