Status:
COMPLETED
Testosterone and Its Metabolites in GID
Lead Sponsor:
Unita Complessa di Ostetricia e Ginecologia
Collaborating Sponsors:
Schering-Plough
Conditions:
Transsexualism
Eligibility:
FEMALE
18-45 years
Phase:
PHASE3
Brief Summary
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 re...
Detailed Description
BACKGROUND GID is a psychic disorder in which an otherwise normal person feels like he/she is a member of the opposite sex to which she/he belongs biologically. These patients require hormonal treatme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2008
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00146146
Start Date
May 1 2005
End Date
January 1 2008
Last Update
March 21 2018
Active Locations (1)
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1
Clinic of Obstetrics and Gynecology - S. Orsola Hospital
Bologna, Italy, 40138