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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, 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) |
Estimated Enrollment: | 15 |
Study Start Date: | May 2005 |
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:
Contact: antonietta costantino, PhD | *39 051 6363716 | enzacostantino@libero.it |
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 |
Principal Investigator: | Cristina M Meriggiola, MD | University of Bologna |
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 |
transsexualism testosterone dihydrotestosterone estradiol |
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 |
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 |