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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testosterone Therapy in Heart Failure

NCT01377103

Heart Failure Hypogonadism

WITHDRAWN NA

Effect of Testosterone Replacement on Exercise Capacity in Hypogonadal Men After a Recent Myocardial Infarction

NCT02803073

Hypogonadism Acute Myocardial Infarction: Rehabilitation Phase

WITHDRAWN PHASE2/PHASE3

Testosterone Improves Exercise Oxygen Uptake, Insulin Resistance and Muscle Strength in Elderly Patients With Chronic Heart Failure

NCT00512408

Congestive Heart Failure

TERMINATED

Pharmacokinetics, Metabolism, Efficacy, and Safety Study of Two Testosterone Matrix Transdermal Systems

NCT01323140

Hypogonadism

COMPLETED PHASE2

Benefit of the Treatment With Testosterone in Chronic Heart Failure Testosterone Deficiency Subjects

NCT01813201

Heart Failure

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Heart Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

placebo

placebo patch

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

placebo patch

300 µg/day testosterone

300 micrograms/day transdermal testosterone patch

Group Type EXPERIMENTAL

testosterone

Intervention Type DRUG

300 or 450 micrograms/day transdermal testosterone patch

450 µg/day testosterone

450 micrograms/day transdermal testosterone patch

Group Type EXPERIMENTAL

testosterone

* 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)

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No