ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy of an Intranasal Testosterone Product

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: NCT01252745
Recruitment Status : Completed
First Posted : December 3, 2010
Results First Posted : April 26, 2018
Last Update Posted : May 23, 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: Hypogonadism
Interventions: Drug: 10.0 mg of Testosterone, 4.0% TID
Drug: 13.5 mg of Testosterone, 4.5% B.I.D
Drug: 11.25 mg of Testosterone, 4.5% T.I.D

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
10.0 mg Testosterone t.i.d. TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
13.5 mg Testosterone b.i.d. TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
11.25 mg Testosterone t.i.d. TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)

Participant Flow:   Overall Study
    10.0 mg Testosterone t.i.d.   13.5 mg Testosterone b.i.d.   11.25 mg Testosterone t.i.d.
STARTED   8   7   7 
COMPLETED   8   7   7 
NOT COMPLETED   0   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
10.0 mg Testosterone t.i.d. TBS-1 syringes pre-filled with 125 μL 4.0% gel to deliver 5.0 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 30 mg/day)
13.5 mg Testosterone b.i.d. TBS-1 syringes pre-filled with 150 μL 4.5% gel to deliver 6.75 mg of Testosterone per nostril (intra-nasal) given b.i.d. at 2100 and 0700 hours. (total dose 27.0 mg/day)
11.25 mg Testosterone t.i.d. TBS-1 syringes pre-filled with 125 μL 4.5% gel to deliver 5.625 mg of Testosterone per nostril (intra-nasal) given t.i.d. at 2100, 0700, and 1300 hours. (total dose 33.75 mg/day)
Total Total of all reporting groups

Baseline Measures
   10.0 mg Testosterone t.i.d.   13.5 mg Testosterone b.i.d.   11.25 mg Testosterone t.i.d.   Total 
Overall Participants Analyzed 
[Units: Participants]
 8   7   7   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.38  (12.55)   53.86  (11.04)   51.57  (9.90)   52.59  (10.78) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      8 100.0%      7 100.0%      7 100.0%      22 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
       
Hispanic or Latino      4  50.0%      3  42.9%      3  42.9%      10  45.5% 
Not Hispanic or Latino      4  50.0%      4  57.1%      4  57.1%      12  54.5% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      1  14.3%      1   4.5% 
White      8 100.0%      7 100.0%      6  85.7%      21  95.5% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
       
United States   8   7   7   22 


  Outcome Measures

1.  Primary:   Cmax of Serum Testosterone   [ Time Frame: 24 hours ]

2.  Primary:   Cavg of Serum Testosterone   [ Time Frame: 24 hours ]

3.  Primary:   AUC0-t of Serum Testosterone   [ Time Frame: 24 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Vice President
Organization: Acerus Pharmaceuticals Corporation
phone: (416) 679-0776
e-mail: nbryson@aceruspharma.com



Responsible Party: Acerus Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01252745     History of Changes
Other Study ID Numbers: TBS-1-2010-01
First Submitted: December 1, 2010
First Posted: December 3, 2010
Results First Submitted: February 15, 2018
Results First Posted: April 26, 2018
Last Update Posted: May 23, 2018