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| |  AUA: Supplemental Testosterone Enhances Hypogonadal Men's Sildenafil Response By Paula Moyer CHICAGO, IL -- May 1, 2003 -- Men with erectile dysfunction (ED) who have inadequate responses to sildenafil (Viagra) with low testosterone respond to topical testosterone gel. "Our research shows for the first time that the combination of sildenafil and testosterone gel is well tolerated," said Ridwan Shabsigh, MD, associate professor of urology at the College of Physicians and Surgeons, Columbia University, and director of the New York Center for Human Sexuality, Columbia Presbyterian Medical Center, in New York. Dr. Shabsigh presented the findings here on April 28th at the 98th Annual Meeting of the American Urological Association. He stressed that physicians need to continue to individualize their treatment of men with ED, since "not all low-testosterone men fail to respond to sildenafil in real life." Prior research suggested that the nitric oxide erectile pathway might be testosterone dependent. Furthermore, physicians who treat men with ED have observed a suboptimal response to sildenafil in men with both hypogonadism and ED, Dr. Shabsigh said. To assess the effect and safety of testosterone gel 1% with sildenafil in hypogonadal men with ED who had not responded to sildenafil monotherapy, Dr. Shabsigh and colleagues conducted a multicenter, double-blinded placebo-controlled study. They enrolled 75 men with ED, average age 58.5 years, who had either low or low-normal testosterone (<400 ng/dL collected before 10:00 a.m.) and had not responded to sildenafil. The treatment arm received 5 g of testosterone gel 1% and 100 mg of sildenafil, and the control arm received placebo gel and 100 mg of sildenafil for 12 weeks. All had had ED for at least 3 months and were in a stable heterosexual relationship. Lack of response to sildenafil was defined as a score of 2 or 3 on each of questions 3 and 4 of the International Index of Erectile Function (IIEF). The investigators primarily assessed subjects' mean change from baseline in the erectile function domain of the IIEF and mean change from baseline in each of the remaining 4 domains, as well as their total score. They assessed the safety of the treatment with a physical exam, a urologic exam, measurement of prostate-specific antigen (PSA) levels, a voiding specimen, and lab tests. They also watched for the adverse effects typically associated with sildenafil, such as headache, flushing, and heartburn. Interim analysis on 67 subjects at week 4 showed that testosterone gel was associated with a significant response to sildenafil on the erectile function (P=0.037), orgasmic function (P=0.019), and overall satisfaction (P=0.046) domains of the IIEF questionnaire. Testosterone-treated men also had a significantly higher total score (P=0.022), Dr. Shabsigh said. There was no significant difference in sexual desire or satisfaction with intercourse between the two groups, he noted. "We found that testosterone replacement therapy with testosterone gel 1% improves erectile response to sildenafil in these men," Dr. Shabsigh said. "Therefore, this treatment may be considered for men with low to normal testosterone who have not experienced success with sildenafil."
[Study title: Testosterone Replacement Therapy With Testosterone-Gel One% Convert Sildenafil Non-Responders to Responders in Men With Hypogonadism in Erectile Dysfunction Who Failed Prior Sildenafil Therapy. Abstract 954]
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