Trial Outcomes & Findings for A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections (NCT NCT04439799)
NCT ID: NCT04439799
Last Updated: 2023-12-13
Results Overview
Changes in serum Hematocrit levels will be assessed in percentage
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
Baseline to 4 months
Results posted on
2023-12-13
Participant Flow
Participant milestones
| Measure |
Testosterone Cypionate Group
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
40
|
|
Overall Study
COMPLETED
|
31
|
23
|
|
Overall Study
NOT COMPLETED
|
10
|
17
|
Reasons for withdrawal
| Measure |
Testosterone Cypionate Group
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
6
|
|
Overall Study
Withdrawal by Subject
|
2
|
6
|
|
Overall Study
Adverse Event
|
2
|
5
|
Baseline Characteristics
A Comparison of Side Effects in Hypogonadal Men Treated With Natesto Versus Testosterone Injections
Baseline characteristics by cohort
| Measure |
Testosterone Cypionate Group
n=41 Participants
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
n=40 Participants
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.46 years
STANDARD_DEVIATION 11.86 • n=5 Participants
|
48.2 years
STANDARD_DEVIATION 10.89 • n=7 Participants
|
48.33 years
STANDARD_DEVIATION 11.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
29 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 4 monthsChanges in serum Hematocrit levels will be assessed in percentage
Outcome measures
| Measure |
Testosterone Cypionate Group
n=31 Participants
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
n=23 Participants
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Change in Hematocrit (Hct) Levels.
|
3.0 percentage of hematocrit
Interval 2.8 to 5.0
|
-0.6 percentage of hematocrit
Interval -1.5 to 0.4
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsPopulation: In the Natesto group, three participants group did not have Testosterone labs collected and four did not have 17-OHP laboratory tests collected due to protocol non-compliance. in the Testosterone Cypionate group, Nine group did not have 17-OHP labs collected due to protocol non-compliance.
Change in serum hormone levels including Testosterone, 17-Hydroxyprogesterone (17-OHP) assessed in ng/dL.
Outcome measures
| Measure |
Testosterone Cypionate Group
n=31 Participants
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
n=20 Participants
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Change in Hormone Levels
Testosterone
|
511 ng/dL
Interval 373.0 to 650.0
|
283 ng/dL
Interval 149.0 to 417.0
|
|
Change in Hormone Levels
17-OHP
|
-39.8 ng/dL
Interval -53.1 to -26.5
|
-8.8 ng/dL
Interval -24.4 to 6.7
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsPopulation: Six participants in the Testosterone Cypionate group did not have PSA laboratory tests performed due to protocol non-compliance. Six participants in the Natesto group did not have PSA laboratory tests performed due to protocol non-compliance.
Change in serum Prostate Specific Antigen (PSA) levels will be assessed in ng/mL.
Outcome measures
| Measure |
Testosterone Cypionate Group
n=25 Participants
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
n=17 Participants
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Change in PSA Levels
|
0.6 ng/mL
Interval -0.02 to 1.23
|
0.05 ng/mL
Interval -0.22 to 0.32
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsPopulation: In the Testosterone Cypionate group, seven participants did not have estradiol laboratory tests performed due to protocol non-compliance. in the Natesto group three participants did not have estradiol laboratory tests performed due to protocol non-compliance.
Change in serum estradiol levels will be assessed in pg/mL.
Outcome measures
| Measure |
Testosterone Cypionate Group
n=24 Participants
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
n=20 Participants
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Change in Estradiol Levels
|
22.9 pg/mL
Interval 11.0 to 34.8
|
1.1 pg/mL
Interval -5.7 to 7.8
|
SECONDARY outcome
Timeframe: Baseline to 4 monthsPopulation: In the Testosterone Cypionate group, fourteen participants did not complete the IIEF-6 questionnaire due to protocol non-compliance. In the Natesto group thirteen participants did not complete the IIEF-6 questionnaire due to protocol non-compliance.
The International Index of Erectile Function (IIEF)-6 is a 6-item subdomain self-evaluation questionnaire of erectile function. Each item is scored from 0-5 with the total score ranging from 0-30 with the higher score indicating better erectile function.
Outcome measures
| Measure |
Testosterone Cypionate Group
n=17 Participants
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
n=10 Participants
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Changes in IIEF-6 Score
|
4.8 score on a scale
Interval 1.1 to 8.5
|
0.2 score on a scale
Interval -3.6 to 4.0
|
Adverse Events
Testosterone Cypionate Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Natesto Group
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Testosterone Cypionate Group
n=41 participants at risk
Participants in this group will receive the intramuscular Testosterone Cypionate intervention for four months
Testosterone Cypionate 200 Mg/ML: Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
|
Natesto Group
n=40 participants at risk
Participants in this group will receive the intranasal testosterone (Natesto) intervention for four months.
Intranasal Testosterone: Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as three daily doses (5.5 mg per nostril, 11.0 mg single dose) for four consecutive months,
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/41 • 4 months
|
7.5%
3/40 • Number of events 3 • 4 months
|
|
Ear and labyrinth disorders
Labyrithitis
|
0.00%
0/41 • 4 months
|
2.5%
1/40 • Number of events 1 • 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/41 • 4 months
|
2.5%
1/40 • Number of events 1 • 4 months
|
|
General disorders
Generalized Edema
|
2.4%
1/41 • Number of events 1 • 4 months
|
0.00%
0/40 • 4 months
|
|
Blood and lymphatic system disorders
Anemia
|
2.4%
1/41 • Number of events 1 • 4 months
|
0.00%
0/40 • 4 months
|
Additional Information
Ranjith Ramasamy, MD
University of Miami, Miller School of Medicine - Desai Sethi Urology Institute
Phone: 305-243-6596
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place