Testosterone and Its Metabolites in GID

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: Female

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 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

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Unita Complessa di Ostetricia e Ginecologia
• Collaborator: Schering-Plough
• Treatments: Dutasteride; Letrozole; Methyltestosterone; Testosterone; Testosterone 17 beta-cypionate; Testosterone enanthate; Testosterone undecanoate

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