Transsexualism Clinical Trial
Official title:
Role of Testosterone and Its Metabolites Regarding Different Physiological Functions in Subjects Affected by Gender Identity Disorder (FtM Transsexuals)
Verified date | February 2009 |
Source | Unita Complessa di Ostetricia e Ginecologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 15 |
Est. completion date | January 2008 |
Est. primary completion date | May 2006 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Clinic of Obstetrics and Gynecology - S. Orsola Hospital | Bologna |
Lead Sponsor | Collaborator |
---|---|
Unita Complessa di Ostetricia e Ginecologia | Schering-Plough |
Italy,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Levy A, Crown A, Reid R. Endocrine intervention for transsexuals. Clin Endocrinol (Oxf). 2003 Oct;59(4):409-18. Review. — View Citation
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. — View Citation
Reddy DS. Testosterone modulation of seizure susceptibility is mediated by neurosteroids 3alpha-androstanediol and 17beta-estradiol. Neuroscience. 2004;129(1):195-207. — View Citation
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. — View Citation
Tangpricha V, Ducharme SH, Barber TW, Chipkin SR. Endocrinologic treatment of gender identity disorders. Endocr Pract. 2003 Jan-Feb;9(1):12-21. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bone metabolism | baseline and end of the study | ||
Primary | insulin resistance | baseline and end of the study | ||
Primary | lipid profile | baseline and end of the study | ||
Secondary | sexual function | baseline and end of the study | ||
Secondary | mood | baseline and end of the study | ||
Secondary | pain | baseline and end of the study |
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