Testosterone, clomiphene yield similar satisfaction

Orlando, FL-Symptomatic hypogonadal men treated with clomiphene citrate (Clomid) or testosterone gels report similar satisfaction levels as age-matched men treated with testosterone injections, despite having significantly lower serum total testosterone levels, according to the findings of a recent retrospective study from Baylor College of Medicine, Houston.

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Men included in the cross-sectional study, which was published online ahead of print in the Journal of Urology (March 20, 2014), were identified by reviewing charts of 1,150 symptomatic hypogonadal patients (total testosterone <300 ng/dL) who presented to the Baylor urology clinic between May 2013 and January 2014. Four age-matched groups of 31 men each were created comprising three testosterone supplementation cohorts treated with clomiphene, testosterone injections, or testosterone gel and a control group of untreated men.

Men in the testosterone supplementation groups had to have a follow-up testosterone level after being on treatment for at least 6 months and scores from the quantitative androgen deficiency in aging male (qADAM) questionnaire completed on the same day as the follow-up testosterone blood draw. qADAM scores for the control group were from questionnaires completed at presentation to the clinic.

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Mean testosterone increased significantly in all treated groups: from 247 to 504 ng/dL in clomiphene-treated men, 224 to 1,104 ng/dL in the testosterone injection group, and 230 to 412 ng/dL in men using testosterone gel. Pairwise comparisons showed the follow-up testosterone level was significantly different between the testosterone injection and clomiphene groups, but not between the clomiphene and testosterone gel groups.

There were no statistically significant differences in mean qADAM scores among the clomiphene, testosterone injection, and testosterone gel groups (35, 39, and 36, respectively), and interestingly, they were also not significantly different compared to the men not on testosterone supplementation (34).

Ranjith Ramasamy, MD“The efficacy of oral clomiphene citrate for increasing testosterone levels and improving ADAM scores in hypogonadal men has been reported, but we were interested in evaluating how satisfied patients were with their outcomes. Based on use of a validated, standardized questionnaire, it appears that overall satisfaction is similar in men taking clomiphene and those on injectable and topical forms of testosterone replacement,” said first author Ranjith Ramasamy, MD, fellow in male reproductive medicine and surgery at Baylor College of Medicine, who presented the findings at the AUA annual meeting in Orlando, FL.

Study design a limitation

However, he noted the study has limitations.

“Due to our study’s retrospective cross-sectional design, we do not know the pre-treatment and final qADAM scores, and so we cannot compare the different treatment groups for improvement with therapy,” Dr. Ramasamy said.

“In addition, we also acknowledge that our conclusion about similar patient satisfaction may not necessarily be generalized to older men,” added Dr. Ramasamy, who worked on the study with Larry Lipshultz, MD, and colleagues.

Analyses of the scores for the individual items in the qADAM questionnaire showed a significant difference between groups only in the rating of libido, which was significantly higher among men receiving the testosterone injections (4, “good”) compared to the testosterone gel, clomiphene, and control groups (3, “average,” for all comparators; p≤.04).

“Based on this finding, we would counsel men who particularly complain about low libido that they may be more satisfied with testosterone injections,” Dr. Ramasamy told Urology Times.

Dr. Lipshultz has a financial interest and/or other relationship with Auxilium Pharmaceuticals, Endo, and Repros Therapeutics.UT

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