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Testosterone and Its Metabolites in GID

NCT00146146 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2018-03-21

No results posted yet for this study

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

Conditions

  • Transsexualism

Interventions

DRUG

testosterone undecanoate alone

1000 mg/12 weeks

DRUG

testosterone undecanoate plus letrozole

TU 1000 mg/12 weeks Letrozole 2.5 mg/day

DRUG

testosterone undecanoate plus dutasteride

TU 1000 mg/12weeks Dutasteride 0.5 mg/day

Sponsors & Collaborators

  • Schering-Plough

    collaborator INDUSTRY

  • Unita Complessa di Ostetricia e Ginecologia

    lead OTHER

Principal Investigators

  • Cristina M Meriggiola, MD · University of Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-05-31
Completion
2008-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00146146 on ClinicalTrials.gov