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Testopel ® vs. Generic Testosterone Pellets.

NCT04523480 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2023-08-14

Study results available
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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

Interventions

DRUG

Testopel 75mg Drug Implant

75 mg Testosterone pellets administered subcutaneously.

DRUG

Testopel 100mg Drug Implant

100 mg Testosterone pellets administered subcutaneously.

DRUG

Testopel 200mg Drug Implant

200 mg Testosterone pellets administered subcutaneously.

Sponsors & Collaborators

  • Empower Research Inc

    collaborator INDUSTRY

  • University of Miami

    lead OTHER

Principal Investigators

  • Ranjith Ramasamy, MD · University of Miami

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-12
Primary Completion
2022-12-20
Completion
2022-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04523480 on ClinicalTrials.gov