Clinical trial NCT00957034: Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Heart Failure
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 17
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Percent Change From Baseline in Six Minute Walking Test (6MWT), Meters
timeFrame: Baseline and Day 180
Secondary outcomes:
measure: Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification
timeFrame: Baseline and Day 180
measure: Mortality or Hospitalizations
timeFrame: Baseline and Day 180
measure: Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores
timeFrame: Baseline and Day 180
measure: Percent Change Patient Global Assessment of Heart Failure Status
timeFrame: Baseline and Day 180
measure: Percent Change Physician Global Assessment of Heart Failure Status
timeFrame: Baseline and Day 180
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Lakewood
country: United States
facility: Research Site
state: California
city: Riverside
country: United States
facility: Research Site
state: California
city: Stamford
country: United States
facility: Research Site
state: Connecticut
city: Melbourne
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Savannah
country: United States
facility: Research Site
state: Georgia
city: Munster
country: United States
facility: Research Site
state: Indiana
city: Brooklyn
country: United States
facility: Research Site
state: New York
city: Wilmington
country: United States
facility: Research Site
state: North Carolina
city: Greer
country: United States
facility: Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Research Site
state: Tennessee
city: Germantown
country: United States
facility: Research Site
state: Tennessee
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Tacoma
country: United States
facility: Research Site
state: Washington
Study officials:
affiliation: Procter and Gamble
name: Jose Brum, MD
role: STUDY_DIRECTOR
References: