Testopel ® vs. Generic Testosterone Pellets.

Hypogonadism Clinical Trial

Official title:

Randomized Control Trial of Long Acting Subcutaneous Testosterone Pellets for Hypogonadism: Testopel ® vs. Generic Testosterone Pellets.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523480
• Other study ID #: IRBSITE00000555
• Secondary ID: 20192539
• Status: Completed
• Phase: Phase 3
• Start date: March 12, 2020
• Est. completion date: December 20, 2022

Study information

• Verified date: July 2023
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Voluntarily sign and date the study consent form(s), which have been approved by an Institutional Review Board (IRB). Written consent must be obtained prior to the initiation of any study procedures.

• Male between 18 and 75 years of age.

• Documented diagnosis of primary hypogonadism (congenital or acquired) or hypogonadotropic hypogonadism (congenital or acquired).

• Serum total testosterone < 300 ng/dL on 2 measurements

• Naïve to androgen replacement or has discontinued current treatment and completed a washout of 4 weeks following androgen treatment.

• Judged to be in good general health as determined by the principal investigator based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

• History of significant sensitivity or allergy to androgens, or product excipients.

• Clinically significant findings in the pre-study examinations including abnormal breast examination requiring follow-up, abnormal ECG.

• Abnormal prostate digital rectal examination (DRE) with palpable nodule(s) or International Prostate Symptom Score (I-PSS) score > 19 points.

• Body mass index (BMI) = 40 kg/m2.

• Clinically significant abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:

1. Baseline hemoglobin > 16 g/dL

2. Hematocrit < 35% or > 50%

3. prostate-specific antigen (PSA) > 4 ng/mL

• History of seizures or convulsions, including febrile, alcohol or drug withdrawal seizures.

• History of any clinically significant illness, infection, or surgical procedure within 4 weeks prior to study drug administration.

• History of stroke or myocardial infarction within the past 5 years.

• History of, or current or suspected, prostate or breast cancer.

• History of diagnosed, severe, untreated, obstructive sleep apnea.

• History of abuse of alcohol or any drug substance in the opinion of the investigator within the previous 2 years.

• Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 12 weeks prior to the start of treatment.

• Inadequate venous access for collection of serial blood samples required for pharmacokinetic profiles.

• Receipt of any investigational product within 4 weeks or within 5 half-lives prior to the start of treatment.

• Inability to understand and provide written informed consent for the study.

Related Conditions & MeSH terms

• Hypogonadism

Intervention

Drug:
• Testopel 75mg Drug Implant
75 mg Testosterone pellets administered subcutaneously.
• Testopel 100mg Drug Implant
100 mg Testosterone pellets administered subcutaneously.
• Testopel 200mg Drug Implant
200 mg Testosterone pellets administered subcutaneously.

Locations

Country	Name	City	State
United States	University of Miami, Department of Urology	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Empower Research Inc

Country where clinical trial is conducted

United States, 

References & Publications (10)

Baillargeon J, Urban RJ, Ottenbacher KJ, Pierson KS, Goodwin JS. Trends in androgen prescribing in the United States, 2001 to 2011. JAMA Intern Med. 2013 Aug 12;173(15):1465-6. doi: 10.1001/jamainternmed.2013.6895. No abstract available. Erratum In: JAMA Intern Med. 2013 Aug 12;173(15):1477. — View Citation

Behre HM, Bohmeyer J, Nieschlag E. Prostate volume in testosterone-treated and untreated hypogonadal men in comparison to age-matched normal controls. Clin Endocrinol (Oxf). 1994 Mar;40(3):341-9. doi: 10.1111/j.1365-2265.1994.tb03929.x. — View Citation

Corona G, Rastrelli G, Maggi M. Diagnosis and treatment of late-onset hypogonadism: systematic review and meta-analysis of TRT outcomes. Best Pract Res Clin Endocrinol Metab. 2013 Aug;27(4):557-79. doi: 10.1016/j.beem.2013.05.002. Epub 2013 Jul 5. — View Citation

Davidson JM, Camargo CA, Smith ER. Effects of androgen on sexual behavior in hypogonadal men. J Clin Endocrinol Metab. 1979 Jun;48(6):955-8. doi: 10.1210/jcem-48-6-955. — View Citation

Finkelstein JS, Klibanski A, Neer RM, Greenspan SL, Rosenthal DI, Crowley WF Jr. Osteoporosis in men with idiopathic hypogonadotropic hypogonadism. Ann Intern Med. 1987 Mar;106(3):354-61. doi: 10.7326/0003-4819-106-3-. — View Citation

Jockenhovel F, Vogel E, Reinhardt W, Reinwein D. Effects of various modes of androgen substitution therapy on erythropoiesis. Eur J Med Res. 1997 Jul 28;2(7):293-8. — View Citation

Katznelson L, Finkelstein JS, Schoenfeld DA, Rosenthal DI, Anderson EJ, Klibanski A. Increase in bone density and lean body mass during testosterone administration in men with acquired hypogonadism. J Clin Endocrinol Metab. 1996 Dec;81(12):4358-65. doi: 10.1210/jcem.81.12.8954042. — View Citation

Snyder PJ, Peachey H, Berlin JA, Hannoush P, Haddad G, Dlewati A, Santanna J, Loh L, Lenrow DA, Holmes JH, Kapoor SC, Atkinson LE, Strom BL. Effects of testosterone replacement in hypogonadal men. J Clin Endocrinol Metab. 2000 Aug;85(8):2670-7. doi: 10.1210/jcem.85.8.6731. — View Citation

Ullah MI, Riche DM, Koch CA. Transdermal testosterone replacement therapy in men. Drug Des Devel Ther. 2014 Jan 9;8:101-12. doi: 10.2147/DDDT.S43475. eCollection 2014. — View Citation

Walker WH. Testosterone signaling and the regulation of spermatogenesis. Spermatogenesis. 2011 Apr;1(2):116-120. doi: 10.4161/spmg.1.2.16956. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Testosterone (T) Levels	Changes in serum Testosterone levels are assessed in ng/dL	Baseline, 2 months, 4 months, and 6 months
Secondary	Change in Hematocrit (Hct) Levels.	Changes in serum Hct levels are assessed in %.	Baseline, 2 months, 4 months, and 6 months
Secondary	Change in PSA Levels	Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.	Baseline, 2 months, 4 months, and 6 months
Secondary	Change in Estradiol Levels	Change in serum estradiol levels are assessed in pg/mL.	Baseline, 2 months, 4 months, and 6 months