Trial Outcomes & Findings for Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™ (NCT NCT02937740)
NCT ID: NCT02937740
Last Updated: 2019-08-12
Results Overview
The primary objective of this study is to measure patient satisfaction with testosterone replacement therapy before, during and after treatment with NATESTO. Patient satisfaction with treatment will be measured by TSQM (Treatment Satisfaction Questionnaire for Medication) Version 9, a 9-item validated instrument. TSQM domains include - Effectiveness, Convenience, Global Satisfaction. The score for each domain is converted into a scale out of 100. Higher values imply a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
117 participants
Primary outcome timeframe
Baseline and 3 months for BID, 4 months for TID
Results posted on
2019-08-12
Participant Flow
Participant milestones
| Measure |
Naive Patients - ARM 1
NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.
For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.
NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.
For three times daily (after Visit 4 \[Day 90\] if symptoms not adequately managed by a BID
|
Non-naive Patients - ARM 2
NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.
For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.
NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.
For three times daily (after Visit 4 \[Day 90\] if symptoms not adequately managed by a BID dose), NATE
|
|---|---|---|
|
BID for 90 Days, 22 mg/Day
STARTED
|
24
|
93
|
|
BID for 90 Days, 22 mg/Day
COMPLETED
|
19
|
62
|
|
BID for 90 Days, 22 mg/Day
NOT COMPLETED
|
5
|
31
|
|
Uptitrated to TID on Day 90 for 30 Days
STARTED
|
13
|
17
|
|
Uptitrated to TID on Day 90 for 30 Days
COMPLETED
|
12
|
15
|
|
Uptitrated to TID on Day 90 for 30 Days
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Naive Patients - ARM 1
NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.
For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.
NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.
For three times daily (after Visit 4 \[Day 90\] if symptoms not adequately managed by a BID
|
Non-naive Patients - ARM 2
NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 122.5mg of NATESTO (5.5mg testosterone) per actuation.
For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.
NATESTO Testosterone Nasal Gel: Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.
For three times daily (after Visit 4 \[Day 90\] if symptoms not adequately managed by a BID dose), NATE
|
|---|---|---|
|
BID for 90 Days, 22 mg/Day
Withdrawal by Subject
|
3
|
14
|
|
BID for 90 Days, 22 mg/Day
Adverse Event
|
0
|
10
|
|
BID for 90 Days, 22 mg/Day
Lost to Follow-up
|
2
|
7
|
|
Uptitrated to TID on Day 90 for 30 Days
Withdrawal by Subject
|
1
|
0
|
|
Uptitrated to TID on Day 90 for 30 Days
Lost to Follow-up
|
0
|
1
|
|
Uptitrated to TID on Day 90 for 30 Days
Missed visits
|
0
|
1
|
Baseline Characteristics
Open-Label Study, Evaluating Patient Satisfaction and Symptom Improvement When Treating Male Hypogonadism With Natesto™
Baseline characteristics by cohort
| Measure |
Naive Patients - ARM 1
n=23 Participants
NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 5.5mg testosterone per actuation.
For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.
To be given three times daily (after Visit 4 \[Day 90\]) if symptoms not adequately managed on BID.
|
Non-naive Patients - ARM 2
n=77 Participants
NATESTO Testosterone Nasal Gel administered intranasally to patients who had prior TRT. Multiple-dose dispenser will be used for gel deposition into the nasal cavity. The dispenser is a finger-actuated, non-pressurized dispensing system designed to deliver 5.5mg testosterone per actuation.
For BID administration, NATESTO 22 mg/day of testosterone. For the subset of patients that continue on TID, NATESTO 33 mg/day of testosterone.
To be given three times daily (after Visit 4 \[Day 90\]) if symptoms not adequately managed on BID.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
52.9 years
STANDARD_DEVIATION 8.2 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 9.0 • 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
|
23 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
100 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
|
2 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
88 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
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and 3 months for BID, 4 months for TIDThe primary objective of this study is to measure patient satisfaction with testosterone replacement therapy before, during and after treatment with NATESTO. Patient satisfaction with treatment will be measured by TSQM (Treatment Satisfaction Questionnaire for Medication) Version 9, a 9-item validated instrument. TSQM domains include - Effectiveness, Convenience, Global Satisfaction. The score for each domain is converted into a scale out of 100. Higher values imply a better outcome.
Outcome measures
| Measure |
Natesto Testosterone Intranasal Gel Given BID
n=47 Participants
Patients who completed 90 days on BID NATESTO.
|
Natesto Testosterone Intranasal Gel Given TID
n=15 Participants
Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
|
Non-naive Patients - TID Treatment
NATESTO Testosterone Nasal Gel administered intranasally to patients previously on TRT.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
Naive Patients - TID Treatment
NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
|---|---|---|---|---|
|
Patient Satisfaction - Change From Baseline
Effectiveness Domain Change from Baseline
|
9.6 Units on a scale
Standard Deviation 25.9
|
21.5 Units on a scale
Standard Deviation 14.4
|
—
|
—
|
|
Patient Satisfaction - Change From Baseline
Convenience Domain Change from Baseline
|
18.9 Units on a scale
Standard Deviation 21.4
|
21.9 Units on a scale
Standard Deviation 24.8
|
—
|
—
|
|
Patient Satisfaction - Change From Baseline
Global Satisfaction Domain Change from Baseline
|
-0.6 Units on a scale
Standard Deviation 33.0
|
13.3 Units on a scale
Standard Deviation 22.9
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 3 months for BID, 4 months for TIDPopulation: ITT population, no-LOCF
Change in hypogonadism symptoms from baseline as measured by qADAM, a 10 point validated instrument. qADAM is a 10-item, patient-reported outcome measure used to evaluate the symptom severity of hypogonadism. Responses can range from 1 to 5 per question allowing for a minimum to maximum score range of 10 to 50. Higher values imply a better outcome.
