NCT00957034

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for phase_2 heart-failure

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2 heart-failure

Geographic Reach
1 country

16 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 10, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 12, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

January 13, 2012

Completed
Last Updated

January 13, 2012

Status Verified

November 1, 2011

Enrollment Period

9 months

First QC Date

August 10, 2009

Results QC Date

August 3, 2011

Last Update Submit

December 6, 2011

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (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

    Baseline and Day 180

Secondary Outcomes (5)

  • Percent Change From Baseline in Severity of Heart Failure (HF) as Measured by New York Heart Association (NYHA) Classification

    Baseline and Day 180

  • Mortality or Hospitalizations

    Baseline and Day 180

  • Percent Change Minnesota Living With Heart Failure Questionnaire (MLHFQ) Overall Score and Domain Scores

    Baseline and Day 180

  • Percent Change Patient Global Assessment of Heart Failure Status

    Baseline and Day 180

  • Percent Change Physician Global Assessment of Heart Failure Status

    Baseline and Day 180

Study Arms (3)

placebo

PLACEBO COMPARATOR

placebo patch

Drug: placebo

300 µg/day testosterone

EXPERIMENTAL

300 micrograms/day transdermal testosterone patch

Drug: testosterone

450 µg/day testosterone

EXPERIMENTAL

450 micrograms/day transdermal testosterone patch

Drug: testosterone

Interventions

placeboDRUG

placebo patch

placebo
testosteroneDRUG

300 or 450 micrograms/day transdermal testosterone patch

300 µg/day testosterone450 µg/day testosterone

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

Research Site

Phoenix, Arizona, 85253, United States

Location

Research Site

Tucson, Arizona, 85710, United States

Location

Research Site

Lakewood, California, 90712, United States

Location

Research Site

Riverside, California, 92501, United States

Location

Research Site

Stamford, Connecticut, 06851, United States

Location

Research Site

Melbourne, Florida, 32901, United States

Location

Research Site

Pensacola, Florida, 32514, United States

Location

Research Site

Savannah, Georgia, 31406, United States

Location

Research Site

Munster, Indiana, 46321, United States

Location

Research Site

Brooklyn, New York, 11234, United States

Location

Research Site

Wilmington, North Carolina, 28403, United States

Location

Research Site

Greer, South Carolina, 29651, United States

Location

Research Site

Chattanooga, Tennessee, 37421, United States

Location

Research Site

Germantown, Tennessee, 38138, United States

Location

Research Site

San Antonio, Texas, 78229, United States

Location

Research Site

Tacoma, Washington, 98405, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Testosterone

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AndrostenolsAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsTestosterone CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Grexan Wulff, Manager Regulatory Affairs
Organization
Warner Chilcott
gwulff@wcrx.com
973-442-3376

Study Officials

  • Jose Brum, MD

    Procter and Gamble

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 10, 2009

First Posted

August 12, 2009

Study Start

July 1, 2009

Primary Completion

April 1, 2010

Study Completion

May 1, 2010

Last Updated

January 13, 2012

Results First Posted

January 13, 2012

Record last verified: 2011-11

Locations

US(16)