Effects of Testosterone Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolism in Transmen

• Status: Completed
• Trial end date: 2010-10-15
• Target enrollment: 0
• Participant gender: Female

Summary

To compare the effects on body composition and muscle strengthof 54-weeks treatment with of testosterone undecanoate combined with placebo or with the 5a-reductase inhibitor dutasteride

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

Details

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

Criteria

Inclusion Criteria:

• Healthy transmen

• Previous bilateral gonadectomy during sex reassigning surgery

• 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

• No concomitant use of drugs known to affect the hypothalamic-pituitary-ovarian axis

• Written Consent Form

• High probability of a good compliance and termination of the study

Exclusion Criteria:

• 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

• Subjects reporting desire to perform regular physical exercises for the duration of the study

• 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

• Arterial hypertension

• Diabetes mellitus

• Acute or chronic hepatic diseases

• Manifest renal diseases with renal dysfunction

• Severe internal diseases

• 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