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Trial record 80 of 213 for:    "Hypogonadism" | "Androgens"

A Study of Fortigel Testosterone Gel 2% in Males With Low Testosterone

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: NCT00522431
Recruitment Status : Completed
First Posted : August 29, 2007
Results First Posted : March 7, 2014
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Endo Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hypogonadism
Intervention Drug: Testosterone
Enrollment 149
Recruitment Details  
Pre-assignment Details Of 406 participants screened, 149 met the inclusion/exclusion criteria and entered the study.
Arm/Group Title Fortigel
Hide Arm/Group Description 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
Period Title: Overall Study
Started 149
Completed 138
Not Completed 11
Reason Not Completed
Adverse Event             5
Protocol Violation             2
Withdrawal by Subject             2
Subject non-compliance             1
Other/unknown             1
Arm/Group Title Fortigel
Hide Arm/Group Description 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
Overall Number of Baseline Participants 149
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 149 participants
54.5  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants
Female
0
   0.0%
Male
149
 100.0%
1.Primary Outcome
Title Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
Hide Description Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL
Time Frame 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis
Arm/Group Title Fortigel
Hide Arm/Group Description:
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
Overall Number of Participants Analyzed 129
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
77.5
(70.3 to 94.7)
2.Secondary Outcome
Title Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
Hide Description Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL
Time Frame 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90
Hide Outcome Measure Data
Hide Analysis Population Description
Modified intent-to-treat (mITT) population included participants who had more than 1 pharmacokinetic (PK) sample obtained during the 24-hour PK profile on day 90 (11 participants were excluded); data from 9 additional participants were excluded due to insufficient backup samples needed for reanalysis
Arm/Group Title Fortigel
Hide Arm/Group Description:
40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
Overall Number of Participants Analyzed 129
Measure Type: Number
Unit of Measure: percentage of participants
≤1500 ng/dL 94.6
1800-2500 ng/dL 1.6
>2500 ng/dL 0
Time Frame Throughout the study (approximately 93 days)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fortigel
Hide Arm/Group Description 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day)
All-Cause Mortality
Fortigel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Fortigel
Affected / at Risk (%)
Total   5/149 (3.36%) 
Gastrointestinal disorders   
Intestinal obstruction * 1  2/149 (1.34%) 
Rectal haemorrhage * 1  1/149 (0.67%) 
Infections and infestations   
Cellulitis * 1  1/149 (0.67%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Colon cancer * 1  1/149 (0.67%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnoea * 1  1/149 (0.67%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Fortigel
Affected / at Risk (%)
Total   67/149 (44.97%) 
Gastrointestinal disorders   
Diarrhoea * 1  3/149 (2.01%) 
Vomiting * 1  3/149 (2.01%) 
Abdominal pain * 1  2/149 (1.34%) 
Infections and infestations   
Upper respiratory tract infection * 1  10/149 (6.71%) 
Sinusitis * 1  6/149 (4.03%) 
Cellulitis * 1  2/149 (1.34%) 
Investigations   
Prostatic specific antigen increased * 1  2/149 (1.34%) 
Metabolism and nutrition disorders   
Hypocalcaemia * 1  2/149 (1.34%) 
Musculoskeletal and connective tissue disorders   
Arthralgia * 1  2/149 (1.34%) 
Back pain * 1  2/149 (1.34%) 
Muscle spasms * 1  2/149 (1.34%) 
Psychiatric disorders   
Abnormal dreams * 1  2/149 (1.34%) 
Renal and urinary disorders   
Haematuria * 1  2/149 (1.34%) 
Respiratory, thoracic and mediastinal disorders   
Cough * 1  3/149 (2.01%) 
Pharyngolaryngeal pain * 1  2/149 (1.34%) 
Skin and subcutaneous tissue disorders   
Skin reaction * 1  25/149 (16.78%) 
Rash * 1  2/149 (1.34%) 
Vascular disorders   
Hypertension * 1  4/149 (2.68%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA
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.
Publication statement in clinical trial agreement
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Trial Coordinator
Organization: Endo Pharmaceuticals Inc.
EMail: clinicalsite.inquiries@endo.com
Layout table for additonal information
Responsible Party: Endo Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00522431     History of Changes
Other Study ID Numbers: FOR01C
First Submitted: August 28, 2007
First Posted: August 29, 2007
Results First Submitted: January 24, 2014
Results First Posted: March 7, 2014
Last Update Posted: October 5, 2017