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A Clinical Study to Evaluate the Pharmacokinetics of Testosterone Gel Using an Applicator

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01464879
First received: November 1, 2011
Last updated: August 15, 2017
Last verified: August 2017
Results First Received: June 29, 2017  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Hypogonadal Males
Intervention: Drug: Testosterone Gel (FE 999303)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study was conducted at one study site in the US. Out of 78 subjects screened, 20 subjects were enrolled in the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Apart from having history of hypogonadism, the study subjects were required to present with one or more symptoms of testosterone deficiency (i.e. fatigue, decreased muscle mass, reduced libido, reduced sexual functioning of a non-mechanical nature). The study subjects needed to be in good health despite exhibiting hypogonadism.

Reporting Groups
  Description
Testosterone Topical Initially subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.

Participant Flow:   Overall Study
    Testosterone Topical
STARTED   20 
Hand Application (2.50 mL)   20 
Washout Period   20 
Applicator Application (1.25 mL)   19 [1] 
Applicator Application (2.50 mL)   18 [2] 
Applicator Application (3.75 mL)   18 
COMPLETED   18 
NOT COMPLETED   2 
Physician Decision                1 
Non-compliance                1 
[1] One subject discontinued due to non-compliance.
[2] One subject discontinued due to physician's decision.



  Baseline Characteristics
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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.
The data are presented for Intent-to-treat (ITT) population, which comprised of all subjects who received at least one dose of the Investigational Medicinal Product (IMP).

Reporting Groups
  Description
Testosterone Topical Initially study subjects self-applied 2.50 mL (two strokes) of testosterone gel by hand every day for seven days followed by a 7-day washout period. After washout period, study subjects sequentially self-applied ascending doses of testosterone gel with the applicator; 1.25 mL (one stroke), 2.50 mL (two strokes), and 3.75 mL (three strokes), respectively every day for seven days with no washout period in between.

Baseline Measures
   Testosterone Topical 
Overall Participants Analyzed 
[Units: Participants]
 20 
Age 
[Units: Year]
Mean (Standard Deviation)
 52.1  (8.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      20 100.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      1   5.0% 
Not Hispanic or Latino      19  95.0% 
Unknown or Not Reported      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      2  10.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      6  30.0% 
White      12  60.0% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 
Region of Enrollment 
[Units: Subjects]
 
United States   20 
Height 
[Units: Inch]
Mean (Standard Deviation)
 69.2  (2.7) 
Weight 
[Units: Lbs]
Mean (Standard Deviation)
 203.7  (29.9) 
Body Mass Index (BMI) 
[Units: Kg/m^2]
Mean (Standard Deviation)
 29.8  (3.1) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Responder Rate: Percentage of Subjects Whose Average Steady State Concentration (Cavg) of Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With Each of Three Volumes of FE 999303 Applied With an Applicator.   [ Time Frame: Days 15-21, Days 22-28 & Days 29-35 ]

2.  Secondary:   Responder Rate: Percentage of Subjects Whose Cavg Serum Total Testosterone Levels Are Between 300 and 1050 ng/dL Following Treatment With One Volume of FE 999303 Applied by Hand.   [ Time Frame: Days 1-7 ]

3.  Secondary:   Pharmacokinetics of Total Testosterone and DHT (Dihydrotestosterone) Measuring Area Under the Concentration-time Curve From the Last Dose and 24 Hrs. Post Dose (AUCτ)   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]

4.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Time of Maximum Observed Concentration (Tmax)   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]

5.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Maximum Concentration Observed (Cmax)   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]

6.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Cavg   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]

7.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Minimum Concentration Observed (Cmin)   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]

8.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Time of Minimum Observed Concentration (Tmin)   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 21, Day 28 & Day 35 of testosterone gel application through applicator ]

9.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring AUCτ   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]

10.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Tmax   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]

11.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Cmax   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]

12.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Cavg   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]

13.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Cmin   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]

14.  Secondary:   Pharmacokinetics of Total Testosterone and DHT Measuring Tmin   [ Time Frame: Samples were collected pre-dose and at 2, 4, 6, 8, 10, 12, and 24 hr post-dose on Day 7 of testosterone gel application through hand ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Development Support
Organization: Ferring Pharmaceuticals
e-mail: DK0-Disclosure@ferring.com



Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01464879     History of Changes
Other Study ID Numbers: 000024
Study First Received: November 1, 2011
Results First Received: June 29, 2017
Last Updated: August 15, 2017