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Premature Ejaculation Drug Improves Control, Satisfaction and Time

Data presented today demonstrates that men taking dapoxetine hydrochloride for the treatment of premature ejaculation (PE) experienced significant improvements in sexual function, including ejaculatory control, satisfaction with sexual intercourse for men and their partners, and increases in intravaginal ejaculatory latency time (IELT)*. The U.S. Food and Drug Administration is currently reviewing a New Drug Application for dapoxetine, which if approved, would be the first prescription product indicated for the treatment of PE. These data were presented at the 100th Annual Scientific Meeting of the American Urological Association.

According to the American Urological Association, premature ejaculation may be the most common male sexual disorder. It is estimated that PE may affect 27 percent to 34 percent of men across all age ranges**, in contrast to erectile dysfunction, which is estimated to affect 10 percent to 12 percent of all men, who are usually older in age. PE can be a lifelong condition experienced from the beginning of sexual activity or can develop after years of satisfactory sexual activity.

"The impact premature ejaculation can have on men and their partners can be devastating for a relationship and, currently, there are no truly optimal therapies for PE," says Jon L. Pryor, M.D., chairman and program director of the Department of Urologic Surgery at the University of Minnesota and lead investigator of the dapoxetine phase III clinical trials. "The results with dapoxetine are compelling. They demonstrate that, for the first time, a medicine can be taken by men on an on-demand basis and provide significant improvement in their PE condition. The unique profile of dapoxetine translated into targeted treatment of PE compared to existing therapies. There are meaningful improvements in this study across all primary and secondary endpoints, including a three-to-four fold increase in IELT."

Phase III Trial Design and Results

The phase III clinical trials studied 2,614 men with PE aged 18-77 in monogamous sexual relationships of greater than six months. PE was defined as persistent or recurrent ejaculation sooner than desired either before or shortly after penetration, typically reflecting an IELT of two minutes or less, over which the sufferer has minimal or no control.

Men in the studies were randomized to receive 30 mg or 60 mg of dapoxetine over 12 weeks in two identical, double-blind, placebo-controlled, multicenter trials. Patients were asked to take study medication one-to-three hours before intercourse. Participants had IELT of two minutes or less in at least 75 percent of intercourse episodes occurring during the two-week baseline run-in period prior to treatment.

The studies examined changes from baseline for mean IELT as monitored by a stopwatch; measured the subject's ejaculatory control and sexual satisfaction on a five-point scale from "very poor to very good" and measured the partner's satisfaction with sexual intercourse from "very poor to very good." The results showed:

* Men taking dapoxetine 30 mg and 60 mg experienced more than a three-to-four fold increase in mean IELT compared with placebo (P-value <0.0001 at 30 mg and 60 mg). IELT increased significantly with the first dose of dapoxetine, and increases in IELT were maintained over the 12-week study period.
* The percentage of men rating control over ejaculation as "fair to very good" increased dramatically for dapoxetine 30 mg (2.5 percent to 51.8 percent) and 60 mg (3.3 percent to 58.4 percent) compared to placebo (3.5 percent to 26.4 percent).
* The percentage of men rating sexual satisfaction as "good to very good" almost doubled with dapoxetine 30 mg (20.2 percent to 38.7 percent) and 60 mg (22.3 percent to 46.5 percent), respectively, in comparison to placebo (21.6 percent to 24.6 percent).
* The percentage of partners rating sexual satisfaction as "good to very good" almost doubled with dapoxetine 30 mg (20.4 percent to 39 percent) and 60 mg (24.8 percent to 47.4 percent), respectively, compared to placebo (20.1 percent to 25.2 percent).

The study also found that dapoxetine was generally well tolerated, with most side effects of mild-to-moderate severity. The most common adverse events reported with both 30 mg and 60 mg doses of dapoxetine were nausea, followed by headache.

