Title:Overall Sexual Function in Dysmetabolic Obese Men with Low Testosterone
Levels Treated with Clomiphene Citrate
Volume: 22
Issue: 8
Author(s): Carla Pelusi, Nicola Bartolomeo, Giuseppe Lisco, Margherita Baccini, Flaminia Fanelli, Giovanni De Pergola, Vincenzo Triggiani, Uberto Pagotto and Vito Angelo Giagulli*
Affiliation:
- National Institute of Gastroenterology
"Saverio de Bellis," Research Hospital, Castellana Grotte, Bari, Italy
- Outpatients Clinic of Endocrinology and Metabolic Disease, Conversano Hospital,
Conversano, Bari, Italy
Keywords:
Clomiphene citrate, international index of erectile function, IIEF-15, hypogonadism, metabolism, randomized controlled trial, sexual functions, Dysmetabolic Obese Men, testosterone.
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 aimed 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 found to be associated with a neutral effect on overall
sexual function.
