“Premature ejaculation or PE is the most common sexual dysfunction, affecting one in four men, yet we have limited options that really help men manage it,” said study investigator and presenter Ridwan Shabsigh, MD, Chairman of Surgery,
The Phase 4 double-blind, randomized, placebo-controlled clinical study met its primary endpoint of change in average Intravaginal Ejaculatory Latency Time (IELT) at two months, as well as secondary outcomes of change in questionnaire assessments including global rating of distress, medication assessment and Index of Premature Ejaculation (IPE). After treatment with PREBOOST, 82 percent of men were no longer considered to have PE while being treated and reported a statistically significant better sense of ejaculation control, confidence, satisfaction, sexual pleasure, increased length of intercourse and reduced frustration. Treatment was well tolerated and no transference of product was reported.
“We’re excited about these clinical data and what our product can do for men who have really had no options and desire a simple solution to PE,” said Mitchell Steiner, MD, President and Chief Executive Officer,
The product was created and is being developed by company cofounder and practicing urologist Harry Fisch, MD, largely in response to a need he saw with his patients.
Study investigator Dr. Ridwan Shabsigh will present the full clinical results of Double-Blind, Randomized Controlled Trial of Topical 4% Benzocaine Wipes for Management of Premature Ejaculation, abstract PD69-02, during a podium presentation at the AUA annual meeting from
The study enrolled 26 men aged 18 years or older in a heterosexual, monogamous relationship, with PE, defined as reported poor control over ejaculation, personal distress related to ejaculation and average intravaginal ejaculatory latency of two minutes or less on stopwatch measurement. Subjects were randomized 2:1 to treatment with benzocaine wipes or placebo wipes, with men in the placebo group crossed over to the treatment group one month after randomization.
The primary outcome measure for the study was change in IELT at two months, with secondary outcomes including change in questionnaire assessments of global rating of distress, medication assessment and Index of Premature Ejaculation (IPE). A Wilcoxon rank-sum test was utilized for all comparison outcomes.
The analysis was conducted in 26 men who were randomized (17 treatment, 9 placebo) and had complete follow-up data. Data showed that patients treated with benzocaine 4% wipes demonstrated a statistically significant improvement in IELT after the first month of treatment (2.75 minutes), with greater improvement after the second month (5.5 minutes), compared to placebo (1.8 minutes). Men in the treatment group also reported greater improvement in distress relating to intercourse, control of ejaculation and satisfaction with sexual intercourse over the study period.
Results showed that treatment was well tolerated. Two treated men experienced adverse events, including mild headache and back pain and mild irritation on the penis, which resolved spontaneously.
Funding for the study was provided by
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Contacts: Erinn White Centron PR 646-722-8822 EWhite@centronpr.com Kevin Gilbert
Press Release Kari Sharp