Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Rare Diseases

Neoplasm Metastasis

Sclerosis

Scleroderma, Systemic

Scleroderma, Diffuse

Raynaud Disease

Neoplastic Processes

Connective Tissue Diseases

Skin Diseases

Vascular Diseases

Livedoid Vasculopathy

Thrombosis

Embolism

Embolism and Thrombosis

Peripheral Arterial Disease

Peripheral Vascular Diseases

Skin Diseases, Vascular

Systemic Scleroderma

Acute Graft Versus Host Disease

Vasodilator Agents

Platelet Aggregation Inhibitors

Urological Agents

All Drugs and Chemicals

Alprostadil

300 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

1000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

3000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, two dispensers for each administration

Placebo

Barbara Troupin, MD, MBA

The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).

The purpose of this study is to evaluate the pharmacodynamic (PD) effects of topical Alprostadil on digital perfusion by laser Doppler capillary velocimetry and digital temperature recovery with thermography following standardized cold challenge and to assess the safety and tolerability of 3 doses of Alprostadil topical cream and placebo cream in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).

Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)

NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Behaviors and Mental Disorders

Prostatic Neoplasms

Erectile Dysfunction

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Sexual Dysfunction, Physiological

Sexual Dysfunctions, Psychological

Mental Disorders

Psychotic Disorders

Anticoagulants

Other Dietary Supplements

Citric Acid

Sodium Citrate

Sildenafil Citrate

Phosphodiesterase 5 Inhibitors

Phosphodiesterase Inhibitors

Enzyme Inhibitors

Citrate

Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate

alprostadil

robotic-assisted laparoscopic surgery

quality-of-life assessment

questionnaire administration

Laura Crocitto

RATIONALE: Sildenafil citrate and alprostadil may help patients who have undergone prostatectomy for prostate cancer to recover from erectile dysfunction.

PURPOSE: This randomized clinical trial is studying giving sildenafil together with alprostadil in treating patients undergoing nerve-sparing robotic-assisted radical prostatectomy for nonmetastatic prostate cancer.

PRIMARY OBJECTIVES:

I. To determine the rate of erectile function (defined as the ability to achieve and maintain an erection sufficient for intercourse without the use of pharmacological assistance) at 1 year post-operatively in men undergoing BNS-RAP without the use of post-operative maintenance pharmacotherapy.

II. To describe whether early post-operative maintenance pharmacotherapy Viagra can improve return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.

III. To describe if early post-operative maintenance pharmacotherapy Viagra can decrease the time-to-return of erectile function in patients undergoing BNS-RAP.

SECONDARY OBJECTIVES:

I. To describe whether early post-operative maintenance pharmacotherapy MUSE can improve return of erectile function at 1 year post-operatively in patients undergoing BNS-RAP.

II. To describe if early post-operative maintenance pharmacotherapy MUSE can decrease the time-to-return of erectile function in patients undergoing BNS-RAP.

III. To compare sexual function quality of life in men undergoing early post-operative maintenance pharmacotherapy to those without early post-operative maintenance pharmacotherapy.

IV. To compare the rate of potency at 1, 3, 6, 9, 12, and 18 months in men using Viagra versus MUSE for early post-operative maintenance pharmacotherapy.

V. To describe the dropout rate for MUSE maintenance pharmacotherapy secondary to urethral pain in men using 2% Lidocaine lubricant.

VI. To describe if penile length is decreased following BNS-RAP. VII. To describe if penile length at one year is different in men who have return of potency versus those with no return of potency.

OUTLINE: Patients receive 2 doses of intraurethral alprostadil prior to undergoing bilateral nerve-sparing robotic-assisted prostatectomy. Within 4 weeks after surgery, patients are randomized to 1 of 3 treatment arms.

ARM I: Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.

ARM II: Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months.

ARM III: Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months.

After completion of study treatment, patients are followed periodically for up to 18 months.

ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer

Erectile Dysfunction Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy (BNS-RAP) for Prostate Cancer

Potency rates (ability to obtain an erection sufficient for penetration) without assistance in those patients receiving maintenance Viagra compared to non-pharmacology controls was compared at 12 months from start of treatment using the fisher's exact test

Potency rates with or without assistance in the control group versus maintenance MUSE or maintenance Viagra were compared at each of 6 and 18 months

Median and range of SHIM scores evaluated at 1, 3, 6, 9, 12, and 18 months. SHIMS-5 is the Sexual Health Inventory for Men, which includes 5 questions that are scored from 1 to 5 each. The total score is obtained by adding all five response scores, and can range from 5 to 25 when all 5 questions are answered. Questions that are left unanswered are scored as a 0, and can result in an overall score lower than 5 (as low as 0). Higher scores are more desirable. A Score of 22-25 = no ED, 17-21=Mild ED, 12-16=Mild to moderate ED, 8-11=Moderate ED, and 5-7 =Severe ED (ED=Erectile Dysfunction). There are no sub-scale scores within this questionnaire.

measurement of penile length in centimeters

City of Hope Medical Center

The drugs that were tested on patients on the three arms are all FDA-approved drugs and were prescribed/provided in doses that were FDA-approved.

Patients receive intraurethral alprostadil once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

alprostadil: Given intraurethrally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

Sildenafil Citrate/Mo+Aprostadil/Day

Patients receive 3 doses of oral sildenafil citrate on 3 separate occasions at least 48 hours apart monthly for 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

Sildenafil Citrate Monthly

Patients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

Daily Sildenafil Citrate

Sildenafil Citrate Monthly Daily Sildenafil Citrate

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

In addition to the fact that the trial was closed mid-way through accrual, nearly half of those that accrued dropped out prior to completing treatment. There is not enough power to make any conclusions regarding any of the aims set forth.

Laura Crocitto, M.D.

These are the patients who remained on treatment for the duration of the 12 months and were evaluable at that time point.

Potency Rates (Ability to Obtain an Erection Sufficient for Penetration) Without Assistance Compared Between Patients in All Three Arms of the Study at 12 Months

compare percentage of patients potent at 6 and 18 months across pairs of treatment arms (arm I vs arm II, arm I vs arm III, arm II vs arm III)

6 month potency

18 month potency

P atients receive oral sildenafil citrate once daily for up to 9 months in the absence of disease progression or unacceptable toxicity. Patients also receive 3 doses of oral sildenafil citrate at least 48 hours apart monthly for up to 18 months. Patients on all three arms will have undergone robotic-assisted laparoscopic surgery. All patients will take part in the questionnaire administration and quality-of-life assessments.

sildenafil citrate: Given orally

robotic-assisted laparoscopic surgery: Undergo prostatectomy

quality-of-life assessment: Ancillary studies

questionnaire administration: Ancillary studies

patients who were evaluated at 6 months, 18 months

Potency Rates With or Without Assistance in the Control Group Versus Maintenance MUSE or Maintenance Viagra

SHIM score 1 month

SHIM score 3 months

SHIM score 6 months

SHIM score 9 months

SHIM score 12 months

SHIM score 18 months

SHIMS-5 Scores in the Control Groups Versus Maintenance MUSE or Maintenance Viagra Groups

ANOVA test to compare difference of penile length (from baseline to month 18) across arms.

calculations are underpowered, as study did not accrue or retain patients as intended, and many patients declined to have measurements taken.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
ED Recovery in Men Age </=65 Treated With Bilateral Nerve Sparing Robotic Assisted Prostatectomy for Prostate Cancer	NCT00544076	Prostate Cancer Male Erectile D... Stage I Prostat... Stage II Prosta...	sildenafil citr... alprostadil robotic-assiste... quality-of-life... questionnaire a...	18 Years - 65 Years	City of Hope Medical Center
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Spots Global Cancer Trial Database for alprostadil

Every month we try and update this database with for alprostadil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for alprostadil

Every month we try and update this database with for alprostadil cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for alprostadil cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.