Trial Outcomes & Findings for Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism (NCT NCT01446042)
NCT ID: NCT01446042
Last Updated: 2018-06-13
Results Overview
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
306 participants
Primary outcome timeframe
90 days
Results posted on
2018-06-13
Participant Flow
Participant milestones
| Measure |
TBS-1 - b.i.d.
Intranasal testosterone given b.i.d.
|
TBS-1 b.i.d./t.i.d
Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
|
TBS-1 - t.i.d.
Intranasal testosterone given t.i.d.
|
|---|---|---|---|
|
Overall Study
STARTED
|
142
|
86
|
78
|
|
Overall Study
COMPLETED
|
122
|
83
|
69
|
|
Overall Study
NOT COMPLETED
|
20
|
3
|
9
|
Reasons for withdrawal
| Measure |
TBS-1 - b.i.d.
Intranasal testosterone given b.i.d.
|
TBS-1 b.i.d./t.i.d
Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
|
TBS-1 - t.i.d.
Intranasal testosterone given t.i.d.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
12
|
2
|
4
|
|
Overall Study
Adverse Event
|
1
|
0
|
4
|
|
Overall Study
Lost to Follow-up
|
5
|
0
|
0
|
|
Overall Study
Other reasons
|
2
|
1
|
1
|
Baseline Characteristics
Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism
Baseline characteristics by cohort
| Measure |
TBS-1 - b.i.d.
n=142 Participants
Intranasal testosterone given b.i.d.
|
TBS-1 - b.i.d./t.i.d.
n=86 Participants
Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
|
TBS-1 - t.i.d.
n=78 Participants
Intranasal testosterone given t.i.d.
|
Total
n=306 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
121 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
246 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
142 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
306 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
142 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
306 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 90 daysPopulation: Per-Protocol Population
The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
Outcome measures
| Measure |
TBS-1 - b.i.d.
n=102 Participants
5.5 mg per nostril of 4.5% TBS-1 BID
Testosterone: Intranasal testosterone
|
TBS-1 - b.i.d./t.i.d.
n=68 Participants
Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
|
TBS-1 - t.i.d.
n=67 Participants
5.5 mg per nostril of 4.5% TBS-1 TID
Testosterone: Intranasal testosterone
|
|---|---|---|---|
|
Serum Testosterone Cavg
|
76 Participants
|
43 Participants
|
61 Participants
|
SECONDARY outcome
Timeframe: 90 daysPopulation: ITT subjects who have a Cmax value at the specified visit.
To determine the efficacy of 4.5% TBS-1 gel, administered 2 or 3 times daily at a dose of 5.5 mg per nostril, in achieving the following serum total testosterone maximum concentration (Cmax) on Day 90: * A Cmax (maximum testosterone concentration) value of 1500 ng/dL or more in at least 85% of the participants analyzed * A Cmax (maximum testosterone concentration) value of 1800 to 2500 ng/dL in fewer than 5% of participants analyzed * No analyzed participants with a Cmax (maximum testosterone concentration) \>2500 ng/dL
Outcome measures
| Measure |
TBS-1 - b.i.d.
n=114 Participants
5.5 mg per nostril of 4.5% TBS-1 BID
Testosterone: Intranasal testosterone
|
TBS-1 - b.i.d./t.i.d.
n=79 Participants
Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
|
TBS-1 - t.i.d.
n=59 Participants
5.5 mg per nostril of 4.5% TBS-1 TID
Testosterone: Intranasal testosterone
|
|---|---|---|---|
|
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
Cmax <=1500 ng/dL
|
107 Participants
|
77 Participants
|
58 Participants
|
|
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
1800 ng/dL <= Cmax <=2500 ng/dL
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
Cmax >2500 ng/dL
|
1 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
TBS-1 - b.i.d.
Serious events: 2 serious events
Other events: 65 other events
Deaths: 0 deaths
TBS-1 - b.i.d./t.i.d.
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
TBS-1 - t.i.d.
