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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The insertion of a penile prosthesis can virtually guarantee an erection for successful intercourse.
“can virtually guarantee an erection for successful intercourse [40].”
From Erectile dysfunction and its pharmacology: An overview (2017) · cites this paper as [40]
Testosterone replacement therapy in two studies converted sildenafil nonresponders to responders.
“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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- 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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Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
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