Back to resultsAssessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure (CORDELIA)
Primary Purpose
Heart Failure
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
placebo
testosterone
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility Criteria
Inclusion Criteria:
- Female 50 years of age or older; post-menopausal (≥ 12 Mo/ from last menstruation)
- Documented left ventricular ejection fraction (LVEF) of 20-40% within 90 days prior to the baseline visit
- History of HF for more than 90 days and a diagnosis of symptomatic HF (Class III NYHA) for at least 30 days prior to the baseline visit
- Ambulatory (i.e., able to walk without assistance of another person or device such as cane or walker)
Exclusion Criteria:
- Neuromuscular or rheumatologic conditions that limit the to their ability to improve walking distance
- Pulmonary edema or multiorgan failure or cardiogenic shock within 30 days prior to the baseline visit
- Congenital heart disease, infiltrative myocardial disease
- Unstable angina or myocardial infarction within 30 days prior to the baseline visit
- Undiagnosed abnormal genital bleeding
- History of breast cancer, breast surgery, or breast disease contraindicating estrogen/hormone therapy
- Polycystic ovary syndrome or any other condition known to be adversely affected by testosterone treatment
- Resting heart rate > 120 bpm
- Systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg
- Known or suspected hypersensitivity or allergy to any adhesive or to any of the components of the testosterone transdermal system (TTS)
- Use of SERMS, SARMS, SPRMs, tibolone, testosterone, estrogen, progesterone agonists and antagonists or taking any prescription and over the counter medications/ nutraceuticals (eg, phyto-estrogens) that may have anabolic or steroid hormonal effects within 30 days prior to the baseline visit
- Use of marketed or investigational oral, sub-lingual, topical, transdermal injectable, or vaginal androgen therapy including dehydroepiandrosterone (DHEA) at any time within 3 months prior to the baseline visit
- Use of systemic corticosteroids within 30 days prior to the baseline visit (acute use for fewer than 7 days is acceptable)
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
placebo
300 µg/day testosterone
450 µg/day testosterone
Arm Description
placebo patch
300 micrograms/day transdermal testosterone patch
450 micrograms/day transdermal testosterone patch
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
Mortality or Hospitalizations
Composite endpoint - patients who were hospitalized or died during the trial.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00957034
Brief Title
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
Acronym
CORDELIA
Official Title
A Placebo-controlled Study to Determine the Efficacy and Safety of 300 and 450 µg/Day Transdermal Testosterone in Female Patients With Low Ejection Fraction and Symptomatic Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Terminated
Why Stopped
Due to difficult patient enrollment.
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo patch
Arm Title
300 µg/day testosterone
Arm Type
Experimental
Arm Description
300 micrograms/day transdermal testosterone patch
Arm Title
450 µg/day testosterone
Arm Type
Experimental
Arm Description
450 micrograms/day transdermal testosterone patch
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo patch
Intervention Type
Drug
Intervention Name(s)
testosterone
Intervention Description
300 or 450 micrograms/day transdermal testosterone patch
Primary Outcome Measure Information:
Title
Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters
Description
Measurement of distance walked as fast as possible on a hard flat pathway in six minutes
Time Frame
Baseline and Day 180
Secondary Outcome Measure Information:
Title
Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification
Description
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.
Time Frame
Baseline and Day 180
Title
Mortality or Hospitalizations
Description
Composite endpoint - patients who were hospitalized or died during the trial.
Time Frame
Baseline and Day 180
Title
Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores
Description
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.
Time Frame
Baseline and Day 180
Title
Percent Change Patient Global Assessment of Heart Failure Status
Description
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.
Time Frame
Baseline and Day 180
Title
Percent Change Physician Global Assessment of Heart Failure Status
Description
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.
Time Frame
Baseline and Day 180
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Female 50 years of age or older; post-menopausal (≥ 12 Mo/ from last menstruation)
Documented left ventricular ejection fraction (LVEF) of 20-40% within 90 days prior to the baseline visit
History of HF for more than 90 days and a diagnosis of symptomatic HF (Class III NYHA) for at least 30 days prior to the baseline visit
Ambulatory (i.e., able to walk without assistance of another person or device such as cane or walker)
Exclusion Criteria:
Neuromuscular or rheumatologic conditions that limit the to their ability to improve walking distance
Pulmonary edema or multiorgan failure or cardiogenic shock within 30 days prior to the baseline visit
Congenital heart disease, infiltrative myocardial disease
Unstable angina or myocardial infarction within 30 days prior to the baseline visit
Undiagnosed abnormal genital bleeding
History of breast cancer, breast surgery, or breast disease contraindicating estrogen/hormone therapy
Polycystic ovary syndrome or any other condition known to be adversely affected by testosterone treatment
Resting heart rate > 120 bpm
Systolic blood pressure > 180 mmHg or diastolic blood pressure > 100 mmHg
Known or suspected hypersensitivity or allergy to any adhesive or to any of the components of the testosterone transdermal system (TTS)
Use of SERMS, SARMS, SPRMs, tibolone, testosterone, estrogen, progesterone agonists and antagonists or taking any prescription and over the counter medications/ nutraceuticals (eg, phyto-estrogens) that may have anabolic or steroid hormonal effects within 30 days prior to the baseline visit
Use of marketed or investigational oral, sub-lingual, topical, transdermal injectable, or vaginal androgen therapy including dehydroepiandrosterone (DHEA) at any time within 3 months prior to the baseline visit
Use of systemic corticosteroids within 30 days prior to the baseline visit (acute use for fewer than 7 days is acceptable)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Brum, MD
Organizational Affiliation
Procter and Gamble
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85253
Country
United States
Facility Name
Research Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Research Site
City
Lakewood
State/Province
California
ZIP/Postal Code
90712
Country
United States
Facility Name
Research Site
City
Riverside
State/Province
California
ZIP/Postal Code
92501
Country
United States
Facility Name
Research Site
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06851
Country
United States
Facility Name
Research Site
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
Country
United States
Facility Name
Research Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32514
Country
United States
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Research Site
City
Munster
State/Province
Indiana
ZIP/Postal Code
46321
Country
United States
Facility Name
Research Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11234
Country
United States
Facility Name
Research Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28403
Country
United States
Facility Name
Research Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Research Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Research Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Research Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Research Site
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
12. IPD Sharing Statement
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Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
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