Testopel ® vs. Generic Testosterone Pellets.

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate changes in vascular parameters in subjects receiving Testopel 75mg (one time) versus subjects receiving Compounded Testosterone pellets 100mg (one time) versus subjects receiving Compounded Testosterone pellets 200mg (one time) to participant with clinical hypogonadism.

Clinical Trial Description

Hypogonadism, or low testosterone (Low T), is the deficiency in producing testosterone by the testes. Testosterone pellets is a long-acting formulation of Testosterone Replacement Therapy (TRT) that is delivered subcutaneously to men diagnosed with low T. Advantages to subcutaneous testosterone pellets include ease of delivery and decreased risk of the medication being transfer upon skin contact to woman or children. Long acting testosterone replacement Implantation of six to ≥10 testosterone pellets (450 to ≥750 mg) increased total testosterone into the therapeutic range at 1 month post-implantation and sustained therapeutic levels (>300) for 4-6 months. Participants will be randomly assigned to 1 of 3 study groups. In one of the groups the treatment will include implantation of Testopel ® 750mg (10 pellets with 75mg pellet) one time, in the second group, treatment will include compounded subcutaneous testosterone 800mg (8 pellets with 100mg pellet) one time and in the third group, treatment will include compounded subcutaneous testosterone 800mg (4 pellets with 200mg pellet) one time. The treatment takes approximately 30 minutes and will include: Clean and numb the insertion site with lidocaine at 1%, followed by small incision in the skin, implantation of pellets into subdermal fat layer and sealing the incision with Steri-strip. This is the current standard of care of Testopel insertion and same procedure will be followed with both compounded and commercial pellets. ;

Study Design

Related Conditions & MeSH terms

Hypogonadism

Clinical Trial Details

NCT number	NCT04523480
Study type	Interventional
Source	University of Miami
Contact
Status	Completed
Phase	Phase 3
Start date	March 12, 2020
Completion date	December 20, 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT03126656` - Effects of Testosterone on Myocardial Repolarization	Phase 4
Withdrawn	`NCT02137265` - Assessing the Efficacy of Clomiphene Citrate in Patients With Azoospermia and Hypoandrogenism	N/A
Terminated	`NCT02419105` - Effects of Transdermal Testosterone and/or Monthly Vitamin D on Fall Risk in Pre--frail Hypogonadal Seniors	Phase 3
Completed	`NCT02222558` - Oral Testosterone for the Treatment of Hypogonadism in Males	Phase 2
Completed	`NCT02233751` - Pharmacokinetic Study of Subcutaneous Testosterone Enanthate	Phase 1
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	`NCT02921386` - The Effect of Various Amounts of Fat on PK of Oral Testosterone Undecanoate	Phase 2
Completed	`NCT02937740` - Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™	Phase 4
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