A Return of Spontaneous Erections in Men with Erectile Dysfunction Noted in Important New Study With CAVERJECT(R)

Apr 12, 2001, 01:00 ET from University of Western Ontario, St. Joseph's Health Care

    LONDON, Ontario, April 12 /PRNewswire/ -- A clinical trial in men with a
 history of erectile dysfunction showed a return of spontaneous erections in
 85 percent of the men using CAVERJECT(R) (alprostadil for injection) over a
 12-month period, a significant improvement from a baseline of 37 percent. The
 study was published in the March issue of Urology, (57:536-541, 2001); a
 peer-reviewed journal read by urologists and sexual health specialists
 worldwide.
     The study specifically looked at the flow of blood into the arteries of
 the penis. Blood flow through the cavernosal arteries engorges the penis,
 creating an erection suitable for sexual intercourse. CAVERJECT works by
 relaxing the smooth muscle of the penis and the muscles surrounding the
 arteries, allowing for an increase in blood flow to the penis.
     "A significant number of men in this study experienced a measurable
 improvement in blood flow, one of the most common physical contributors to
 erectile dysfunction," said Gerald Brock, MD, associate professor, Department
 of Urology, at the University of Western Ontario, St. Joseph's Health Care,
 London, and lead study investigator. "A significant number of men also
 reported an increase in return of spontaneous erections. Both of these results
 offer particularly encouraging news for the many millions of men worldwide
 that suffer regularly from erectile dysfunction," he added.
     Erectile dysfunction is characterized by the inability to achieve or
 maintain an erect penis sufficient for sexual intercourse. The inability to
 maintain an erection can be caused by physical (e.g., diabetes, heart disease
 and high blood pressure) or situational conditions that work alone or in
 combination to inhibit a successful erection. The vast majority of cases have
 been found to be treatable.
     The open-label study involved 70 men, ages 18 and older with documented
 arteriogenic ED of at least four months who had not previously been treated
 for this condition. The study measured improvements in penile circulation and
 reported the reoccurrence of spontaneous erections experienced at four, eight
 and 12-months from baseline with regular use of CAVERJECT. The minimal dose
 necessary to obtain an erection suitable for intercourse was first determined
 in a clinical setting, followed by an in-home period during which study
 participants were instructed to administer CAVERJECT by injection two to three
 times a week. Diaries were completed in which the duration and overall quality
 of the erection and subsequent sexual activity was recorded. Of the 70 men
 entering the study, 63 men entered the home maintenance phase and 42 completed
 the 12-month treatment phase.
     During twelve months, 85 percent of the men (46 of 54) reported
 experiencing spontaneous erections, a significant improvement from a baseline
 of 37 percent, with 74 percent of these episodes resulting in satisfactory
 intercourse as reported by the men and their partners. Penile circulation was
 significantly improved at four and eight months and still noted at 12 months
 based on duplex ultrasound data in 38 men.
     Adverse events after administration of CAVERJECT were generally regarded
 as tolerable, with temporary penile or injection site pain the most reported
 side effect in 23 percent of men in the trial, and six percent reported
 prolonged erection (spontaneously resolved).
     "These results should also be of special interest for men who have
 difficulty obtaining desired results with current oral therapies for erectile
 dysfunction, or those who can not take oral medications due to a pre-existing
 condition," said Dr. Brock. "The administration of CAVERJECT in this study
 yielded a significant increase in spontaneous erections and should be taken
 into consideration by physicians in the long-term treatment plan for their
 erectile dysfunction patients."
     Urology is an important program of St. Joseph's Health Care, a major
 patient care and teaching and research center located in London, Ontario,
 Canada.
     CAVERJECT is a self-injection medication indicated for the treatment of
 erectile dysfunction due to neurologic, vasculogenic, psychogenic, or mixed
 etiology. CAVERJECT is also indicated as an adjunct to other diagnostic tests
 in the diagnosis of erectile dysfunction.
     CAVERJECT is generally well tolerated. The most common side effect is mild
 to moderate penile pain that occurs in about a third of men. CAVERJECT should
 not be used in men who have conditions that might predispose them to priapism
 (erections lasting longer than six hours that can cause permanent tissue
 damage if untreated), or in men with anatomical deformation of the penis or
 penile implants.
 