Outcome measures
| Measure |
Natesto Testosterone Intranasal Gel Given BID
n=47 Participants
Patients who completed 90 days on BID NATESTO.
|
Natesto Testosterone Intranasal Gel Given TID
n=7 Participants
Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
|
Non-naive Patients - TID Treatment
n=15 Participants
NATESTO Testosterone Nasal Gel administered intranasally to patients previously on TRT.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
Naive Patients - TID Treatment
n=12 Participants
NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
|---|---|---|---|---|
|
Change in Hypogonadism Symptoms
|
4.8 Units on a scale
Standard Deviation 6.5
|
12.0 Units on a scale
Standard Deviation 3.9
|
3.9 Units on a scale
Standard Deviation 3.8
|
6.8 Units on a scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Last visit, i.e. 3 months for BID, 4 months for TIDPopulation: Number of participants includes BID and TID patients for each Arm. The number is different than the total number of patients who completed because some subjects did not provide a response to this question.
Patient treatment preference versus prior testosterone replacement therapy measured by the Treatment Preference questionnaire.
Outcome measures
| Measure |
Natesto Testosterone Intranasal Gel Given BID
n=18 Participants
Patients who completed 90 days on BID NATESTO.
|
Natesto Testosterone Intranasal Gel Given TID
n=54 Participants
Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
|
Non-naive Patients - TID Treatment
NATESTO Testosterone Nasal Gel administered intranasally to patients previously on TRT.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
Naive Patients - TID Treatment
NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
|---|---|---|---|---|
|
Patient Treatment Preference Versus Prior Testosterone Replacement Therapy
Yes, I plan to continue taking NATESTO
|
10 Participants
|
32 Participants
|
—
|
—
|
|
Patient Treatment Preference Versus Prior Testosterone Replacement Therapy
I am undecided if I will continue NATESTO
|
5 Participants
|
12 Participants
|
—
|
—
|
|
Patient Treatment Preference Versus Prior Testosterone Replacement Therapy
No, I do not plan to continue taking NATESTO
|
3 Participants
|
10 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 months for those who remained on BID, 4 months for those uptitrated to TIDPopulation: ITT population
Frequency of daily dosing, i.e. how many patients remained on BID vs how many were uptitrated to TID by the end of the study.
Outcome measures
| Measure |
Natesto Testosterone Intranasal Gel Given BID
n=23 Participants
Patients who completed 90 days on BID NATESTO.
|
Natesto Testosterone Intranasal Gel Given TID
n=77 Participants
Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
|
Non-naive Patients - TID Treatment
NATESTO Testosterone Nasal Gel administered intranasally to patients previously on TRT.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
Naive Patients - TID Treatment
NATESTO Testosterone Nasal Gel administered intranasally to patients with no prior TRT experience.
Patients whose symptoms were not adequately controlled on BID treatment at Study Day 90 were switched to TID (33 mg/day) for 30 days. Change in scores is between Day 120 and Baseline.
|
|---|---|---|---|---|
|
Frequency of Daily Dose of NATESTO by the End of the Study
BID
|
10 Participants
|
60 Participants
|
—
|
—
|
|
Frequency of Daily Dose of NATESTO by the End of the Study
TID
|
13 Participants
|
17 Participants
|
—
|
—
|
Adverse Events
Natesto Testosterone Intranasal Gel Given BID
Serious events: 1 serious events
Other events: 22 other events
Deaths: 0 deaths
Natesto Testosterone Intranasal Gel Given TID
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Natesto Testosterone Intranasal Gel Given BID
n=87 participants at risk
Patients who completed 90 days on BID NATESTO.
|
Natesto Testosterone Intranasal Gel Given TID
n=30 participants at risk
Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal Cancer
|
1.1%
1/87 • 90 or 120 days
|
0.00%
0/30 • 90 or 120 days
|
Other adverse events
| Measure |
Natesto Testosterone Intranasal Gel Given BID
n=87 participants at risk
Patients who completed 90 days on BID NATESTO.
|
Natesto Testosterone Intranasal Gel Given TID
n=30 participants at risk
Patients who completed 90 days on BID NATESTO and were then switched to TID treatment for an additional 30 days.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
4.6%
4/87 • Number of events 5 • 90 or 120 days
|
3.3%
1/30 • Number of events 1 • 90 or 120 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Discomfort
|
4.6%
4/87 • Number of events 4 • 90 or 120 days
|
0.00%
0/30 • 90 or 120 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
3.4%
3/87 • Number of events 3 • 90 or 120 days
|
6.7%
2/30 • Number of events 2 • 90 or 120 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Dryness
|
2.3%
2/87 • Number of events 2 • 90 or 120 days
|
0.00%
0/30 • 90 or 120 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.3%
2/87 • Number of events 2 • 90 or 120 days
|
6.7%
2/30 • Number of events 2 • 90 or 120 days
|
|
Gastrointestinal disorders
Dysgeusia
|
3.4%
3/87 • Number of events 3 • 90 or 120 days
|
0.00%
0/30 • 90 or 120 days
|
|
Vascular disorders
Epistaxis
|
5.7%
5/87 • Number of events 5 • 90 or 120 days
|
0.00%
0/30 • 90 or 120 days
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.1%
1/87 • Number of events 1 • 90 or 120 days
|
6.7%
2/30 • Number of events 4 • 90 or 120 days
|
Additional Information
Dr. Nathan Bryson, Chief Scientific Officer
Acerus Pharmaceuticals Corporation
Phone: 1-416-679-0776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place