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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | 2% testosterone gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Testosterone | Drug | 2% gel |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 | Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 |
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Inclusion Criteria:
Men aged 18 - 75 years with primary or secondary hypogonadism as confirmed by:
Has a BMI ≥ 22 kg/m2 and < 35 kg/m2.
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| Name | Affiliation | Role |
|---|---|---|
| Liz Waldie | Strakan Pharmaceuticals, Inc. | Study Director |
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Of 406 participants screened, 149 met the inclusion/exclusion criteria and entered the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fortigel | 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled participants
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| ID | Title | Description |
|---|---|---|
| BG000 | Fortigel | 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants Meeting Serum Total Testosterone Average Concentration (Cavg) Criteria at Day 90 | Percentage of participants with Cavg0-24h ≥300-≤1140 ng/dL | 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 | Posted | Number | 95% Confidence Interval | percentage of participants | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 |
|
Throughout the study (approximately 93 days)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fortigel | 40 mg testosterone in 2 g gel applied topically once daily for 90 days (adjusted to between 10 and 70 mg per day) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intestinal obstruction | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin reaction | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Coordinator | Endo Pharmaceuticals Inc. | clinicalsite.inquiries@endo.com |
| ID | Term |
|---|---|
| D007006 | Hypogonadism |
| ID | Term |
|---|---|
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Subject non-compliance |
|
| Other/unknown |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Percentage of Participants Meeting Serum Total Testosterone Maximum Concentration (Cmax) Criteria at Day 90 | Percentage of participants with Cmax ≤1500 ng/dL, 1800-2500 ng/dL, and >2500 ng/dL | 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 | Posted | Number | percentage of participants | 0, 0.5, 1, 2, 4, 6, 8, 10, 12 and 24 hours after study drug application on day 90 |
|
|
|
| 5 |
| 149 |
| 67 |
| 149 |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA | Non-systematic Assessment |
|
| Prostatic specific antigen increased | Investigations | MedDRA | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA | Non-systematic Assessment |
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| Abnormal dreams | Psychiatric disorders | MedDRA | Non-systematic Assessment |
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Publication statement in clinical trial agreement
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045165 | Testosterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| Title | Measurements |
|---|---|
|