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

• Sponsor: Endo Pharmaceuticals (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00522431
• Collaborator: (none)
• Enrollment: 149
• Arm: 1
• Duration (Months): 7

Study Details

Study Description

Brief Summary

Low testosterone is a condition that occurs when the body is unable to produce sufficient quantities of testosterone. The medical name for low testosterone is hypogonadism. Hypogonadism can be caused by many factors. Symptoms include: decrease in libido, lack of energy and mood swings. The goal of testosterone replacement therapy is to return testosterone levels to the normal range and relieve symptoms.

The purpose of this study is to evaluate the ability of Fortigel testosterone gel 2% to maintain serum (blood) testosterone levels within the normal range in hypogonadal men aged 18 to 75 years. This will be determined by blood sampling at specified times during the study. The study is also intended to evaluate the tolerability of Fortigel, which will be applied to the skin each day throughout the study period.

Condition or Disease	Intervention/Treatment	Phase
Hypogonadism	Drug: Testosterone	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 149 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open Label Phase 3 Study of Fortigel Testosterone Gel 2% in Hypogonadal Males
• Study Start Date: Aug 1, 2007
• Actual Primary Completion Date: Mar 1, 2008
• Actual Study Completion Date: Mar 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 2% testosterone gel	Drug: Testosterone; 2% gel; Other Names: Fortigel

Outcome Measures

Primary Outcome Measures

1. Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 [0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90]

   Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL

Secondary Outcome Measures

1. Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 [0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90]

   Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:

• Single serum total testosterone concentration < 250 ng/dL, or

• Two consecutive serum total testosterone concentrations < 300 ng/dL (determined at least one week apart during the screening period).

• Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Endo Pharmaceuticals

Investigators

• Study Director: Liz Waldie, Strakan Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Endo Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00522431
• Other Study ID Numbers: FOR01C
• First Posted: Aug 29, 2007
• Last Update Posted: Oct 5, 2017
• Last Verified: Sep 1, 2017

• Keywords provided by Endo Pharmaceuticals: Hypogonadism
• Additional relevant MeSH terms: Hypogonadism; Testosterone

Study Results

Participant Flow

Pre-assignment Detail	Of 406 participants screened, 149 met the inclusion/exclusion criteria and entered the study.

Arm/Group Title	Fortigel
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

Baseline Characteristics

Arm/Group Title	Fortigel
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 Participants	149
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	54.5 (10.1)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	149 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90
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

Outcome Measure Data

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
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)
Measure Participants	129
Number (95% Confidence Interval) [percentage of participants]	77.5 52%

2. Secondary Outcome

Title	Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90
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

Outcome Measure Data

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
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)
Measure Participants	129
≤1500 ng/dL	94.6 63.5%
1800-2500 ng/dL	1.6 1.1%
>2500 ng/dL	0 0%

Adverse Events

Time Frame	Throughout the study (approximately 93 days)
Arm/Group Title	Fortigel
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 (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Fortigel
	Affected / at Risk (%)	# Events
Total	5/149 (3.4%)
Gastrointestinal disorders
Intestinal obstruction	2/149 (1.3%)
Rectal haemorrhage	1/149 (0.7%)
Infections and infestations
Cellulitis	1/149 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer	1/149 (0.7%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	1/149 (0.7%)
Other (Not Including Serious) Adverse Events
	Fortigel
	Affected / at Risk (%)	# Events
Total	67/149 (45%)
Gastrointestinal disorders
Diarrhoea	3/149 (2%)
Vomiting	3/149 (2%)
Abdominal pain	2/149 (1.3%)
Infections and infestations
Upper respiratory tract infection	10/149 (6.7%)
Sinusitis	6/149 (4%)
Cellulitis	2/149 (1.3%)
Investigations
Prostatic specific antigen increased	2/149 (1.3%)
Metabolism and nutrition disorders
Hypocalcaemia	2/149 (1.3%)
Musculoskeletal and connective tissue disorders
Arthralgia	2/149 (1.3%)
Back pain	2/149 (1.3%)
Muscle spasms	2/149 (1.3%)
Psychiatric disorders
Abnormal dreams	2/149 (1.3%)
Renal and urinary disorders
Haematuria	2/149 (1.3%)
Respiratory, thoracic and mediastinal disorders
Cough	3/149 (2%)
Pharyngolaryngeal pain	2/149 (1.3%)
Skin and subcutaneous tissue disorders
Skin reaction	25/149 (16.8%)
Rash	2/149 (1.3%)
Vascular disorders
Hypertension	4/149 (2.7%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Publication statement in clinical trial agreement