Hypogonadism Clinical Trial
Official title:
A Pilot Study of 7 Tesla MRI Neuroimaging in Testicular Cancer Patients With Hypogonadism and Androgen Replacement Therapy
This study evaluates 7 Tesla (T) magnetic resonance imaging (MRI) in observing changes in the brain (neuroimaging) in testicular cancer patients who have decreased testosterone (hypogonadism) and are on testosterone (androgen) replacement therapy. Symptoms of hypogonadism can include fatigue, weakness, loss of libido, depression, poor concentration and erectile dysfunction. Some patients experience mental changes after diagnosis and treatment. There is some evidence that hypogonadism produces structural changes in the brain. The 7T MRI uses radio waves and a very powerful magnet linked to a computer to create detailed pictures of areas inside the body. This study may help researchers learn if 7T MRI can produce better images to assess the changes in the brain structure of testicular patients with hypogonadism and on androgen replacement therapy (ART).
PRIMARY OBJECTIVE: I. To assess longitudinal structural changes in brain architecture using MRI in hypogonadal men with testis cancer being treated with androgen replacement therapy. OUTLINE: This is an observational study. Patients undergo 7T MRI over 1-2 hours at baseline and at 12 months after baseline. Patients also undergo a proctored cognitive assessment over approximately 1 hour prior to each MRI. Additionally, patients undergo blood sample collection at screening and at 12 months after baseline MRI. ;
| 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| Withdrawn |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 |
NCT00119483 -
Older Men and Testosterone
|
N/A | |
| Completed |
NCT00838838 -
Efficacy of Nebido on Bone Mineral Density (BMD) in Hypogonadal Paraplegic Patients With Confirmed Osteoporosis
|
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 | |
| Terminated |
NCT00743327 -
Androgen Deprivation Therapy Study
|
N/A |