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Due to difficult patient enrollment.
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Heart failure (HF) is a complex condition resulting from structural or functional heart diseases that impair the ability of the heart to fill with or pump out blood. The main manifestations of HF are shortness of breath and tiredness which may limit the ability to exercise or perform simple daily physical activities such as walking. Heart disease leading to HF is associated with reduced muscle mass and reduced strength and low blood levels of testosterone; a hormone normally produced by the human (male and female) body. Recent studies have shown improvements of symptoms and ability to exercise in patients with heart failure receiving testosterone.
This is a placebo controlled study to determine the efficacy and safety of low dose testosterone (300 and 450 microgram/day) delivered by a transdermal system (patch) in women with significant HF.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | placebo patch |
|
| 300 µg/day testosterone | Experimental | 300 micrograms/day transdermal testosterone patch |
|
| 450 µg/day testosterone | Experimental | 450 micrograms/day transdermal testosterone patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| placebo | Drug | placebo patch |
| |
| testosterone |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters | Measurement of distance walked as fast as possible on a hard flat pathway in six minutes | Baseline and Day 180 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification | Class I: Cardiac disease w/o limitation of physical activity. Class II: Cardiac disease resulting in slight limitation of physical activity. Comfortable at rest; ordinary activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Cardiac disease resulting in marked limitation of physical activity. Comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. Class IV: Cardiac disease resulting in inability to carry on any physical activity w/o discomfort. Symptoms present at rest. Any physical activity increases discomfort. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose Brum, MD | Procter and Gamble | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85253 | United States | ||
| Research Site |
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6 month trial, screening started 22 Sep 2009 and ended 24 Mar 2010.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | placebo patch |
| FG001 | 300 µg/Day Testosterone | 300 micrograms/day transdermal testosterone patch |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
300 or 450 micrograms/day transdermal testosterone patch |
|
| Baseline and Day 180 |
| Mortality or Hospitalizations | Composite endpoint - patients who were hospitalized or died during the trial. | Baseline and Day 180 |
| Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores | Minnesota Living with Heart Failure Questionnaire assessing how much heart failure affects life during previous month. Three scales measuring physical dimension (8 items, score 0-40), emotional dimension (5 items, score 0-25) and overall score (all 21 items, score 0-105). Eight separate items measure social & economic impairments included as part of overall score. | Baseline and Day 180 |
| Percent Change Patient Global Assessment of Heart Failure Status | Four global questions classifying improvement or deterioration in heart failure - Since your last clinic vist, has there been any change in activity limitation / symptoms / emotions / overall quality of life, related to your heart failure? Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better. | Baseline and Day 180 |
| Percent Change Physician Global Assessment of Heart Failure Status | Physician rates improvement or deterioration in heart failure: Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better. | Baseline and Day 180 |
| Tucson |
| Arizona |
| 85710 |
| United States |
| Research Site | Lakewood | California | 90712 | United States |
| Research Site | Riverside | California | 92501 | United States |
| Research Site | Stamford | Connecticut | 06851 | United States |
| Research Site | Melbourne | Florida | 32901 | United States |
| Research Site | Pensacola | Florida | 32514 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Munster | Indiana | 46321 | United States |
| Research Site | Brooklyn | New York | 11234 | United States |
| Research Site | Wilmington | North Carolina | 28403 | United States |
| Research Site | Greer | South Carolina | 29651 | United States |
| Research Site | Chattanooga | Tennessee | 37421 | United States |
| Research Site | Germantown | Tennessee | 38138 | United States |
| Research Site | San Antonio | Texas | 78229 | United States |
| Research Site | Tacoma | Washington | 98405 | United States |
| FG002 |
| 450 µg/Day Testosterone |
450 micrograms/day transdermal testosterone patch |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | placebo patch |
| BG001 | 300 µg/Day Testosterone | 300 micrograms/day transdermal testosterone patch |
| BG002 | 450 µg/Day Testosterone | 450 micrograms/day transdermal testosterone patch |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters | Measurement of distance walked as fast as possible on a hard flat pathway in six minutes | No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Day 180 |
|
| ||||||||||||||||||||||
| Secondary | Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification | Class I: Cardiac disease w/o limitation of physical activity. Class II: Cardiac disease resulting in slight limitation of physical activity. Comfortable at rest; ordinary activity results in fatigue, palpitation, dyspnea or anginal pain. Class III: Cardiac disease resulting in marked limitation of physical activity. Comfortable at rest; less than ordinary activity causes fatigue, palpitation, dyspnea or anginal pain. Class IV: Cardiac disease resulting in inability to carry on any physical activity w/o discomfort. Symptoms present at rest. Any physical activity increases discomfort. | No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim. | Posted | Number | Percent Change | Baseline and Day 180 |
| ||||||||||||||||||||||||
| Secondary | Mortality or Hospitalizations | Composite endpoint - patients who were hospitalized or died during the trial. | No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim. | Posted | Number | Participants | Baseline and Day 180 |
|
| |||||||||||||||||||||||
| Secondary | Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores | Minnesota Living with Heart Failure Questionnaire assessing how much heart failure affects life during previous month. Three scales measuring physical dimension (8 items, score 0-40), emotional dimension (5 items, score 0-25) and overall score (all 21 items, score 0-105). Eight separate items measure social & economic impairments included as part of overall score. | No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Day 180 |
| |||||||||||||||||||||||
| Secondary | Percent Change Patient Global Assessment of Heart Failure Status | Four global questions classifying improvement or deterioration in heart failure - Since your last clinic vist, has there been any change in activity limitation / symptoms / emotions / overall quality of life, related to your heart failure? Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better. | No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Day 180 |
| |||||||||||||||||||||||
| Secondary | Percent Change Physician Global Assessment of Heart Failure Status | Physician rates improvement or deterioration in heart failure: Scale -7/very great deal worse, -6 great deal worse, -5 good deal worse, -4 moderately worse, -3 somewhat worse, -2 a little worse, -1 hardly any worse/almost the same, 0 no change, 1 hardly better/almost the same, 2 little better, 3 somewhat better, 4 moderately better, 5 good deal better, 6 great deal better, 7 very great deal better. | No statistical analysis performed due to early termination of the study. Study was stopped prior to any subjects reaching a timepoint for efficacy assessment. Safety results were available and recorded in the interim. | Posted | Least Squares Mean | 95% Confidence Interval | Percent Change | Baseline and Day 180 |
|
Six-month treatment period.
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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 | Placebo | placebo patch | 2 | 6 | 4 | 6 | ||
| EG001 | 300 µg/Day Testosterone | 300 micrograms/day transdermal testosterone patch | 0 | 4 | 2 | 4 | ||
| EG002 | 450 µg/Day Testosterone | 450 micrograms/day transdermal testosterone patch | 2 | 7 | 4 | 7 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis Viral | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Application Site Reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema Peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Rhinitis Allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sinus Congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardiac Failure Congestive | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myocardial Infarction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hyperparathyroidism | Endocrine disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal Pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fungal Skin Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Tendon Injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Renal Failure | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Breast Mass | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hirsutism | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grexan Wulff, Manager Regulatory Affairs | Warner Chilcott | 973-442-3376 | gwulff@wcrx.com |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013739 | Testosterone |
| ID | Term |
|---|---|
| D000737 | Androstenols |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | 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 |
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| Male |
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