About Premature Ejaculation (PE)

Although PE is one of the most common male sexual disorders, it remains widely under-diagnosed and under-treated. Most physicians do not screen for PE and patients are extremely reluctant to talk about the condition with their partners or health care professionals. PE can have a significant impact on many aspects of a man's life. It can affect his and his partner's sexual satisfaction and their ability to build and maintain relationships – both sexual and non-sexual – and can impact a man's general sense of self-confidence.

An observational study published in the May 2005 issue of The Journal of Sexual Medicine found that patient-reported outcome measures (PROs), such as control over ejaculation, satisfaction with sexual intercourse and distress are important factors in assessing the benefit of treatments for PE in clinical studies. The study found that men with PE and their partners reported higher ratings for interpersonal difficulty, lack of control over ejaculation and dissatisfaction with sexual intercourse.

About Ortho Urology

Ortho Urology, a unit of Ortho-McNeil Pharmaceutical, Inc., has a proven track record of leadership in the field of urology and is committed to providing patients with products that help them live healthier lives and improve their quality of life. Ortho Urology has a history of clinical expertise and is committed to bringing patients the most advanced options in urology with products such as ELMIRON® (pentosan polysulfate sodium) and DITROPAN XL® (oxybutynin chloride).

* Intravaginal Ejaculatory Latency Time (IELT) – IELT was first introduced in 1994. It is used in clinical setting involving the study of premature ejaculation. A stopwatch may be operated by either partner and is activated when the male enters the female and stopped when a man ejaculates. The amount of time this process takes is known as intravaginal ejaculatory latency time or IELT.

** Represents Hispanic, Caucasian and African American men.




Submitted by BJS on Tue, 2005-05-24 16:27.

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Premature Ejaculation Stop For Good

Submitted by Anonymous on Fri, 2008-06-06 22:47.

Hi Guys , This is a story hits close to home for me. I suffered from pre mature ejaculation syndrome & lack of performance during sex with women. I would come pre maturely just touching their vaginal area. All the excitement from the touching , caressing , kissing , feeling caused me to shot immediately. I could not control it. I was never able to be inside them & I was already done. I lost many women in my life due to this problem. The women were extremely disappointed & angry. I do not blame them.

As I fully went to orgasm , they were just started getting turned on or really horny. I felt like a worthless fool not able to satisfy the women who loved me. Some of them were understanding but for a limited time. Eventually all women left me because I could not full fill their sexual needs. This problem became so severe that it caused break ups , problems with relationships in my life. I was so afraid when it came to sexual activity that I would pretend to be to tired , have a book next to have an excuse to read , saying I have a lot of things on mind , ... excuses for me not to have sex.

This seems weird & awkward due to my age range. I was in my mid 20's. I was in my sexual prime & I was refusing sex ??? All men would say I am crazy to refuse this awesome feeling. The reason was I suffered from pre mature ejaculation & performance. It was not that I did not want sex , but I was embarrassed & scared due to this problem. I was so depressed by all these women leaving me for other men that can satisfy them. I turned to medical help : doctors , sex therapists , specialists , etc... Even with their help was limited. I bought over the counter drugs , lotions , creams , pills , etc... I spent a lot of time & money & none of these things worked. I also bought dvds , literature , etc... which did not help either.

I was getting DESPERATE due to feeling lonely & alone. I wanted to try anything. I stumbled upon the Ejaculation Master. Needless to say , I bought the program. I felt this was my last chance to cure my problem. I followed the program precisely. The program took about an half hour a day. 3-7 times a week for about a month. It was structured for training with or without partner. I did not have a partner which was good. This allowed me to practice by myself without anyone seeing me.

Anyway , I put it to the test after practicing the techniques for 2 months. I took more time to train myself to master techniques outlined in course. I wanted to see if this program was a fluke so I went hire an escort. I was AMAZED by the results. I did not come for a least 45 minutes & felt the whole sexual power of real intercourse. But I wanted to prove it again to myself that this program works. Next , I wanted to try it on 1 of my ex girlfriends to see if she would notice the difference. She still cared about me so I had the chance to be intimate with her again. She noticed an IMMEDIATE change as I did not come. I was able to be inside her for a good 45 min. before anything happened. She climaxed 4-5 times she told me before I came. That was a nice change for once.

