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Nebido improves sexual function in severe hypogonadism
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Men with severe hypogonadism reported improved sexual function after testosterone replacement therapy with Nebido, study results show.
However, sexual function scores for men with mild hypogonadism were mostly unchanged after therapy. The researchers recommend at least 30 weeks of treatment before evaluation of improvement in erectile dysfunction.
“By mixing mild and severe hypogonadism cohorts, previous investigators may have underestimated the potential benefits of testosterone supplementation on sexual function. The benefits in sexual function were still increasing at 30 weeks suggesting that trials of testosterone therapy need to be continued for at least 6 months,” Geoffrey Hackett, MD, FRCPI, MRCGP, a consultant in sexual medicine at Good Hope Hospital in the United Kingdom, told Endocrine Today.
Geoffrey Hackett
Hackett and colleagues evaluated men with type 2 diabetes and severe or mild hypogonadism from seven primary care centers in England from September 2008 to June 2012. Participants were randomly assigned to 30 weeks of treatment with Nebido (long-acting testosterone undecanoate injection, Bayer AG; mild hypogonadism, n = 56; severe hypogonadism, n = 30) or placebo (mild hypogonadism, n = 51; severe hypogonadism, n = 52). Mild hypogonadism was defined as total testosterone of 8.1 nmol/L to 12 nmol/L or free testosterone of 0.18 nmol/L to 0.25 nmol/L, and severe hypogonadism was defined as total testosterone of 8 nmol/L or less and free testosterone of 0.18 nmol/L or less.
Researchers sought to determine the effect of the treatment with testosterone undecanoate compared with placebo for changes in sexual function.
Researchers administered the 15-item International Index of Erectile Function questionnaire to assess erectile function, intercourse satisfaction, orgasmic function and sexual desire at baseline and at 6, 18 and 30 weeks.
After 30 weeks, compare with baseline, erectile function, intercourse satisfaction and sexual desire scores increased in the severe hypogonadism testosterone treatment group (P = .038, P = .0035 and P = .0001, respectively). Intercourse satisfaction decreased in the severe hypogonadism placebo group.
Among men with mild hypogonadism in either the treatment or placebo group, no changes from baseline were found in scores for erectile function, intercourse satisfaction or orgasmic function scores at any time point. Compared with the placebo group, men with severe hypogonadism in the treatment group reported higher erectile function scores at 30 weeks (P = .0036) and higher intercourse satisfaction scores at weeks 6 (P = .0017), 18 (P = .0002) and 30 (P = .0051). Greater increases were observed in sexual desire scores among participants with mild hypogonadism in the treatment group compared with the placebo group at weeks 18 (P = .031) and 30 (P = .05). and among the treated severe hypogonadism group compared with the mild hypogonadism group at weeks 6 (P = .0002), 18 (P = .0001) and 30 (P < .0001).
“The study endorses the view of the Endocrine Society that the burden of [hypogonadism]-related sexual dysfunction in men is evident at [total testosterone] up to 8 nmol/L. [Testosterone undecanoate] produced significant benefit in all domains of sexual function we studied in men with [total testosterone] up to 8 nmol/L. In contrast, only sexual desire improved significantly with [testosterone replacement therapy] in those with mild [hypogonadism],” the researchers wrote.
“Only by routinely measuring testosterone levels in men with type 2 diabetes and erectile dysfunction, will physicians be able to target men most likely to respond to testosterone supplementation,” Hackett said. – by Amber Cox
For more information:
Geoffrey Hackett, MD, FRCPI, MRCGP can be reached at Department of Urology, Good Hope Hospital, Heart of England Foundation Trust, Sutton Coldfield, West Midlands, United Kingdom, B75 7RR; email: geoff.hackett@virgin.net.
Disclosure: Hackett reports being an occasional speaker for Bayer and Lilly. The study was supported by a grant from Bayer to cover practice expenses. No other financial disclosures were reported.
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