Cited by 406Sexual function and dysfunction studiesHormonal and reproductive studiesUrological Disorders and Treatments

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RANDOMIZED STUDY OF TESTOSTERONE GEL AS ADJUNCTIVE THERAPY TO SILDENAFIL IN HYPOGONADAL MEN WITH ERECTILE DYSFUNCTION WHO DO NOT RESPOND TO SILDENAFIL ALONE

SHABSIGH, R., KAUFMAN, J.M., STEIDLE, C., PADMA-NATHAN, H.·2004·Journal of Urology

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Abstract

PURPOSE: We compare the efficacy of testosterone gel (T-gel) versus placebo as adjunctive therapy to sildenafil in hypogonadal men with erectile dysfunction who do not respond to sildenafil alone. MATERIALS AND METHODS: A randomized, placebo controlled, double-blind, parallel group, multicenter study was performed. A total of 75 hypogonadal men (18 to 80 years old, morning serum total testosterone 400 ng/dl or less) with confirmed lack of response to sildenafil monotherapy were randomized (1:1) to receive a daily dose of 1% T-gel or 5 gm placebo gel as adjunctive therapy to 100 mg sildenafil during a 12-week period. Subjects were evaluated for sexual function, primarily based on the International Index of Erectile Function (IIEF), quality of life and serum testosterone levels at baseline and weeks 4, 8 and 12. RESULTS: Testosterone treated subjects had greater improvement in erectile function compared to those who received placebo, reaching statistical significance at week 4 (4.4 vs 2.1, p = 0.029, 95.1% CI 0.3, 4.7). Similar trends were observed for improvements in orgasmic function, overall satisfaction, total IIEF score and percentage of IIEF responders. T-gel significantly (p < or =0.004) increased total and free testosterone levels throughout the study, although no significant correlations were made between testosterone levels and the IIEF at end point. CONCLUSIONS: T-gel taken with sildenafil may be beneficial in improving erectile function in hypogonadal men with erectile dysfunction who are unresponsive to sildenafil alone.

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Authors: SHABSIGH, R., KAUFMAN, J. M., STEIDLE, C., & PADMA-NATHAN, H.
Affiliations: University of Southern California (US)
Venue: Journal of Urology
Publisher: Ovid Technologies (Wolters Kluwer Health)
Published: 2004-08
Volume: 172
Issue: 2
Pages: 658-663
ISSN: 0022-5347 (ISSN-L)
1527-3792
DOI: 10.1097/01.ju.0000132389.97804.d7
OpenAlex: W2121881032
Cited by: 406
References: 9
Citations by year: 2026: 1 · 2025: 5 · 2024: 3 · 2023: 5 · 2022: 5 · 2021: 8 · 2020: 8 · 2019: 5 · 2018: 9 · 2017: 9 · 2016: 16 · 2015: 7 · 2014: 29 · 2013: 33 · 2012: 18
FWCI: 25.28
Type: journal article
Language: en
Open access: closed
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
Locations: The Journal of Urology (publishedVersion)
PubMed (publishedVersion)
Topics: Health Sciences › Medicine › Psychiatry and Mental health › Sexual function and dysfunction studies
Health Sciences › Medicine › Endocrinology, Diabetes and Metabolism › Hormonal and reproductive studies
Health Sciences › Medicine › Urology › Urological Disorders and Treatments
Keywords: testosterone gel, sildenafil, erectile dysfunction, hypogonadism, adjunctive therapy, testosterone replacement therapy, International Index of Erectile Function, serum testosterone levels, male sexual function
MeSH terms: Sildenafil Citrate, Adolescent, Adult, Aged, Aged, 80 and over, Double-Blind Method, Drug Therapy, Combination, Gels, Humans, Hypogonadism, Erectile Dysfunction, Male, Middle Aged, Phosphodiesterase Inhibitors, Piperazines, Purines, Quality of Life, Sulfones, Testosterone, Treatment Failure

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RANDOMIZED STUDY OF TESTOSTERONE GEL AS ADJUNCTIVE THERAPY TO SILDENAFIL IN HYPOGONADAL MEN WITH ERECTILE DYSFUNCTION WHO DO NOT RESPOND TO SILDENAFIL ALONE

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