Testosterone and Its Metabolites in GID - Full Text View

Sponsor:	Unita Complessa di Ostetricia e Ginecologia
Collaborator:	Schering-Plough
Information provided by:	Unita Complessa di Ostetricia e Ginecologia
ClinicalTrials.gov Identifier:	NCT00146146

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study
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:

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Letrozole Dutasteride Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

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:

1000 mg/12 weeks

TU 1000 mg/12 weeks Letrozole 2.5 mg/day

TU 1000 mg/12weeks Dutasteride 0.5 mg/day

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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

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:

Cherrier MM, Matsumoto AM, Amory JK, Ahmed S, Bremner W, Peskind ER, Raskind MA, Johnson M, Craft S. The role of aromatization in testosterone supplementation: effects on cognition in older men. Neurology. 2005 Jan 25;64(2):290-6.

Reddy DS. Testosterone modulation of seizure susceptibility is mediated by neurosteroids 3alpha-androstanediol and 17beta-estradiol. Neuroscience. 2004;129(1):195-207.

Swaab DF. Sexual differentiation of the human brain: relevance for gender identity, transsexualism and sexual orientation. Gynecol Endocrinol. 2004 Dec;19(6):301-12. Review.

Turner A, Chen TC, Barber TW, Malabanan AO, Holick MF, Tangpricha V. Testosterone increases bone mineral density in female-to-male transsexuals: a case series of 15 subjects. Clin Endocrinol (Oxf). 2004 Nov;61(5):560-6.

Cherrier MM, Anawalt BD, Herbst KL, Amory JK, Craft S, Matsumoto AM, Bremner WJ. Cognitive effects of short-term manipulation of serum sex steroids in healthy young men. J Clin Endocrinol Metab. 2002 Jul;87(7):3090-6.

Bagatell CJ, Heiman JR, Rivier JE, Bremner WJ. Effects of endogenous testosterone and estradiol on sexual behavior in normal young men. J Clin Endocrinol Metab. 1994 Mar;78(3):711-6. Erratum in: J Clin Endocrinol Metab 1994 Jun;78(6):1520.

Amory JK, Watts NB, Easley KA, Sutton PR, Anawalt BD, Matsumoto AM, Bremner WJ, Tenover JL. Exogenous testosterone or testosterone with finasteride increases bone mineral density in older men with low serum testosterone. J Clin Endocrinol Metab. 2004 Feb;89(2):503-10.

Levy A, Crown A, Reid R. Endocrine intervention for transsexuals. Clin Endocrinol (Oxf). 2003 Oct;59(4):409-18. Review. No abstract available.

Tangpricha V, Ducharme SH, Barber TW, Chipkin SR. Endocrinologic treatment of gender identity disorders. Endocr Pract. 2003 Jan-Feb;9(1):12-21. Review.

Moore E, Wisniewski A, Dobs A. Endocrine treatment of transsexual people: a review of treatment regimens, outcomes, and adverse effects. J Clin Endocrinol Metab. 2003 Aug;88(8):3467-73. Review.

Responsible Party:	Unita Complessa di Ostetricia e Ginecologia ( Dr Meriggiola Maria Cristina )
Study ID Numbers:	GID/2004
Study First Received:	September 1, 2005
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00146146 History of Changes
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
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Letrozole
Methyltestosterone
Sexual and Gender Disorders
Hormones

Pharmacologic Actions
Testosterone 17 beta-cypionate
Dutasteride
Anabolic Agents
Testosterone
Mental Disorders
Therapeutic Uses
Transsexualism
Aromatase Inhibitors
Androgens

ClinicalTrials.gov processed this record on February 08, 2010