Testopel ® vs. Generic Testosterone Pellets.

NCT04523480 | Completed Phase 3 Results FDA Drug

• 2 other identifiers: IRBSITE0000055520192539
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypogonadism

Keywords

Low T; Low Testosterone

Outcome Measures

Primary Outcomes (1)

• Change in Testosterone (T) Levels

  Changes in serum Testosterone levels are assessed in ng/dL

  Baseline, 2 months, 4 months, and 6 months

Secondary Outcomes (3)

• Change in Hematocrit (Hct) Levels.

  Baseline, 2 months, 4 months, and 6 months

• Change in PSA Levels

  Baseline, 2 months, 4 months, and 6 months

• Change in Estradiol Levels

  Baseline, 2 months, 4 months, and 6 months

Study Arms (3)

Testopel 75mg Group

EXPERIMENTAL

Participants in this group will receive a one-time subcutaneous testosterone insertion of 10 x 75 mg pellets of Testopel for a total of 750 mg Testopel.

Drug: Testopel 75mg Drug Implant

Compounded testosterone pellets 100mg Group

ACTIVE COMPARATOR

Participants in this group will receive a one-time subcutaneous testosterone insertion of 8 x 100 mg compounded testosterone for a total of 800 mg compounded testosterone.

Drug: Testopel 100mg Drug Implant

Compounded Testosterone pellets 200mg Group

ACTIVE COMPARATOR

Participants in this group will receive a one-time subcutaneous testosterone insertion of 4 x 200 mg compounded testosterone for a total of 800 mg compounded testosterone.

Drug: Testopel 200mg Drug Implant

Interventions

Testopel 75mg Drug Implant DRUG

75 mg Testosterone pellets administered subcutaneously.

Testopel 75mg Group

Testopel 100mg Drug Implant DRUG

100 mg Testosterone pellets administered subcutaneously.

Compounded testosterone pellets 100mg Group

Testopel 200mg Drug Implant DRUG

200 mg Testosterone pellets administered subcutaneously.

Compounded Testosterone pellets 200mg Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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:
• Baseline hemoglobin \> 16 g/dL
• Hematocrit \< 35% or \> 50%
• 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.

Sponsors & Collaborators

• University of Miami: lead
• Empower Research Inc: collaborator

Study Sites (1)

University of Miami, Department of Urology

Miami, Florida, 33136, United States

Location

Related Publications (10)

• 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.

  PMID: 24054931 BACKGROUND

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

  PMID: 22319659 BACKGROUND

• 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.

  PMID: 8954042 BACKGROUND

• 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-.

  PMID: 3544993 BACKGROUND

• 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.

  PMID: 9233903 BACKGROUND

• 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.

  PMID: 7514512 BACKGROUND

• 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.

  PMID: 447801 BACKGROUND

• 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.

  PMID: 10946864 BACKGROUND

• 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.

  PMID: 23939517 BACKGROUND

• 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.

  PMID: 24470750 BACKGROUND

MeSH Terms

Conditions

Hypogonadism

Interventions

Testosterone; Drug Implants

Condition Hierarchy (Ancestors)

Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Androstenols; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Testosterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Ranjith Ramasamy, MD
• Organization: University of Miami, Miller School of Medicine - Desai Sethi Urology Institute

ramasamy@miami.edu

3052434562

Study Officials

• Ranjith Ramasamy, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Male Fertility and Andrology, University of Miami

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: August 21, 2020
• Study Start: March 12, 2020
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 14, 2023
• Results First Posted: August 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)