Trial Outcomes & Findings for Testopel ® vs. Generic Testosterone Pellets. (NCT NCT04523480)
NCT ID: NCT04523480
Last Updated: 2023-08-14
Results Overview
Changes in serum Testosterone levels are assessed in ng/dL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
75 participants
Primary outcome timeframe
Baseline, 2 months, 4 months, and 6 months
Results posted on
2023-08-14
Participant Flow
Participant milestones
| Measure |
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
|---|---|---|---|
|
Overall Study
STARTED
|
33
|
42
|
0
|
|
Overall Study
COMPLETED
|
3
|
7
|
0
|
|
Overall Study
NOT COMPLETED
|
30
|
35
|
0
|
Reasons for withdrawal
| Measure |
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
30
|
35
|
0
|
Baseline Characteristics
Testopel ® vs. Generic Testosterone Pellets.
Baseline characteristics by cohort
| Measure |
Testopel 75mg Group
n=33 Participants
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
Compounded Testosterone Pellets 100mg Group
n=42 Participants
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54.5 years
n=99 Participants
|
52.5 years
n=107 Participants
|
—
|
53.5 years
n=157 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
75 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
22 Participants
n=157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
9 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
13 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
53 Participants
n=157 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2 months, 4 months, and 6 monthsPopulation: Zero participants were enrolled into the "Compounded Testosterone pellets 200mg Group" due to the pharmacy being unable to produce the investigational product at that dosage amount.
Changes in serum Testosterone levels are assessed in ng/dL
Outcome measures
| Measure |
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
Testopel 75mg Group
n=33 Participants
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
Compounded Testosterone Pellets 100mg Group
n=42 Participants
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
|---|---|---|---|
|
Change in Testosterone (T) Levels
Baseline
|
—
|
219.5 ng/dL
Interval 194.0 to 252.0
|
202.3 ng/dL
Interval 143.5 to 256.0
|
|
Change in Testosterone (T) Levels
Month 2
|
—
|
543 ng/dL
Interval 460.0 to 716.5
|
696.5 ng/dL
Interval 591.0 to 822.0
|
|
Change in Testosterone (T) Levels
Month 4
|
—
|
290 ng/dL
Interval 209.0 to 439.0
|
277 ng/dL
Interval 228.0 to 378.0
|
|
Change in Testosterone (T) Levels
Month 6
|
—
|
209 ng/dL
Interval 155.0 to 267.0
|
241 ng/dL
Interval 158.0 to 287.0
|
SECONDARY outcome
Timeframe: Baseline, 2 months, 4 months, and 6 monthsPopulation: Zero participants were enrolled into the "Compounded Testosterone pellets 200mg Group" due to the pharmacy being unable to produce the investigational product at that dosage amount.
Changes in serum Hct levels are assessed in %.
Outcome measures
| Measure |
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
Testopel 75mg Group
n=33 Participants
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
Compounded Testosterone Pellets 100mg Group
n=42 Participants
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
|---|---|---|---|
|
Change in Hematocrit (Hct) Levels.
Baseline
|
—
|
43.7 hematocrit percentage
Interval 42.3 to 46.7
|
42.8 hematocrit percentage
Interval 39.3 to 45.6
|
|
Change in Hematocrit (Hct) Levels.
Month 2
|
—
|
46.1 hematocrit percentage
Interval 42.4 to 49.4
|
46.7 hematocrit percentage
Interval 42.1 to 48.4
|
|
Change in Hematocrit (Hct) Levels.
Month 4
|
—
|
45.9 hematocrit percentage
Interval 42.8 to 48.7
|
45.8 hematocrit percentage
Interval 44.4 to 46.8
|
|
Change in Hematocrit (Hct) Levels.
