Testosterone and Its Metabolites in GID

This study has been completed.
Sponsor:
Collaborator:
Schering-Plough
Information provided by:
Unita Complessa di Ostetricia e Ginecologia
ClinicalTrials.gov Identifier:
NCT00146146
First received: September 1, 2005
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

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

Condition Intervention Phase
Transsexualism
Drug: testosterone undecanoate alone
Drug: testosterone undecanoate plus letrozole
Drug: testosterone undecanoate plus dutasteride
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals)

Resource links provided by NLM:


Further study details as provided by Unita Complessa di Ostetricia e Ginecologia:

Primary Outcome Measures:
  • bone metabolism [ Time Frame: baseline and end of the study ] [ Designated as safety issue: Yes ]
  • insulin resistance [ Time Frame: baseline and end of the study ] [ Designated as safety issue: Yes ]
  • lipid profile [ Time Frame: baseline and end of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • sexual function [ Time Frame: baseline and end of the study ] [ Designated as safety issue: Yes ]
  • mood [ Time Frame: baseline and end of the study ] [ Designated as safety issue: Yes ]
  • pain [ Time Frame: baseline and end of the study ] [ Designated as safety issue: Yes ]

Enrollment: 15
Study Start Date: May 2005
Study Completion Date: January 2008
Primary Completion Date: May 2006 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: testosterone undecanoate alone
    1000 mg/12 weeks
    Other Name: Nebid
    Drug: testosterone undecanoate plus letrozole
    TU 1000 mg/12 weeks Letrozole 2.5 mg/day
    Other Name: Nebid
    Drug: testosterone undecanoate plus dutasteride
    TU 1000 mg/12weeks Dutasteride 0.5 mg/day
    Other Names:
    • Nebid
    • Avodart
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Healthy biological females, between 18 and 45 years of age:

  • SR surgery performed
  • Body Mass Index (BMI) between 20 and 29 kg/m²; (body weight in kilograms divided by body height in meters squared)
  • Clinical examination without pathological findings relevant to the study
  • Clinico-chemical laboratory values do not suggest an illness
  • Written Consent Form has been signed
  • High probability of a good compliance and termination of the study

Exclusion Criteria:

Subjects cannot be enrolled in this study if one or more of the following criteria apply:

  • Participation in another clinical trial within the 30 days preceding the first administration
  • Simultaneous participation in another clinical trial
  • Subjects institutionalized or imprisoned by order of the court
  • Subject who compete in sports which use IOC drug monitoring
  • Serious organic or psychic disease suspected from history and/or clinical examination
  • Diseases (especially tumors) that might represent an actual contraindication for testosterone
  • Past or present history of thrombotic or embolic diseases
  • Hypertension requiring therapy (BP 140/90 mmHg)
  • Diabetes mellitus requiring therapy
  • Acute or chronic hepatic diseases
  • Manifest renal diseases with renal dysfunction
  • Severe internal diseases as well as use of any medication to treat such
  • Biochemical and/or hematological laboratory values beyond normal ranges unless the Investigator confirms that the deviations are of no clinical relevance
  • Any indication of chronic use of drugs, alcohol, opiates or recreational drugs
  • Use of any drug known to affect biotransformation of testosterone and/or progestin, e.g. chlorcycline, phenobarbital, phenylbutazone, aminophenazone within the 30 days preceding the first administration of the test medication and during the study
  • Use of oral anticoagulatory drugs within the 30 days preceding the first administration of the test medication and during the study
  • Any oral or transdermal hormone medication within the 12 weeks preceding the first administration and during the study
  • Probability of poor compliance and termination of the study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00146146

Locations
Italy
Clinic of Obstetrics and Gynecology - S. Orsola Hospital
Bologna, Italy, 40138
Sponsors and Collaborators
Unita Complessa di Ostetricia e Ginecologia
Schering-Plough
Investigators
Principal Investigator: Cristina M Meriggiola, MD University of Bologna
  More Information

Publications:

Responsible Party: Dr Meriggiola Maria Cristina, Unita Complessa di Ostetricia e Ginecologia
ClinicalTrials.gov Identifier: NCT00146146     History of Changes
Other Study ID Numbers: GID/2004
Study First Received: September 1, 2005
Last Updated: February 17, 2009
Health Authority: Italy: National Institute of Health

Keywords provided by Unita Complessa di Ostetricia e Ginecologia:
transsexualism
testosterone
dihydrotestosterone
estradiol

Additional relevant MeSH terms:
Sexual Dysfunctions, Psychological
Sexual and Gender Disorders
Transsexualism
Mental Disorders
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Letrozole
Dutasteride
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
5-alpha Reductase Inhibitors
Urological Agents

ClinicalTrials.gov processed this record on September 18, 2014