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Trial record 1 of 1 for:    NCT01228071
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Time to Eugonadal Range, Time to Steady State and Drying Time

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ClinicalTrials.gov Identifier: NCT01228071
Recruitment Status : Completed
First Posted : October 25, 2010
Results First Posted : July 22, 2013
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Male Hypogonadism
Intervention Drug: testosterone gel 2%
Enrollment 34
Recruitment Details This multicenter, open-label, single-arm phase 3B trial was initiated on November 9, 2010 and completed on May 6, 2011 in the United States.
Pre-assignment Details After the 3-week screening period and fulfilling the eligibility criteria, 34 hypogonadal men were enrolled in the study.
Arm/Group Title 40 mg Daily Dose of Testosterone Gel 2%
Hide Arm/Group Description

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%

Period Title: Overall Study
Started 34
Completed 32
Not Completed 2
Reason Not Completed
Protocol Violation             1
Withdrawal by Subject             1
Arm/Group Title 40 mg Daily Dose of Testosterone Gel 2%
Hide Arm/Group Description

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%

Overall Number of Baseline Participants 34
Hide Baseline Analysis Population Description
The pharmacokinetic (PK) population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data. All subjects who received at least 1 dose of study drug were included in the safety population.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
<=18 years
0
   0.0%
Between 18 and 65 years
34
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants
51.8  (10.01)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants
Female
0
   0.0%
Male
34
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 34 participants
34
1.Primary Outcome
Title Time to Target Eugonadal Range
Hide Description The time to eugonadal range (ie, testosterone ≥300 ng/dL) was assessed based on the 24-hour PK serum concentration data.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 31 subjects in the PK population, 7 subjects were not included in the analysis for time to eugonadal range. Five (5) subjects had total testosterone serum concentrations of ≥300 ng/dL at Visit 2 (baseline, time 0) and 2 subjects had total testosterone serum concentrations that never reached 300 ng/dL.
Arm/Group Title 40 mg Daily Dose of Testosterone Gel 2%
Hide Arm/Group Description:

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%

Overall Number of Participants Analyzed 24
Median (95% Confidence Interval)
Unit of Measure: hours
2.85
(1.91 to 4.25)
2.Primary Outcome
Title Time to Steady State (SS)
Hide Description Trough total testosterone levels were obtained at Day 2, Day 3, Day 4, Day 7, and Day 14 to assess time to steady state. Trough concentrations over the 14-day period were used to calculate time SS.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.
Arm/Group Title 40 mg Daily Dose of Testosterone Gel 2%
Hide Arm/Group Description:

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%

Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: days
1.13
(0.68 to 3.40)
3.Primary Outcome
Title Gel Drying Time
Hide Description Testosterone gel 2% drying time was assessed with a stopwatch. On Day 14 at the time of application of the gel directly to the first anteromedial thigh, the subject started a stopwatch. The gel was spread as evenly as possible over an area of 1 g/100 cm2. The total coverage area on the thigh was approximately equal to two (2) 3"× 5" postcards. The subject gently rubbed the gel with his fingertip in a circular motion (avoiding contact with the scrotal region) until the gel was dry. At this time, the stopwatch was stopped and the time expended was recorded in the eCRF.
Time Frame 1 day; drying time measured following gel application on Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
The PK population consisted of all subjects who had a drug drying time, required trough concentrations values, and no protocol violations significantly affecting the PK data.
Arm/Group Title 40 mg Daily Dose of Testosterone Gel 2%
Hide Arm/Group Description:

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%

Overall Number of Participants Analyzed 31
Median (95% Confidence Interval)
Unit of Measure: minutes
2.4
(1.7 to 3.4)
Time Frame Approximately two weeks plus 21 days: AE data were collected from Screening (Day -21 to Day -1) through Day 14/End of Study(EOS).
Adverse Event Reporting Description All AEs were recorded in the eCRF, including any new (or increased severity of) signs, symptoms, injury, or illness. AEs that occurred up to 14 days following the last dose of study medication were recorded on the CRF/eCRF. Any AE that was ongoing at completion/termination of the study was followed until resolution or up to 14 days.
 
Arm/Group Title EN3350 (Testosterone Gel 2%)
Hide Arm/Group Description

testosterone gel 2%

testosterone gel 2% : 40 mg testosterone gel 2%

All-Cause Mortality
EN3350 (Testosterone Gel 2%)
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
EN3350 (Testosterone Gel 2%)
Affected / at Risk (%)
Total   0/34 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
EN3350 (Testosterone Gel 2%)
Affected / at Risk (%)
Total   6/34 (17.65%) 
Gastrointestinal disorders   
Diarrhoea * 1  1/34 (2.94%) 
General disorders   
Application site dryness * 1  1/34 (2.94%) 
Application site rash * 1  1/34 (2.94%) 
Nervous system disorders   
Headache * 1  1/34 (2.94%) 
Respiratory, thoracic and mediastinal disorders   
Productive cough * 1  1/34 (2.94%) 
Throat irritation * 1  1/34 (2.94%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  1/34 (2.94%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA (13.0)
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: Clinical Trial Coordinator
Organization: Endo Pharmaceutical, Inc.
EMail: clinicalsite.inquiries@endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01228071    
Other Study ID Numbers: EN3350-302
First Submitted: October 22, 2010
First Posted: October 25, 2010
Results First Submitted: March 27, 2013
Results First Posted: July 22, 2013
Last Update Posted: October 5, 2017