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Heart FailurePhase 2CORDELIANCT00957034

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

A Phase 2 study testing testosterone in people with Heart Failure, run by Warner Chilcott at 16 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 50 years and older, women only
Conditions the study is for
Heart Failure
What is being tested?
testosterone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
17 participants
Where
16 sitesUnited States
Study dates
Jul 2009to May 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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
Show all 13Show fewer
  • 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)

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Research Site

    Brooklyn, New York, 11234

  • Research Site

    Chattanooga, Tennessee, 37421

  • Research Site

    Germantown, Tennessee, 38138

  • Research Site

    Greer, South Carolina, 29651

  • Research Site

    Lakewood, California, 90712

  • Research Site

    Melbourne, Florida, 32901

  • Research Site

    Munster, Indiana, 46321

  • Research Site

    Pensacola, Florida, 32514

  • Research Site

    Phoenix, Arizona, 85253

  • Research Site

    Riverside, California, 92501

  • Research Site

    San Antonio, Texas, 78229

  • Research Site

    Savannah, Georgia, 31406

  • Research Site

    Stamford, Connecticut, 06851

  • Research Site

    Tacoma, Washington, 98405

  • Research Site

    Tucson, Arizona, 85710

  • Research Site

    Wilmington, North Carolina, 28403

Other trials in United States

About this study

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

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.

Conditions
Heart Failure
Being tested
placebo, testosterone
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    placebo patch

  • testosteroneDrug

    300 or 450 micrograms/day transdermal testosterone patch

Study groups in NCT00957034
Study groupRoleWhat they receive
placeboPlacebo comparatorplacebo patch
Receives: Drug: placebo
300 µg/day testosteroneExperimental300 micrograms/day transdermal testosterone patch
Receives: Drug: testosterone
450 µg/day testosteroneExperimental450 micrograms/day transdermal testosterone patch
Receives: Drug: testosterone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Baseline and Day 180

Secondary outcomes (5)

  1. 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.

    Measured: Baseline and Day 180

  2. Mortality or Hospitalizations

    Composite endpoint - patients who were hospitalized or died during the trial.

    Measured: Baseline and Day 180

  3. 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.

    Measured: Baseline and Day 180

  4. 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.

    Measured: Baseline and Day 180

  5. 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.

    Measured: Baseline and Day 180

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionApr 2010
  4. Study completionMay 2010

Why it stopped: Due to difficult patient enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00957034
Sponsor's protocol ID
2009015
Acronym
CORDELIA
Status last verified
Nov 2011
First submitted
10 Aug 2009
Last updated
13 Jan 2012
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing testosterone in people with Heart Failure, run by Warner Chilcott at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters (time frame: Baseline and Day 180). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00957034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2012.

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