Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 45 of 213 for:    "Hypogonadism" | "Androgens"

Safety and Efficacy of Intranasal TBS-1 Treatment of Male Hypogonadism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01446042
Recruitment Status : Completed
First Posted : October 4, 2011
Results First Posted : June 13, 2018
Last Update Posted : June 13, 2018
Sponsor:
Information provided by (Responsible Party):
Acerus Pharmaceuticals Corporation

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Male Hypogonadism
Intervention Drug: Testosterone
Enrollment 306
Recruitment Details  
Pre-assignment Details  
Arm/Group Title TBS-1 - b.i.d. TBS-1 b.i.d./t.i.d TBS-1 - t.i.d.
Hide Arm/Group Description Intranasal testosterone given b.i.d. Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45 Intranasal testosterone given t.i.d.
Period Title: Overall Study
Started 142 86 78
Completed 122 83 69
Not Completed 20 3 9
Reason Not Completed
Withdrawal by Subject             12             2             4
Adverse Event             1             0             4
Lost to Follow-up             5             0             0
Other reasons             2             1             1
Arm/Group Title TBS-1 - b.i.d. TBS-1 - b.i.d./t.i.d. TBS-1 - t.i.d. Total
Hide Arm/Group Description Intranasal testosterone given b.i.d. Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45 Intranasal testosterone given t.i.d. Total of all reporting groups
Overall Number of Baseline Participants 142 86 78 306
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 86 participants 78 participants 306 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
121
  85.2%
64
  74.4%
61
  78.2%
246
  80.4%
>=65 years
21
  14.8%
22
  25.6%
17
  21.8%
60
  19.6%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants 86 participants 78 participants 306 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
142
 100.0%
86
 100.0%
78
 100.0%
306
 100.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 142 participants 86 participants 78 participants 306 participants
142
 100.0%
86
 100.0%
78
 100.0%
306
 100.0%
1.Primary Outcome
Title Serum Testosterone Cavg
Hide Description The percentage of patients with an average serum total testosterone concentration (Cavg) within the normal range (300 to 1050 ng/dL)
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
Per-Protocol Population
Arm/Group Title TBS-1 - b.i.d. TBS-1 - b.i.d./t.i.d. TBS-1 - t.i.d.
Hide Arm/Group Description:

5.5 mg per nostril of 4.5% TBS-1 BID

Testosterone: Intranasal testosterone

Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45

5.5 mg per nostril of 4.5% TBS-1 TID

Testosterone: Intranasal testosterone

Overall Number of Participants Analyzed 102 68 67
Measure Type: Count of Participants
Unit of Measure: Participants
76
  74.5%
43
  63.2%
61
  91.0%
2.Secondary Outcome
Title Patients With a Certain Serum Total Testosterone Maximum Concentration on Day 90
Hide Description

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
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
ITT subjects who have a Cmax value at the specified visit.
Arm/Group Title TBS-1 - b.i.d. TBS-1 - b.i.d./t.i.d. TBS-1 - t.i.d.
Hide Arm/Group Description:

