Phase 3
N=75
Testopel ® vs. Generic Testosterone Pellets.
Hypogonadism
Bottom Line
View on ClinicalTrials.gov: NCT04523480 ↗Enrolled (actual)
75
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Change in Testosterone (T) Levels — 219.5; 202.3; 543; 696.5 ng/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Testopel 75mg Drug Implant (Drug); Testopel 100mg Drug Implant (Drug); Testopel 200mg Drug Implant (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Miami
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Testosterone (T) Levels |
219.5; 202.3; 543; 696.5; 290; 277 | — |
| SECONDARY Change in Hematocrit (Hct) Levels. |
43.7; 42.8; 46.1; 46.7; 45.9; 45.8 | — |
| SECONDARY Change in PSA Levels |
0.9; 0.4; 1.1; 0.75; 1; 0.65 | — |
| SECONDARY Change in Estradiol Levels |
18.2; 20.6; 29.1; 42.7; 13.7; 18.4 | — |
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.
Eligibility Criteria
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 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 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04523480). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.