Hypogonadism Clinical Trial
— DUTMUSCLE-20Official title:
A Randomized Double-blind Placebo-controlled Pilot Trial on the Effects of Testosterone Undecanoate Plus Dutasteride or Placebo on Muscle Strength, Body Composition and Metabolic Profile in Transmen
Verified date | September 2020 |
Source | Unita Complessa di Ostetricia e Ginecologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 16 |
Est. completion date | October 15, 2010 |
Est. primary completion date | July 30, 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Unita Complessa di Ostetricia e Ginecologia |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in isokinetic knee extension and flexion peak torque (PT-IKE and PT-IKF) | Isokinetic peak torques were determined using isokinetic dynamometry (Biodex System 4 Pro, Medical Systems, Shirley, NY) at all four time points. | At baseline and after 54 weeks of treatment | |
Primary | Change in handgrip strength | Three trials of three sets of maximal isometric handgrip on a mechanical dynamometer (model Grip-A, Takei Physical Fitness Test TKK 5001, Japan), alternately with the dominant and non-dominant hand, with a three minute rest between each trial | At baseline and after 54 weeks of treatment | |
Primary | Change in body composition | Dual-energy X-ray absorptiometry was performed using the Hologic 49159 densitometer and standard QDR body composition software (Model QDR4500W, Software Level 11.2, Hologic Spine; Hologic, Bedford, MA) for the measurement of body fat and lean mass | At baseline and after 54 weeks of treatment | |
Primary | Change in bone mineral density | Dual-energy X-ray absorptiometry was performed using the Hologic 49159 densitometer and standard QDR body composition software (Model QDR4500W, Software Level 11.2, Hologic Spine; Hologic, Bedford, MA) for the evaluation of bone mineral density at lumbar and femoral site | At baseline and after 54 weeks of treatment | |
Primary | Change in anthropometric assessment: BMI | weight, stature will be combined to report the BMI (kg/m^2) | At baseline and after 54 weeks of treatment | |
Primary | Change in anthropometric assessment: waist-to-hip ratio | Waist and hip circumferences will be combined to report the waist-to-hip ratio (WHR) | At baseline and after 54 weeks of treatment | |
Secondary | Change in psychological profile with the brief Profile of Mood State (POMS) | The POMS is a self-reporting questionnaire consisting of 30 items in six categories: tension-anxiety, depression, anger-hostility, vigor, fatigue and confusion, which are scored from 1-4 according to severity | At baseline and after 54 weeks of treatment | |
Secondary | Change in the satisfaction with their sexual life | using a Visual Analogue General Satisfaction Scale (VAS). A VAS for satisfaction is a horizontal line of 10-cm long. At the start and finish there are two descriptors representing extremes of satisfaction (i.e. no satisfaction and extreme satisfaction). Subjects respond to the question 'Are you satisfied with your sexual life now?' and rate their satisfaction by making a vertical mark on the 100-mm line. The measurement in millimeters is converted to the same number of points ranging from zero to 10 points. | At baseline and after 54 weeks of treatment | |
Secondary | Change in in the bone metabolism: osteocalcin | Evaluation of serum osteocalcin (OC) change | At baseline and after 54 weeks of treatment | |
Secondary | Change in in the bone metabolism: parathyroid hormone | Evaluation of serum parathyroid hormone (PTH) changes | At baseline and after 54 weeks of treatment | |
Secondary | Change in in the bone metabolism: bone alkaline phosphatase | Evaluation of serum bone alkaline phosphatase (BAP) changes | At baseline and after 54 weeks of treatment | |
Secondary | Change in in the bone metabolism: urinary excretion of electrolites | Changes in the 24h urinary excretion of electrolites | At baseline and after 54 weeks of treatment | |
Secondary | Change in in the insulin resistance | Change in the HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) | At baseline and after 54 weeks of treatment | |
Secondary | Change in the lipid profile | Changes in cholesterol (Tot Chol and high- and low-density lipoproteins) levels | At baseline and after 54 weeks of treatment | |
Secondary | Change in the lipid profile | Changes in triglycerides levels | At baseline and after 54 weeks of treatment |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03126656 -
Effects of Testosterone on Myocardial Repolarization
|
Phase 4 | |
Terminated |
NCT02419105 -
Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors
|
Phase 3 | |
Withdrawn |
NCT02137265 -
Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism
|
N/A | |
Completed |
NCT02233751 -
Pharmacokinetic Study of Subcutaneous Testosterone Enanthate
|
Phase 1 | |
Completed |
NCT02222558 -
Oral Testosterone for the Treatment of Hypogonadism in Males
|
Phase 2 | |
Completed |
NCT01887418 -
Pharmacokinetic Study of Testosterone Enanthate
|
Phase 1/Phase 2 | |
Terminated |
NCT01092858 -
NEBIDO in Symptomatic Late Onset Hypogonadism (SLOH)
|
Phase 4 | |
Completed |
NCT00624624 -
Follow-up of Serum Androgen Profile After Bariatric Surgery in Men With Obesity Related Hypogonadotropic Hypogonadism
|
N/A | |
Completed |
NCT00752869 -
Efficacy Study for Use of Dutasteride (Avodart) With Testosterone Replacement
|
Phase 4 | |
Completed |
NCT00613288 -
Testosterone and Lipolysis, Insulin Sensitivity and Protein Metabolism
|
N/A | |
Completed |
NCT00838838 -
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
|
N/A | |
Completed |
NCT00119483 -
Older Men and Testosterone
|
N/A | |
Completed |
NCT00004438 -
Leuprolide in Treating Adults With Hypogonadotropism
|
N/A | |
Withdrawn |
NCT00398034 -
Analgesic Efficacy of Testosterone Replacement in Hypogonadal Opioid-treated Chronic Pain Patients: A Pilot Study.
|
Phase 2 | |
Completed |
NCT02937740 -
Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™
|
Phase 4 | |
Completed |
NCT02921386 -
The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate
|
Phase 2 | |
Completed |
NCT01717768 -
Oral Testosterone for the Treatment of Hypogonadism
|
Phase 2 | |
Terminated |
NCT01460654 -
Testosterone and Alendronate in Hypogonadal Men
|
Phase 2 | |
Completed |
NCT00998933 -
Study of Serum Testosterone Levels in Non-dosed Females After Secondary Exposure
|
Phase 1 | |
Withdrawn |
NCT00710827 -
Nebido Versus Placebo in Elderly Men With Typical Symptoms of Late Onset Hypogonadism Over a Period of 54 Weeks
|
Phase 4 |