5.5 mg per nostril of 4.5% TBS-1 BID

Testosterone: Intranasal testosterone

Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45

5.5 mg per nostril of 4.5% TBS-1 TID

Testosterone: Intranasal testosterone

Overall Number of Participants Analyzed 114 79 59
Measure Type: Count of Participants
Unit of Measure: Participants
Cmax <=1500 ng/dL
107
  93.9%
77
  97.5%
58
  98.3%
1800 ng/dL <= Cmax <=2500 ng/dL
6
   5.3%
2
   2.5%
1
   1.7%
Cmax >2500 ng/dL
1
   0.9%
0
   0.0%
0
   0.0%
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TBS-1 - b.i.d. TBS-1 - b.i.d./t.i.d. TBS-1 - t.i.d.
Hide Arm/Group Description Intranasal testosterone given b.i.d. Subjects on b.i.d. who were uptitrated to t.i.d. on Day 45 Intranasal testosterone given t.i.d.
All-Cause Mortality
TBS-1 - b.i.d. TBS-1 - b.i.d./t.i.d. TBS-1 - t.i.d.
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/142 (0.00%)      0/86 (0.00%)      1/78 (1.28%)    
Show Serious Adverse Events Hide Serious Adverse Events
TBS-1 - b.i.d. TBS-1 - b.i.d./t.i.d. TBS-1 - t.i.d.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/142 (1.41%)      1/86 (1.16%)      2/78 (2.56%)    
Cardiac disorders       
Acute Coronary Syndrome  1  0/142 (0.00%)  0 1/86 (1.16%)  1 0/78 (0.00%)  0
Gastrointestinal disorders       
Abdominal mass  1  0/142 (0.00%)  0 0/86 (0.00%)  0 1/78 (1.28%)  1
Injury, poisoning and procedural complications       
Internal injury  1  0/142 (0.00%)  0 0/86 (0.00%)  0 1/78 (1.28%)  1
Road traffic accident  1  0/142 (0.00%)  0 0/86 (0.00%)  0 1/78 (1.28%)  1
Fall  1  1/142 (0.70%)  1 0/86 (0.00%)  0 0/78 (0.00%)  0
Hip Fracture  1  1/142 (0.70%)  1 0/86 (0.00%)  0 0/78 (0.00%)  0
Ligament Rapture  1  1/142 (0.70%)  1 0/86 (0.00%)  0 0/78 (0.00%)  0
1
Term from vocabulary, MedDRA (14.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
TBS-1 - b.i.d. TBS-1 - b.i.d./t.i.d. TBS-1 - t.i.d.
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   65/142 (45.77%)      40/86 (46.51%)      46/78 (58.97%)    
Gastrointestinal disorders       
Retching  1  0/142 (0.00%)  2/86 (2.33%)  0/78 (0.00%) 
Nausea  1  1/142 (0.70%)  1/86 (1.16%)  2/78 (2.56%) 
General disorders       
Chills  1  0/142 (0.00%)  1/86 (1.16%)  2/78 (2.56%) 
Pyrexia  1  0/142 (0.00%)  1/86 (1.16%)  2/78 (2.56%) 
Infections and infestations       
Nasopharyngitis  1  4/142 (2.82%)  4/86 (4.65%)  3/78 (3.85%) 
Bronchitis  1  2/142 (1.41%)  0/86 (0.00%)  3/78 (3.85%) 
Tooth abscess  1  0/142 (0.00%)  1/86 (1.16%)  3/78 (3.85%) 
Upper respiratory tract infection  1  1/142 (0.70%)  0/86 (0.00%)  3/78 (3.85%) 
Sinusitis  1  0/142 (0.00%)  0/86 (0.00%)  3/78 (3.85%) 
Injury, poisoning and procedural complications       
Muscle strain  1  1/142 (0.70%)  0/86 (0.00%)  2/78 (2.56%) 
Investigations       
PSA increased  1  0/142 (0.00%)  2/86 (2.33%)  4/78 (5.13%) 
Blood CPK increased  1  1/142 (0.70%)  2/86 (2.33%)  2/78 (2.56%) 
Blood pressure increased  1  0/142 (0.00%)  1/86 (1.16%)  2/78 (2.56%) 
Blood thyroid stimulating hormone increased  1  1/142 (0.70%)  0/86 (0.00%)  2/78 (2.56%) 
Weight increased  1  0/142 (0.00%)  2/86 (2.33%)  0/78 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain  1  4/142 (2.82%)  1/86 (1.16%)  2/78 (2.56%) 
Arthralgia  1  1/142 (0.70%)  1/86 (1.16%)  2/78 (2.56%) 
Myalgia  1  0/142 (0.00%)  0/86 (0.00%)  2/78 (2.56%) 
Nervous system disorders       
Parosmia  1  7/142 (4.93%)  3/86 (3.49%)  2/78 (2.56%) 
Headache  1  2/142 (1.41%)  0/86 (0.00%)  3/78 (3.85%) 
Dysgeusia  1  1/142 (0.70%)  1/86 (1.16%)  2/78 (2.56%) 
Respiratory, thoracic and mediastinal disorders       
Rhinorrhoea  1  8/142 (5.63%)  8/86 (9.30%)  3/78 (3.85%) 
Epistaxis  1  6/142 (4.23%)  5/86 (5.81%)  3/78 (3.85%) 
Nasal discomfort  1  6/142 (4.23%)  2/86 (2.33%)  3/78 (3.85%) 
Nasal congestion  1  5/142 (3.52%)  3/86 (3.49%)  2/78 (2.56%) 
Nasal dryness  1  6/142 (4.23%)  1/86 (1.16%)  2/78 (2.56%) 
Nasal mucosal disorder  1  4/142 (2.82%)  0/86 (0.00%)  0/78 (0.00%) 
Upper-airway cough syndrome  1  1/142 (0.70%)  2/86 (2.33%)  1/78 (1.28%) 
Cough  1  0/142 (0.00%)  1/86 (1.16%)  2/78 (2.56%) 
Skin and subcutaneous tissue disorders       
Scab  1  3/142 (2.11%)  2/86 (2.33%)  3/78 (3.85%) 
1
Term from vocabulary, MedDRA (14.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Natalia Tkachenko, MD Director Clinical Affairs
Organization: Trimel Pharmaceuticals Corp.
Phone: 9054641755
EMail: ntkachenko@trimelpharmaceuticals.com
Layout table for additonal information
Responsible Party: Acerus Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01446042     History of Changes
Other Study ID Numbers: TBS-1-2011-03
First Submitted: September 30, 2011
First Posted: October 4, 2011
Results First Submitted: February 16, 2018
Results First Posted: June 13, 2018
Last Update Posted: June 13, 2018