 

SOURCE University of Western Ontario, St. Joseph's Health Care
    LONDON, Ontario, April 12 /PRNewswire/ -- A clinical trial in men with a
 history of erectile dysfunction showed a return of spontaneous erections in
 85 percent of the men using CAVERJECT(R) (alprostadil for injection) over a
 12-month period, a significant improvement from a baseline of 37 percent. The
 study was published in the March issue of Urology, (57:536-541, 2001); a
 peer-reviewed journal read by urologists and sexual health specialists
 worldwide.
     The study specifically looked at the flow of blood into the arteries of
 the penis. Blood flow through the cavernosal arteries engorges the penis,
 creating an erection suitable for sexual intercourse. CAVERJECT works by
 relaxing the smooth muscle of the penis and the muscles surrounding the
 arteries, allowing for an increase in blood flow to the penis.
     "A significant number of men in this study experienced a measurable
 improvement in blood flow, one of the most common physical contributors to
 erectile dysfunction," said Gerald Brock, MD, associate professor, Department
 of Urology, at the University of Western Ontario, St. Joseph's Health Care,
 London, and lead study investigator. "A significant number of men also
 reported an increase in return of spontaneous erections. Both of these results
 offer particularly encouraging news for the many millions of men worldwide
 that suffer regularly from erectile dysfunction," he added.
     Erectile dysfunction is characterized by the inability to achieve or
 maintain an erect penis sufficient for sexual intercourse. The inability to
 maintain an erection can be caused by physical (e.g., diabetes, heart disease
 and high blood pressure) or situational conditions that work alone or in
 combination to inhibit a successful erection. The vast majority of cases have
 been found to be treatable.
     The open-label study involved 70 men, ages 18 and older with documented
 arteriogenic ED of at least four months who had not previously been treated
 for this condition. The study measured improvements in penile circulation and
 reported the reoccurrence of spontaneous erections experienced at four, eight
 and 12-months from baseline with regular use of CAVERJECT. The minimal dose
 necessary to obtain an erection suitable for intercourse was first determined
 in a clinical setting, followed by an in-home period during which study
 participants were instructed to administer CAVERJECT by injection two to three
 times a week. Diaries were completed in which the duration and overall quality
 of the erection and subsequent sexual activity was recorded. Of the 70 men
 entering the study, 63 men entered the home maintenance phase and 42 completed
 the 12-month treatment phase.
     During twelve months, 85 percent of the men (46 of 54) reported
 experiencing spontaneous erections, a significant improvement from a baseline
 of 37 percent, with 74 percent of these episodes resulting in satisfactory
 intercourse as reported by the men and their partners. Penile circulation was
 significantly improved at four and eight months and still noted at 12 months
 based on duplex ultrasound data in 38 men.
     Adverse events after administration of CAVERJECT were generally regarded
 as tolerable, with temporary penile or injection site pain the most reported
 side effect in 23 percent of men in the trial, and six percent reported
 prolonged erection (spontaneously resolved).
     "These results should also be of special interest for men who have
 difficulty obtaining desired results with current oral therapies for erectile
 dysfunction, or those who can not take oral medications due to a pre-existing
 condition," said Dr. Brock. "The administration of CAVERJECT in this study
 yielded a significant increase in spontaneous erections and should be taken
 into consideration by physicians in the long-term treatment plan for their
 erectile dysfunction patients."
     Urology is an important program of St. Joseph's Health Care, a major
 patient care and teaching and research center located in London, Ontario,
 Canada.
     CAVERJECT is a self-injection medication indicated for the treatment of
 erectile dysfunction due to neurologic, vasculogenic, psychogenic, or mixed
 etiology. CAVERJECT is also indicated as an adjunct to other diagnostic tests
 in the diagnosis of erectile dysfunction.
     CAVERJECT is generally well tolerated. The most common side effect is mild
 to moderate penile pain that occurs in about a third of men. CAVERJECT should
 not be used in men who have conditions that might predispose them to priapism
 (erections lasting longer than six hours that can cause permanent tissue
 damage if untreated), or in men with anatomical deformation of the penis or
 penile implants.
 
 SOURCE  University of Western Ontario, St. Joseph's Health Care