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Hormone Therapy
Testopel ® vs. Generic Testosterone Pellets.
Phase 3
Waitlist Available
Led By Ranjith Ramasamy, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 2 months, 4 months, and 6 months
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial is testing different testosterone treatments in men with low testosterone levels to see how it affects their vascular health.
Eligible Conditions
- Hypogonadotropic Hypogonadism
- Low Testosterone
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 2 months, 4 months, and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months, 4 months, and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in Testosterone (T) Levels
Secondary study objectives
Change in Estradiol Levels
Change in Hematocrit (Hct) Levels.
Change in PSA Levels
Side effects data
From 2022 Phase 3 trial • 75 Patients • NCT045234803%
Pellet Extrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Testopel 75mg Group
Compounded Testosterone Pellets 100mg Group
Compounded Testosterone Pellets 200mg Group
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Testopel 75mg GroupExperimental Treatment1 Intervention
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.
Group II: Compounded testosterone pellets 100mg GroupActive Control1 Intervention
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.
Group III: Compounded Testosterone pellets 200mg GroupActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Testopel 75mg Drug Implant
2020
Completed Phase 3
~80
Find a Location
Who is running the clinical trial?
Empower PharmacyUNKNOWN
University of MiamiLead Sponsor
955 Previous Clinical Trials
428,778 Total Patients Enrolled
Empower Research IncIndustry Sponsor
2 Previous Clinical Trials
134 Total Patients Enrolled
Ranjith Ramasamy, MDPrincipal Investigator - University of Miami
Univ of Miami Hosp & Clinics-Sylvester Comp Cancer Center, University of Miami Hospital
12 Previous Clinical Trials
709 Total Patients Enrolled