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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
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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“can virtually guarantee an erection for successful intercourse [40].”
From Erectile dysfunction and its pharmacology: An overview (2017) · cites this paper as [40]
In the citing paper
“Testosterone replacement therapy in two studies was found to convert sildenafil nonresponders to responders (18,19).”
From Clinical and Biochemical Assessment of Hypogonadism in Men With Type 2 Diabetes (2007) · cites this paper as [18]
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Metadata
- Authors
- SHABSIGH, R., KAUFMAN, J. M., STEIDLE, C., & PADMA-NATHAN, H.
- Affiliations
- University of Southern California (US)
- Venue
- Journal of Urology
- Published
- 2004-08
- Volume
- 172
- Issue
- 2
- Pages
- 658-663
- ISSN
- 0022-5347 (ISSN-L)
- 1527-3792
- 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
- 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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