Dallas, Texas (PressExposure) October 24, 2009 -- Data presented today demonstrates that men taking Provailen for the treatment of premature ejaculation (PE) experienced some very significant improvements in sexual function, including ejaculatory control time extension, satisfaction with sexual partners, and increases in intravaginal ejaculatory latency time (IELT)* . The FDA is currently reviewing a new product called Provailen, which if approved, would be the first product indicated for the treatment of PE.
RDK Pharmaceuticals have already taken up the production , marketing and distribution for this new premature ejaculaton product . Provailen is expected to be a very good investment for this pharmacy giant as many men suffer from PE, in recent studies even men without PE show an interest in prolonging their ejaculatory control . RDK Pharmaceuticals feels this will become a common product men want to use to have much great sexual control. This will be similar to the drug called Viagra, many men use Viagra as an enhancement medication and are perfectly healthy. According to the American Urological Association, premature ejaculation is one of the most common male sexual disorders. It is estimated that PE may affect 28 percent to 36 percent of men in all age ranges, in contrast to erectile dysfunction, which is estimated to affect 10 percent to 12 percent of all men. PE typically is a lifelong condition experienced from the beginning of sexual activity as a youth and continuing on to develop after years of satisfactory sexual activity. This is one of the main issues women complain about , Often women think the man is just interested in a quick release, when in fact studies show that a large percentage of men simply cannot control there ejaculation and reach climax within 30 sec to 2 min into the sexual act.
"The impact premature ejaculation has on men their partners often can be devastating for a relationship, 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 .The results with Provailen 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. Studies show if taken 30 min before sexual activity there is a significant increase in ejaculation time. This is a very unique opportunity to provide a product that can finally help eliminate the devastating issues that PE pose for men suffering from premature ejaculation. 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 2,873 men with PE aged 16 - 78 in monogamous sexual relationships of greater than six months, this group was chose to remove the extra excitement created by new sexual encounters. We required a solid base line for clinical study. PE was and is defined as persistent or recurrent ejaculation, much sooner than desired either before or shortly after penetration. Typically reflecting an IELT of 1.5 minutes or less, over which the sufferer has minimal or no control.
Men in the studies were randomized to receive 75 mg or 260 mg of Provailen over 10 weeks in identical, double-blind, placebo-controlled, multicenter trials. Patients were asked to take study medication one-to-two hours before intercourse. Participants had IELT within two minutes or less in at least 78 percent of intercourse reported by participants. The studies examined changes from baseline for mean IELT as monitored by a stopwatch; measured the men's ejaculatory control and sexual satisfaction. This was measured using 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 the following:
* Men taking Provailen 75 mg and 260 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 provailen, and increases in IELT were maintained over the 10-week study period.
*The percentage of men rating control over ejaculation as "fair to very good" increased dramatically for Provailen 75 mg (4.7 % to 55.3 %) and 260 mg (4.9 % to 59.1 %) compared to placebo (1.5 percent to 12.2 percent).
*The percentage of men rating sexual satisfaction as "good to very good" almost doubled with Provailen 75 mg (23.7 % to 38.9 %) and 260 mg (25.4 % to 56.1 %), respectively, in comparison to placebo (12.6 % to 14.9 %).
*Percentage of partners rating sexual satisfaction as "good to very good" almost doubled with Provailen 75 mg (22.6 % to 42.9 %) and 260 mg (29.6 %to 56.3 %), respectively, compared to placebo (15.1 % to 21.3 %).
The study also found that Provailen was generally well tolerated, with most side effects of mild-to-moderate. The most common adverse events reported with both 75 mg and 260 mg doses of Provailen were nausea, followed by headache.
Premature Ejaculation (PE)
Although PE is one of the most common male sexual disorders, it remains widely under-diagnosed and under-treated. Most men are not willing to discuss this with their physicians and often spouses or sexual partners. Most physicians do not screen for PE , patients are extremely reluctant and embarrassed to talk about the condition. This is the primary reason for wide under-diagnoses for PE, with their partners or health care professionals. PE has a significant impact on many aspects of men's lives. It also greatly affects his partner's sexual satisfaction and ability to build and maintain relationships - both sexual and non-sexual - and this impacts a man's general sense of self-confidence, self image or worthiness in many cases.
A 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 a much higher ratings for interpersonal difficulty, lack of control over ejaculation and dissatisfaction with sexual intercourse. The females interviewed made strong comments about their sexual dissatisfaction. Many of the females stated they were considering divorce, received their sexual satisfaction from another lover. Only a relatively small amount of women actually stated it had little or no impact on their relationship of feeling toward their sexual partner.
* 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. This technique is used to produce a base line and also to measure the effects or placebo effect during this study.