NEW YORK (January 30, 2013) -- New data suggests the erectile dysfunction (ED) drug Cialis may also be beneficial in helping men who have problems with ejaculation and orgasm, report researchers from NewYork-Presbyterian Hospital/Weill Cornell Medical Center in the February issue of the British Journal of Urology International. Cialis is currently approved for the treatment of ED, benign prostate hypertrophy (BPH) and for treatment of men with both conditions.
Their study, a meta-analysis of 17 double-blind, placebo-controlled clinical trials of men with ED, is the first to analyze the benefit an agent like Cialis offers for common issues of sexual dysfunction that may have little to do with ED. Their study concluded that approximately 70 percent of men who used Cialis during sexual activity for 12 weeks were able to ejaculate most of the time and to reach orgasm, compared to 30 percent in the placebo group. Also, these benefits from the drug were seen despite the level of a man's ED severity.
"There are many men who have, at most, very mild problems achieving an erection but who cannot easily ejaculate," says the study's lead author, Dr. Darius Paduch, a urologist and male sexual medicine specialist at NewYork-Presbyterian/Weill Cornell and director of Sexual Health and Medicine at Weill Cornell Medical College. "Our study shows Cialis works very well for these men with problems ejaculating."
Dr. Paduch says up to 18 percent of men have a normal erection but don't ejaculate, or take a long time to do so. He adds that while the issue may be more prevalent in the elderly, it affects men of all ages.
"Many of my patients are young men who want to have children and so they want to solve their issues with ejaculation," says Dr. Paduch, who is also an associate professor of urology and reproductive medicine at Weill Cornell. "We don't know why this occurs. Every internist faces this problem in his male patients and has no options to offer. Our study shows Cialis may help."
Men with No ED Can Have Sexual Dysfunction
Dr. Paduch and his colleagues have long researched issues of sexual dysfunction that extend beyond ED. "Erectile dysfunction isn't the whole story, by any means," he says.
A 2011 study led by Dr. Paduch helped clarify the issue. The largest analysis to date of orgasmic and ejaculatory dysfunction, also published in the British Journal of Urology International, followed nearly 12,130 men with mild to severe ED and found that 65 percent of the participants were unable to have an orgasm and 58 percent had problems with ejaculation. Even men with no or very minimal ED reported poor ejaculatory function (17 percent) and poor ability to have an orgasm (22 percent). At the time, Dr. Paduch pointed out that approximately 30 million American men -- half of all men aged 40 to 70 -- have trouble achieving or sustaining an erection. "While medications like Viagra and Cialis have been successful in helping many of these men, our research suggests there are other common sexual issues that remain largely unaddressed," he said in 2011.
Non-erectile sexual dysfunction is underreported and undertreated due to social stigma and, in particular, misunderstandings about the physiology of male sexual response and orgasmic dysfunction, Dr. Paduch says. "For decades it was believed that only women had problems with orgasm, but our research shows that orgasmic dysfunction could be as prevalent among men as it is among women."
In this new study, Dr. Paduch and his colleagues examined data from 17 placebo-controlled 12-week trials of Cialis, given at different doses. These studies included 3,581 participants with a mean age of 54.9, including 1,512 men with severe ejaculatory dysfunction (EJD) and 1,812 with severe orgasmic dysfunction (OD). In some cases, patients with one or both of these conditions reported only mild or moderate ED.
The researchers examined the study participants' responses on questionnaires about the effect Cialis had on ED, EJD, and OD, among other measures of sexual satisfaction. The original questionnaire was primarily focused on the effects of Cialis on ED, but provided valuable additional information.
They found that treatment with Cialis (10 or 20 milligrams taken as needed) was associated with significant increase in ejaculatory and orgasmic function across all levels of severity of ED, EJD and OD, compared to use of a placebo agent.
For example, 66 percent of men with severe EJD and 66 percent with severe OD who used Cialis reported improved ejaculatory function, compared with 36 percent and 35 percent, respectively, in the placebo group. Also, patients with moderate dysfunction also experienced significant improvements with Cialis, Dr. Paduch reports.
"More study is needed, but we are hopeful our findings may lead to a treatment for many men who cannot now achieve sexual satisfaction," Dr. Paduch says.
Other study co-authors include Alexander Bolyakov, a research associate in the Department of Urology at Weill Cornell, and Paula K. Polzer and Steven Watts, the study's senior investigator, both of Lilly Research Laboratories of Eli Lilly.
This research study was funded by Eli Lilly and Company, the manufacturer of Cialis.
Study authors Dr. Paduch and Bolyakov are funded study investigators and consultants for Eli Lilly. In addition, Polzer and Watts are employees of, and minor shareholders in, Eli Lilly.
Weill Cornell Medical College
Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances -- including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston. For more information, visit weill.cornell.edu.
NewYork-Presbyterian Hospital/Weill Cornell Medical Center
NewYork-Presbyterian Hospital/Weill Cornell Medical Center, located in New York City, is one of the leading academic medical centers in the world, comprising the teaching hospital NewYork-Presbyterian and Weill Cornell Medical College, the medical school of Cornell University. NewYork-Presbyterian/Weill Cornell provides state-of-the-art inpatient, ambulatory and preventive care in all areas of medicine, and is committed to excellence in patient care, education, research and community service. Weill Cornell physician-scientists have been responsible for many medical advances--including the development of the Pap test for cervical cancer; the synthesis of penicillin; the first successful embryo-biopsy pregnancy and birth in the U.S.; the first clinical trial for gene therapy for Parkinson's disease; the first indication of bone marrow's critical role in tumor growth; and, most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. NewYork-Presbyterian Hospital also comprises NewYork-Presbyterian Hospital/Columbia University Medical Center, NewYork-Presbyterian/Morgan Stanley Children's Hospital, NewYork-Presbyterian Hospital/Westchester Division and NewYork-Presbyterian/The Allen Hospital. NewYork-Presbyterian is the #1 hospital in the New York metropolitan area and is consistently ranked among the best academic medical institutions in the nation, according to U.S.News & World Report. Weill Cornell Medical College is the first U.S. medical college to offer a medical degree overseas and maintains a strong global presence in Austria, Brazil, Haiti, Tanzania, Turkey and Qatar. For more information, visit www.nyp.org.