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NCT00957034 · ClinicalTrials.gov registry record · Phase 2
Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With Symptomatic Heart Failure
A Phase 2 study, sponsored by Warner Chilcott.
- Terminated
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
NCT00957034 is a Phase 2 study that was terminated before completion, run by Warner Chilcott. The registered enrollment target is 17 participants.
The verdict
NCT00957034, a Phase 2 study, was terminated before completion, sponsored by Warner Chilcott.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
Study 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.
Interventions
- DRUG placebo
- DRUG testosterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2009-07 |
| Est. Completion | 2010-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00957034
The ClinicalTrials.gov registry entry for NCT00957034 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Warner Chilcott, which has 53 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00957034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00957034 about?
NCT00957034 is a clinical study titled "Assessing the Safety/Efficacy of Transdermal Testosterone in Female Patients With 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 ph...
What is the current status of trial NCT00957034?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2009-07. Estimated completion is 2010-05.
What interventions are being tested in trial NCT00957034?
The interventions under investigation include: placebo (DRUG), testosterone (DRUG).
Who is sponsoring clinical trial NCT00957034?
This trial is sponsored by Warner Chilcott, which has 53 total clinical trials registered on ClinicalTrials.gov.
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