Nelson Vergel
Founder, ExcelMale.com
Are SERMs safe and effective for the treatment of hypogonadism in men?
Tina Joseph 1, Lawrence M Gibbs 1, Kim Pham 1, Richard Guthmann 2
Abstract
YES. For both normal-weight and obese men with low testosterone levels and hypogonadal symptoms, selective estrogen receptor modulators (SERMs), such as clomiphene citrate (CC) and enclomiphene citrate (EC), appear to be effective and safe for improving serum testosterone levels (strength of recommendation [SOR]: C, disease-oriented outcomes from randomized controlled trials [RCTs] and cohort studies). Studies also show that symptom improvement is comparable to that with exogenous testosterone replacement and similar to eugonadal men (SOR: B, patient-oriented outcomes from retrospective cohort studies).
J Fam Pract. 2022 Jan;71(1):E18-E21. doi: 10.12788/jfp.0342.
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Overall sexual function in dysmetabolic obese men with low testosterone levels treated with clomiphene citrate
Carla Pelusi 1, Nicola Bartolomeo 2, Giuseppe Lisco 3, Margherita Baccini 1, Flaminia Fanelli 1, Giovanni De Pergola 4, Vincenzo Triggiani 3, Uberto Pagotto 1, Vito Angelo Giagulli 5
Abstract
Background: Sexual disorders are the most common clinical manifestations of hypogonadism. Functional hypogonadism is the most frequent form, and clomiphene citrate (CC) has been recently introduced as a possible off-label therapeutic option for these patients.
Objectives: This study aims to evaluate the effects of CC on the overall sexual function in dysmetabolic obese men with low testosterone(T) levels.
Methods: This was a sub-study of a randomized, double-blind, cross-over, placebo-controlled trial that included twenty-four obese or overweight subjects, with impaired glucose tolerance, or type 2 diabetes, and confirmed low total T (≤10.4 nmol/l) levels. Subjects were treated with CC or placebo (Plac) for 12 weeks, with an interval wash-out period of 6 weeks between treatments. All subjects were on metformin 2gr/day and a low-calorie diet. The between-treatment difference in the overall sexual function was assessed by IIEF-15 and a qADAM questionnaire.
Results: IIEF-15 and qADAM questionnaire data were available for 18 individuals. In unadjusted analyses, CC was associated with lower IIEF-15 total, erectile function, and intercourse satisfaction domain scores than Plac. After adjustments for multiple variables, CC was associated with a higher IIEF-15 sexual desire domain score (+0.9 ± 0.8; p<.001) despite a lower qADAM score (-2.1 ± 0.9; p=.008) with respect to Plac. No differences were found for the other domains between groups.
Discussion: The clinical significance of the absolute changes in IIEF-15 and qADAM scores during CC versus Plac is limited. However, CC has a reliable effect on sexual desire, and is also as safe as Plac. According to the sample size, duration of follow-up, and inclusion criteria defined for the main study, further studies are therefore needed to assess the long-term efficacy of CC.
Conclusion: Compared to Plac, CC was associated with a neutral effect on overall sexual function.
Clinical Trial Endocr Metab Immune Disord Drug Targets
. 2022 Mar 4. doi: 10.2174/1871530322666220304110958. Online ahead of print.
Tina Joseph 1, Lawrence M Gibbs 1, Kim Pham 1, Richard Guthmann 2
Abstract
YES. For both normal-weight and obese men with low testosterone levels and hypogonadal symptoms, selective estrogen receptor modulators (SERMs), such as clomiphene citrate (CC) and enclomiphene citrate (EC), appear to be effective and safe for improving serum testosterone levels (strength of recommendation [SOR]: C, disease-oriented outcomes from randomized controlled trials [RCTs] and cohort studies). Studies also show that symptom improvement is comparable to that with exogenous testosterone replacement and similar to eugonadal men (SOR: B, patient-oriented outcomes from retrospective cohort studies).
J Fam Pract. 2022 Jan;71(1):E18-E21. doi: 10.12788/jfp.0342.
-----------------------------------
Overall sexual function in dysmetabolic obese men with low testosterone levels treated with clomiphene citrate
Carla Pelusi 1, Nicola Bartolomeo 2, Giuseppe Lisco 3, Margherita Baccini 1, Flaminia Fanelli 1, Giovanni De Pergola 4, Vincenzo Triggiani 3, Uberto Pagotto 1, Vito Angelo Giagulli 5
Abstract
Background: Sexual disorders are the most common clinical manifestations of hypogonadism. Functional hypogonadism is the most frequent form, and clomiphene citrate (CC) has been recently introduced as a possible off-label therapeutic option for these patients.
Objectives: This study aims to evaluate the effects of CC on the overall sexual function in dysmetabolic obese men with low testosterone(T) levels.
Methods: This was a sub-study of a randomized, double-blind, cross-over, placebo-controlled trial that included twenty-four obese or overweight subjects, with impaired glucose tolerance, or type 2 diabetes, and confirmed low total T (≤10.4 nmol/l) levels. Subjects were treated with CC or placebo (Plac) for 12 weeks, with an interval wash-out period of 6 weeks between treatments. All subjects were on metformin 2gr/day and a low-calorie diet. The between-treatment difference in the overall sexual function was assessed by IIEF-15 and a qADAM questionnaire.
Results: IIEF-15 and qADAM questionnaire data were available for 18 individuals. In unadjusted analyses, CC was associated with lower IIEF-15 total, erectile function, and intercourse satisfaction domain scores than Plac. After adjustments for multiple variables, CC was associated with a higher IIEF-15 sexual desire domain score (+0.9 ± 0.8; p<.001) despite a lower qADAM score (-2.1 ± 0.9; p=.008) with respect to Plac. No differences were found for the other domains between groups.
Discussion: The clinical significance of the absolute changes in IIEF-15 and qADAM scores during CC versus Plac is limited. However, CC has a reliable effect on sexual desire, and is also as safe as Plac. According to the sample size, duration of follow-up, and inclusion criteria defined for the main study, further studies are therefore needed to assess the long-term efficacy of CC.
Conclusion: Compared to Plac, CC was associated with a neutral effect on overall sexual function.
Clinical Trial Endocr Metab Immune Disord Drug Targets
. 2022 Mar 4. doi: 10.2174/1871530322666220304110958. Online ahead of print.
