Testopel ® vs. Generic Testosterone Pellets.

July 20, 2023 updated by: Ranjith Ramasamy, MD, University of Miami

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

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.

Study Overview

Detailed 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 Type

Interventional

Enrollment (Actual)

75

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Testopel 75mg Group
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.
75 mg Testosterone pellets administered subcutaneously.
Active Comparator: Compounded testosterone pellets 100mg Group
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.
100 mg Testosterone pellets administered subcutaneously.
Active Comparator: Compounded Testosterone pellets 200mg Group
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.
200 mg Testosterone pellets administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Testosterone (T) Levels
Time Frame: Baseline, 2 months, 4 months, and 6 months
Changes in serum Testosterone levels are assessed in ng/dL
Baseline, 2 months, 4 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hematocrit (Hct) Levels.
Time Frame: Baseline, 2 months, 4 months, and 6 months
Changes in serum Hct levels are assessed in %.
Baseline, 2 months, 4 months, and 6 months
Change in PSA Levels
Time Frame: Baseline, 2 months, 4 months, and 6 months
Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.
Baseline, 2 months, 4 months, and 6 months
Change in Estradiol Levels
Time Frame: Baseline, 2 months, 4 months, and 6 months
Change in serum estradiol levels are assessed in pg/mL.
Baseline, 2 months, 4 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Ranjith Ramasamy, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 12, 2020

Primary Completion (Actual)

December 20, 2022

Study Completion (Actual)

December 20, 2022

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 19, 2020

First Posted (Actual)

August 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 14, 2023

Last Update Submitted That Met QC Criteria

July 20, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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