Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure (CORDELIA)

This study has been terminated.
(Due to difficult patient enrollment.)
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00957034
First received: August 10, 2009
Last updated: December 6, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Heart Failure
Drug: placebo
Drug: testosterone
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline and Day 180 ] [ Designated as safety issue: No ]
    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.


Enrollment: 17
Study Start Date: July 2009
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
placebo patch
Drug: placebo
placebo patch
Experimental: 300 µg/day testosterone
300 micrograms/day transdermal testosterone patch
Drug: testosterone
300 or 450 micrograms/day transdermal testosterone patch
Experimental: 450 µg/day testosterone
450 micrograms/day transdermal testosterone patch
Drug: testosterone
300 or 450 micrograms/day transdermal testosterone patch

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00957034

Locations
United States, Arizona
Research Site
Phoenix, Arizona, United States, 85253
Research Site
Tucson, Arizona, United States, 85710
United States, California
Research Site
Lakewood, California, United States, 90712
Research Site
Riverside, California, United States, 92501
United States, Connecticut
Research Site
Stamford, Connecticut, United States, 06851
United States, Florida
Research Site
Melbourne, Florida, United States, 32901
Research Site
Pensacola, Florida, United States, 32514
United States, Georgia
Research Site
Savannah, Georgia, United States, 31406
United States, Indiana
Research Site
Munster, Indiana, United States, 46321
United States, New York
Research Site
Brooklyn, New York, United States, 11234
United States, North Carolina
Research Site
Wilmington, North Carolina, United States, 28403
United States, South Carolina
Research Site
Greer, South Carolina, United States, 29651
United States, Tennessee
Research Site
Chattanooga, Tennessee, United States, 37421
Research Site
Germantown, Tennessee, United States, 38138
United States, Texas
Research Site
San Antonio, Texas, United States, 78229
United States, Washington
Research Site
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Jose Brum, MD Procter and Gamble
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00957034     History of Changes
Other Study ID Numbers: 2009015
Study First Received: August 10, 2009
Results First Received: August 3, 2011
Last Updated: December 6, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Anabolic Agents

ClinicalTrials.gov processed this record on July 20, 2014