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Sponsors and Collaborators: |
Unita Complessa di Ostetricia e Ginecologia Schering AG "provider of testosterone undecanoate" |
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Information provided by: | Unita Complessa di Ostetricia e Ginecologia |
ClinicalTrials.gov Identifier: | NCT00146146 |
The purposes of this study are:
Condition | Intervention | Phase |
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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) |
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) |
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Healthy biological females, between 18 and 45 years of age:
Exclusion Criteria:
Subjects cannot be enrolled in this study if one or more of the following criteria apply:
Italy | |
Clinic of Obstetrics and Gynecology - S. Orsola Hospital | |
Bologna, Italy, 40138 |
Principal Investigator: | Cristina M Meriggiola, MD | University of Bologna |
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 |
transsexualism testosterone dihydrotestosterone estradiol |
Sexual Dysfunctions, Psychological Antineoplastic Agents, Hormonal Hormone Antagonists Estradiol valerate Hormones, Hormone Substitutes, and Hormone Antagonists Letrozole Methyltestosterone Estradiol 17 beta-cypionate Hormones Estradiol Testosterone 17 beta-cypionate |
Dutasteride Anabolic Agents Testosterone Mental Disorders Estradiol 3-benzoate Dihydrotestosterone Transsexualism Aromatase Inhibitors Polyestradiol phosphate Androgens |
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 |