Month 6
|
—
|
46 hematocrit percentage
Interval 43.1 to 47.3
|
43 hematocrit percentage
Interval 40.8 to 46.7
|
SECONDARY outcome
Timeframe: Baseline, 2 months, 4 months, and 6 monthsPopulation: Zero participants were enrolled into the "Compounded Testosterone pellets 200mg Group" due to the pharmacy being unable to produce the investigational product at that dosage amount.
Change in serum Prostate Specific Antigen (PSA) levels are assessed in ng/mL.
Outcome measures
| Measure |
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
Testopel 75mg Group
n=33 Participants
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
Compounded Testosterone Pellets 100mg Group
n=42 Participants
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
|---|---|---|---|
|
Change in PSA Levels
Baseline
|
—
|
0.9 ng/mL
Interval 0.5 to 1.6
|
0.4 ng/mL
Interval 0.3 to 0.8
|
|
Change in PSA Levels
Month 2
|
—
|
1.1 ng/mL
Interval 0.6 to 1.85
|
0.75 ng/mL
Interval 0.5 to 1.2
|
|
Change in PSA Levels
Month 4
|
—
|
1 ng/mL
Interval 0.5 to 1.6
|
0.65 ng/mL
Interval 0.5 to 1.2
|
|
Change in PSA Levels
Month 6
|
—
|
0.8 ng/mL
Interval 0.6 to 1.7
|
0.5 ng/mL
Interval 0.3 to 0.6
|
SECONDARY outcome
Timeframe: Baseline, 2 months, 4 months, and 6 monthsPopulation: Zero participants were enrolled into the "Compounded Testosterone pellets 200mg Group" due to the pharmacy being unable to produce the investigational product at that dosage amount.
Change in serum estradiol levels are assessed in pg/mL.
Outcome measures
| Measure |
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
Testopel 75mg Group
n=33 Participants
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
Compounded Testosterone Pellets 100mg Group
n=42 Participants
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
|---|---|---|---|
|
Change in Estradiol Levels
Baseline
|
—
|
18.2 pg/mL
Interval 8.5 to 25.0
|
20.6 pg/mL
Interval 8.5 to 24.3
|
|
Change in Estradiol Levels
Month 2
|
—
|
29.1 pg/mL
Interval 21.3 to 35.4
|
42.7 pg/mL
Interval 42.1 to 48.4
|
|
Change in Estradiol Levels
Month 4
|
—
|
13.7 pg/mL
Interval 8.1 to 24.6
|
18.4 pg/mL
Interval 6.9 to 29.6
|
|
Change in Estradiol Levels
Month 6
|
—
|
14.3 pg/mL
Interval 0.1 to 17.6
|
18.8 pg/mL
Interval 7.0 to 22.7
|
Adverse Events
Testopel 75mg Group
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Compounded Testosterone Pellets 100mg Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Compounded Testosterone Pellets 200mg Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testopel 75mg Group
n=33 participants at risk
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.
Testopel 75mg Drug Implant: 75 mg Testosterone pellets administered subcutaneously.
|
Compounded Testosterone Pellets 100mg Group
n=42 participants at risk
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.
Testopel 100mg Drug Implant: 100 mg Testosterone pellets administered subcutaneously.
|
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.
Testopel 200mg Drug Implant: 200 mg Testosterone pellets administered subcutaneously.
|
|---|---|---|---|
|
Surgical and medical procedures
Pellet Extrusion
|
3.0%
1/33 • Number of events 1 • Adverse events were evaluated after implantation, and at each follow up visit (months 2, 4, and 6).
zero subjects were enrolled to the 200mg treatment arm.
|
0.00%
0/42 • Adverse events were evaluated after implantation, and at each follow up visit (months 2, 4, and 6).
zero subjects were enrolled to the 200mg treatment arm.
|
—
0/0 • Adverse events were evaluated after implantation, and at each follow up visit (months 2, 4, and 6).
zero subjects were enrolled to the 200mg treatment arm.
|
Additional Information
Ranjith Ramasamy, MD
University of Miami, Miller School of Medicine - Desai Sethi Urology Institute
Phone: 3052434562
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place