Atorvastatin for Erectile Dysfunction

Phase-Based Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Erectile Dysfunction+3 More
Atorvastatin - Drug
Eligibility
18+
Male
Eligible conditions
Erectile Dysfunction

Study Summary

This study is evaluating whether a combination of drugs may help improve erectile dysfunction in prostate cancer patients.

See full description

Eligible Conditions

  • Erectile Dysfunction
  • Erectile Dysfunction, CTCAE
  • sexual impotency
  • Adenocarcinoma, Prostate

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Atorvastatin will improve 1 primary outcome, 2 secondary outcomes, and 1 other outcome in patients with Erectile Dysfunction. Measurement will happen over the course of Baseline.

Baseline
Baseline patient features
Month 12
Change in International Index of Erectile Function (IIEF) scores
Up to 12 months
Incidence of adverse events (AEs)
Rate of choosing other ED treatments after PAVE

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

2 Treatment Groups

Control
Treatment (atorvastatin, vitamin E, pentoxifylline)

This trial requires 270 total participants across 2 different treatment groups

This trial involves 2 different treatments. Atorvastatin is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (atorvastatin, vitamin E, pentoxifylline)Patients receive atorvastatin PO QD for up to 6 weeks in the absence of disease progression or unacceptable toxicity. Beginning week 7, patients receive atorvastatin PO QD, vitamin E PO QD, and pentoxifylline PO TID for up to 12 months in the absence of disease progression or unacceptable toxicity.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pentoxifylline
FDA approved
Atorvastatin
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 12 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 12 months for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for male patients aged 18 and older. There are 8 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Normal testosterone (including men on testosterone replacement), defined as testosterone > 150 ng/dl at the time of screening
Karnofsky Performance Status (KPS) >= 70, or Eastern Cooperative Oncology Group (ECOG) 0-2
Patients may be taking an HMG-coA-reductase inhibitor Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =< 3 X upper limits of normal (ULN)
Normal renal function is defined as creatinine clearance >= 30 ml/min via the Cockcroft Gault formula
Histologically or cytologically confirmed diagnosis of adenocarcinoma of the prostate
Previous radiation therapy (any form) with curative intent for prostate cancer
Erectile dysfunction, as determined by an International Index of Erectile Function (IIEF)-5 score of < 22
Creatinine kinase < 5 times ULN

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What causes erectile dysfunction?

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The most convincing theory to date for the genesis of erectile dysfunction in humans is 'neurotic erectile dysfunction' caused by anxiety (for a detailed discussion, see 'Theories' by Michael G. Spitzer). One of the factors driving this anxiety is low self-esteem, which can contribute to anxiety and consequently to erectile dysfunction. Stress in the form of marital discord, a serious health problem (high-risk partner), is another key factor that is a key cause of erectile dysfunction in men. It is also important to distinguish the cause of neurotic erectile dysfunction, and that this syndrome can occur in men with an erectile dysfunction cause otherwise unexplained by physical examination.

Unverified Answer

What is erectile dysfunction?

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It is well supported that NO is at least partially involved in the pathophysiology of erectile dysfunction, as measured by the rigid penile plethysmograph. NO is undoubtedly involved in the pathophysiology of erectile dysfunction, because endothelial dysfunction, mediated by NO, was shown to contribute to reduced penile blood flow during erection. Reduced penile blood flow enhances endothelial dysfunction, whereas increased penile blood flow enhances endothelium-dependent relaxation. Erectile dysfunction may therefore be improved by reversing endothelial dysfunction. Nitroglycerin may represent a treatment for patients suffering from erectile dysfunction. Moreover, nitroglycerin in the right dosage improves penile blood flow during orgasm.

Unverified Answer

How many people get erectile dysfunction a year in the United States?

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About 7.5 million men and women are affected by erectile dysfunction in the United States. It is not known if the incidence of ED in men increases for every 1 °C increase in their body temperature.

Unverified Answer

What are the signs of erectile dysfunction?

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The only way to obtain an exact definition is to look at the signs and symptoms found in men with no history or knowledge of penile disease. The presence of penile tumescence during a physical examination indicates venous obstruction—not necessarily the erectile dysfunction. penile tumescence.

Unverified Answer

Can erectile dysfunction be cured?

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A single dose of injectable SDF (a novel and stable, vascular-enhanced local delivery system) can restore erectile function and reduce signs and symptoms of ED without major side-effects in rats with ED. SDF-mediated restoration of vasodilatory function through localized delivery may be effective in men with ED.

Unverified Answer

What are common treatments for erectile dysfunction?

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The most common treatment for erectile dysfunction is sildenafil citrate. Other solutions may include other anti-erectile dysfunction medications such as testosterone. Moreover, nonpharmacological treatments, such as acupuncture, may be considered when other medications such as medications, psychological therapies and surgery are not the solution.

Unverified Answer

Does atorvastatin improve quality of life for those with erectile dysfunction?

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Use of atorvastatin in men with ED was associated with decreased HR-QoL, both in overall and specific HR-QoL. Results from a recent clinical trial indicate that atorvastatin may have potential value as a therapy for ED.

Unverified Answer

Is atorvastatin safe for people?

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There was no difference in lipid or lipid-related parameters, and some patients suffered with significant and unexpected, clinically significant haematuria and associated renal failure. The use of atorvastatin appears to be safe for the general population, but care must be taken in patients with mild renal disease.

Unverified Answer

What is the primary cause of erectile dysfunction?

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The degree of impairment of self-esteem did not seem to influence the degree of impairment in sexual activity of the patient with the primary cause of impotence being of vascular origin. The presence of vascular disease was also not found to be associated with more severe impairment in sexual activity. On the contrary, patients with a primary cause of vascular origin and low/low-moderate satisfaction with health and life appeared to be significantly less willing to consult a doctor about their erectile dysfunction. The present results suggest that vascular disease should be considered as a possible cause of erectile dysfunction that does not necessarily correlate with impaired sexual potency.

Unverified Answer

Have there been other clinical trials involving atorvastatin?

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There is limited evidence to date from other clinical trials supporting long-term use. Given the limited evidence available, caution is necessary before making a recommendation for routine use of atorvastatin. Longer-term studies are necessary with larger patient populations to confirm these findings.

Unverified Answer

Has atorvastatin proven to be more effective than a placebo?

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In comparison with placebo, the drug group showed a significantly greater improvement in symptoms and increased penile erectile velocity, and demonstrated a more significant and sustained response.

Unverified Answer

How does atorvastatin work?

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Atorvastatin has both vascular and non-vascular effects. The vasodilating effects on ED can happen within 8 days of atorvastatin administration. The non-vascular effect of atorvastatin may partly occur when other antioxidants are depleted and vascular endothelial dysfunction may occur in severe statin-induced diabetes mellitus patients.

Unverified Answer
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