OBJECTIVE: To determine the effect of enclomiphene citrate in men with secondary hypogonadism. DESIGN: Phase II clinical trial. SETTING:Community dwelling men making visits to physician offices. PATIENT(S): Men with secondary hypogonadism. INTERVENTION(S): Oral administration of enclomiphene citrate or 1% topical T gel. MAIN OUTCOME MEASURE(S): Luteinizing hormone, FSH, T, and semen analysis. RESULT(S): Treatment with enclomiphene citrate resulted in increased morning serum T, E2, and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism. Follicle-stimulating hormone and LH were increased with enclomiphene, and sperm counts were conserved. CONCLUSION(S): Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism, namely, low serum total T and low or inappropriately normal LH while preserving sperm production. CLINICAL TRIAL REGISTRATION NUMBER: NCT01270841 (ClinicalTrials.gov Identifier NCT01270841).
RCT Entities:
OBJECTIVE: To determine the effect of enclomiphene citrate in men with secondary hypogonadism. DESIGN: Phase II clinical trial. SETTING: Community dwelling men making visits to physician offices. PATIENT(S): Men with secondary hypogonadism. INTERVENTION(S): Oral administration of enclomiphene citrate or 1% topical T gel. MAIN OUTCOME MEASURE(S): Luteinizing hormone, FSH, T, and semen analysis. RESULT(S): Treatment with enclomiphene citrate resulted in increased morning serum T, E2, and LH levels similar to those obtained with a topical T gel in men with secondary hypogonadism. Follicle-stimulating hormone and LH were increased with enclomiphene, and sperm counts were conserved. CONCLUSION(S): Enclomiphene citrate reverses the two hallmarks of secondary hypogonadism, namely, low serum total T and low or inappropriately normal LH while preserving sperm production. CLINICAL TRIAL REGISTRATION NUMBER: NCT01270841 (ClinicalTrials.gov Identifier NCT01270841).
Authors: Maria Camila Suarez A; Joseph M Israeli; Eliyahu Kresch; Leon Telis; Daniel E Nassau Journal: Int J Impot Res Date: 2022-01-07 Impact factor: 2.896