Serious events: 2 serious events
Other events: 46 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
TBS-1 - b.i.d.
n=142 participants at risk
Intranasal testosterone given b.i.d.
|
TBS-1 - b.i.d./t.i.d.
n=86 participants at risk
Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
|
TBS-1 - t.i.d.
n=78 participants at risk
Intranasal testosterone given t.i.d.
|
|---|---|---|---|
|
Injury, poisoning and procedural complications
Internal injury
|
0.00%
0/142 • 1 year
|
0.00%
0/86 • 1 year
|
1.3%
1/78 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/142 • 1 year
|
0.00%
0/86 • 1 year
|
1.3%
1/78 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Abdominal mass
|
0.00%
0/142 • 1 year
|
0.00%
0/86 • 1 year
|
1.3%
1/78 • Number of events 1 • 1 year
|
|
Injury, poisoning and procedural complications
Fall
|
0.70%
1/142 • Number of events 1 • 1 year
|
0.00%
0/86 • 1 year
|
0.00%
0/78 • 1 year
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.70%
1/142 • Number of events 1 • 1 year
|
0.00%
0/86 • 1 year
|
0.00%
0/78 • 1 year
|
|
Injury, poisoning and procedural complications
Ligament Rapture
|
0.70%
1/142 • Number of events 1 • 1 year
|
0.00%
0/86 • 1 year
|
0.00%
0/78 • 1 year
|
|
Cardiac disorders
Acute Coronary Syndrome
|
0.00%
0/142 • 1 year
|
1.2%
1/86 • Number of events 1 • 1 year
|
0.00%
0/78 • 1 year
|
Other adverse events
| Measure |
TBS-1 - b.i.d.
n=142 participants at risk
Intranasal testosterone given b.i.d.
|
TBS-1 - b.i.d./t.i.d.
n=86 participants at risk
Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45
|
TBS-1 - t.i.d.
n=78 participants at risk
Intranasal testosterone given t.i.d.
|
|---|---|---|---|
|
Gastrointestinal disorders
Retching
|
0.00%
0/142 • 1 year
|
2.3%
2/86 • 1 year
|
0.00%
0/78 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.70%
1/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
General disorders
Chills
|
0.00%
0/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
General disorders
Pyrexia
|
0.00%
0/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Infections and infestations
Nasopharyngitis
|
2.8%
4/142 • 1 year
|
4.7%
4/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Infections and infestations
Bronchitis
|
1.4%
2/142 • 1 year
|
0.00%
0/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/142 • 1 year
|
1.2%
1/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Infections and infestations
Upper respiratory tract infection
|
0.70%
1/142 • 1 year
|
0.00%
0/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Infections and infestations
Sinusitis
|
0.00%
0/142 • 1 year
|
0.00%
0/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.70%
1/142 • 1 year
|
0.00%
0/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Investigations
PSA increased
|
0.00%
0/142 • 1 year
|
2.3%
2/86 • 1 year
|
5.1%
4/78 • 1 year
|
|
Investigations
Blood CPK increased
|
0.70%
1/142 • 1 year
|
2.3%
2/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Investigations
Blood pressure increased
|
0.00%
0/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.70%
1/142 • 1 year
|
0.00%
0/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Investigations
Weight increased
|
0.00%
0/142 • 1 year
|
2.3%
2/86 • 1 year
|
0.00%
0/78 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.8%
4/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.70%
1/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/142 • 1 year
|
0.00%
0/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Nervous system disorders
Parosmia
|
4.9%
7/142 • 1 year
|
3.5%
3/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Nervous system disorders
Headache
|
1.4%
2/142 • 1 year
|
0.00%
0/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Nervous system disorders
Dysgeusia
|
0.70%
1/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
8/142 • 1 year
|
9.3%
8/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.2%
6/142 • 1 year
|
5.8%
5/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
4.2%
6/142 • 1 year
|
2.3%
2/86 • 1 year
|
3.8%
3/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.5%
5/142 • 1 year
|
3.5%
3/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
4.2%
6/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Nasal mucosal disorder
|
2.8%
4/142 • 1 year
|
0.00%
0/86 • 1 year
|
0.00%
0/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.70%
1/142 • 1 year
|
2.3%
2/86 • 1 year
|
1.3%
1/78 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/142 • 1 year
|
1.2%
1/86 • 1 year
|
2.6%
2/78 • 1 year
|
|
Skin and subcutaneous tissue disorders
Scab
|
2.1%
3/142 • 1 year
|
2.3%
2/86 • 1 year
|
3.8%
3/78 • 1 year
|
Additional Information
Natalia Tkachenko, MD Director Clinical Affairs
Trimel Pharmaceuticals Corp.
Phone: 9054641755
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place