1901 DEFINING THE UTILITY OF A CLINICAL CARE PATHWAY FOR CLOMIPHENE CITRATE USE IN MEN WITH HYPOGONADISM

Abstract

You have accessJournal of UrologyInfertility: Therapy1 Apr 20131901 DEFINING THE UTILITY OF A CLINICAL CARE PATHWAY FOR CLOMIPHENE CITRATE USE IN MEN WITH HYPOGONADISM Clarisse R. Mazzola, Darren J. Katz, and John P. Mulhall Clarisse R. MazzolaClarisse R. Mazzola New York City, NY More articles by this author , Darren J. KatzDarren J. Katz New York City, NY More articles by this author , and John P. MulhallJohn P. Mulhall New York City, NY More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2320AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Clomiphene citrate (CC) is an effective treatment for men with hypogonadism (HG). For fear of tachyphylaxis, many clinicians commence CC at low dose and some dose every other day rather than daily. This analysis was undertaken to define if up-titrating dose in men failing to respond to low dose CC is an effective therapeutic approach. METHODS Men with a diagnosis of HG (defined by having 2 separate early morning total T (TT) levels <300 ng/dl) opting for CC therapy constituted the study population. Demographic, comorbidity data, physical and laboratory characteristics were recorded. All patients were started on CC 25 every other day (QOD) and were up-titrated to 50mgs QOD and then eventually 50 mgs daily (QD) if the original dose strategy failed. Laboratory testing was conducted 4 weeks after commencement, 4 weeks after a dose change and every six months thereafter. Response was defined as an increase of ≥200 ng/dl in TT and a TT level ≥400 ng/dl at ≥6 months after commencing CC. ANOVA was conducted comparing TT and LH levels among the three dosing groups. Multivariable analysis was performed on patients failing to respond to CC25 QOD to define predictors of successful response to higher doses. Parameters included in the multivariable model were: patient age, mean testicular volume, varicocele presence, baseline TT, free T and LH levels. RESULTS 112 patients were included with a mean age = 45±19 years. Mean pre-treatment testicular volume = 16±8 mls. Mean baseline T and LH levels were 222±98 ng/dl and 3.8±1.6 (0.1-5.8) IU/ml. On CC25 QOD, 71/112 (63%) patients met the responder definition (TT = 467±190 ng/dl, LH = 12.4±3.6). Of the 41 who were up-titrated to C50 QOD, 32% (13) met the responder definition (TT = 414±212 ng/dl, LH = 8.2±5.2). Of the 28 moving to CC50 QD, 18% (5) met responder definition (TT = 366±166 ng/dl, LH = 7.0±1.6; ANOVA p=0.033 for TT, p=0.025 for LH). On multivariable analysis, the only factors predictive of response to up-titrating CC were: pre-treatment LH level (r=0.51, p<0.01) and pre-treatment LH level ≤6 IU/ml (RR 2.1, p<0.01). CONCLUSIONS These data confirm that about two thirds of men with HG meet a robust responder definition using CC25mgs QOD. Up-titrating permitted 44% of patients not responding to CC25 QOD to meet the responder definition. We believe these data support starting CC at low dose and up-titrating when appropriate giving patients realistic expectations when the latter is necessary. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e779 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Clarisse R. Mazzola New York City, NY More articles by this author Darren J. Katz New York City, NY More articles by this author John P. Mulhall New York City, NY More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...