With this program I have no more fear of this problem again. Along with the self confidence to perform with the sexual stamina that I never had before. I am writing this from personal experience so I can help fellow guys not to be embarrassed & suffer what I did. There is a way to eliminate & prolong your sexual power & stamina. If you suffer from pre mature ejaculation then there is a solution : Ejaculation Master. This program changed my life & it will change yours too. Thanks for the read , Doug

Check them out @ http://www.the-satisfy-lover.com/

  • reply

Gudnason's program

Submitted by Anonymous on Fri, 2008-05-09 11:22.

Oops, I meant to post this here:

Gudnason's program, which also worked for my husband, can be found here:

www.solvepremature-ejac.com

He had tried everything else and this was the only thing that worked.

  • reply

I Agree, Don't Take a Drug

Submitted by Anonymous on Fri, 2008-05-09 11:18.

My husband also had great success with Christian Gudnason's program, which I recommend as well. You can access it here:

www.solvepremature-ejac.com

give it a go and see what you think

  • reply

Premature ejaculation drugs

Submitted by Anonymous on Tue, 2008-04-08 07:43.

I was suffering from premature ejaculation and because of the pressure from my partner, I tried many medicines and techniques to control my early ejaculation. I tried synthetic chemical drugs like dapoxetine hydrochloride. I will say that such drugs can have some effect to delay the orgasm, but it has many side effects just like that of drugs like prozaic. I would therefore recommend guys who are suffering from PE to try natural herbal medicines like 'Himalayan Niagra'. This medicine does not have any side effects and does not drain your pocket too. It comes with a money-back guarantee. I tried it and got the results, so I am recommending it here. You can find more details at the company website

http://www.HimalayanNiagra.com

  • reply

prevention drug

Submitted by Anonymous on Thu, 2008-03-27 08:50.

So I guess what the pharmaceutical companies are trying to tell us is that there is no risk involved with taking this medicine? Maybe there isn't, but after all the cases I've seen in rehab clinics, many of which started with such "useful" drugs, I doubt it.

  • reply

I used to suffer from

Submitted by Anonymous on Tue, 2008-03-11 23:09.

I used to suffer from Premature Ejaculation too. It's not the end of the world because it's curable. Try out these websites to see if it can help you:

http://www.squidoo.com/premature-ejaculation-cures

http://mens-health-blog.blogspot.com/

  • reply

About Dapoxetine

Submitted by treat premature ejaculation (not verified) on Sun, 2007-12-30 13:42.

Yes it suxx. And I doubt it will be approved by the FDA soon because ssris come with undesirable side-effects after long-term use (you'll need 2-4 month to treat premature ejaculation), such as psychiatric problems, dermatological reactions, lower sex-drive, headache, upset stomach and weakness, thus not significantly outweighing the benefit of premature ejaculation medication versus the risks.

  • reply

Last I heard, this drug

Submitted by Anonymous on Mon, 2007-11-12 22:54.

Last I heard, this drug failed the FDA test and was denied production, right? That sucks because it would be such a life saver for most guys with PE. Not only will that drug company bank in the money, but it will keep the customers happy as well!

I did cured my PE after many months of research and a lot of trial and error with products (spray, de-sensitizers) and most have failed or only provide temporary solutions to the problem. People got to understand that there are different kind of PE and it's easier to cure if you know which kind you have. What worked for me and I highly suggest is the book by Dr. Christian Gudnason “The Ejaculation Master”, it tells and help you identify what kind of PE you have and will show you methods and exercises to slowly (it takes time but well worth it) cure the evil PE problem.

The book helped me overcame my PE problem, I won’t promise you that it will cure yours but it’s worth a try.

  • reply

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