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Testosterone and Its Metabolites in GID
This study is currently recruiting participants.
Verified by Unita Complessa di Ostetricia e Ginecologia, September 2005
Sponsors and Collaborators: Unita Complessa di Ostetricia e Ginecologia
Schering AG "provider of testosterone undecanoate"
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

Drug Information available for: Testosterone Methyltestosterone Oxymesterone Testosterone enanthate Testosterone Propionate Testosterone undecanoate Depogen Estradiol Estradiol 3-benzoate Estradiol acetate Estradiol cypionate Estradiol dipropionate Estradiol valerate Polyestradiol phosphate Dutasteride Letrozole Stanolone
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, 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)

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

Primary Outcome Measures:
  • - bone metabolism
  • body composition
  • insulin resistance
  • lipid profile

Secondary Outcome Measures:
  • sexual function
  • mood
  • pain

Estimated Enrollment: 15
Study Start Date: May 2005
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00146146

Contacts
Contact: antonietta costantino, PhD *39 051 6363716 enzacostantino@libero.it

Locations
Italy
Clinic of Obstetrics and Gynecology - S. Orsola Hospital Recruiting
Bologna, Italy, 40138
Contact: Cristina M Meriggiola, MD     *39 051 6363716     cristina.meriggiola@unibo.it    
Contact: Antonietta Costantino, PhD     *39 051 6363716     enzacostantino@libero.it    
Principal Investigator: Cristina M Meriggiola, MD            
Sponsors and Collaborators
Unita Complessa di Ostetricia e Ginecologia
Schering AG "provider of testosterone undecanoate"
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.

Study ID Numbers: GID/2004
Study First Received: September 1, 2005
Last Updated: September 7, 2006
ClinicalTrials.gov Identifier: NCT00146146  
Health Authority: Italy: National Institute of Health

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

Study placed in the following topic categories:
Sexual Dysfunctions, Psychological
Estradiol valerate
Letrozole
Methyltestosterone
Estradiol 17 beta-cypionate
Estradiol
Testosterone 17 beta-cypionate
Dutasteride
Testosterone
Mental Disorders
Estradiol 3-benzoate
Dihydrotestosterone
Transsexualism
Polyestradiol phosphate

Additional relevant MeSH terms:
Anabolic Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Hormones
Sexual and Gender Disorders
Pharmacologic Actions
Androgens

ClinicalTrials.gov processed this record on January 16, 2009