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Hormone Therapy

Testopel 75mg Group for Low Testosterone

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

Study Summary

This trial is testing different testosterone treatments in men with low testosterone levels to see how it affects their vascular health.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 2 months, 4 months, and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 months, 4 months, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Testosterone (T) Levels
Secondary outcome measures
Change in Estradiol Levels
Change in Hematocrit (Hct) Levels.
Change in PSA Levels

Side effects data

From 2022 Phase 3 trial • 75 Patients • NCT04523480
3%
Pellet Extrusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Testopel 75mg Group
Compounded Testosterone Pellets 100mg Group
Compounded Testosterone Pellets 200mg Group

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
900 Previous Clinical Trials
409,857 Total Patients Enrolled
Empower Research IncIndustry Sponsor
1 Previous Clinical Trials
102 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are being signed up for this research project?

"As of right now, this clinical trial is not admitting any more patients. It was first posted on March 12th, 2020 and was updated on October 17th, 2022. For those looking for other trials, there are 37 trials for hypogonadism and 33 trials for Testopel that are still admitting patients."

Answered by AI

Is Testopel a common medication used in research?

"At present, there are 33 active clinical trials for Testopel. Of these, 5 are in Phase 3. The majority of Testopel trials are being conducted in Houston, Texas; however, there are158 total locations running studies for this medication."

Answered by AI

To whom does this research project extend an invitation?

"Researchers conducting this study are in need of 120 individuals that have hypogonadism and are between the ages of 18 and 75. Furthermore, it is crucial that potential participants meet the following requirements: They must be able to sign the study's consent form(s), which have been approved by an Institutional Review Board (IRB). Prior to the beginning of any procedures, written consent must be given. The individual must also be male, naïve to androgen replacement or have completed a washout period of 4 weeks after androgen treatment."

Answered by AI

Are there any negative health effects associated with Testopel?

"There is already some data to support Testopel's efficacy, as well as numerous data sets providing evidence of its safety. Therefore, we have rated Testopel as a 3 on our Power scale."

Answered by AI

What indications is Testopel usually prescribed for?

"Testopel is frequently used to manage hypothalamo-pituitary disorders. Additionally, it has been found to be an effective intervention for managing other conditions such as delayed puberty, breast cancer, and asthma."

Answered by AI

Does this experiment only allow people who are 20 years or older to participate?

"The age bracket for people that can qualify for this clinical trial is 18 to 75. However, there are 3 separate clinical trials for minors and 45 different trials for elderly patients."

Answered by AI

Are we still able to include new test subjects in this experiment?

"At this time, this study is not looking for any new candidates. According to the study's post on clinicaltrials.gov, the last update was on October 17th, 2020. If you are looking for other studies, 37 trials for hypogonadism and 33 for Testopel are currently underway."

Answered by AI

Who else is applying?

What state do they live in?
New York
Texas
Florida
How old are they?
65+
18 - 65
What site did they apply to?
University of Miami, Department of Urology
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
~15 spots leftby Apr 2025