Login to Access Video or Poster Abstract: MP81-08
Sources of Funding: Repros Therapeutics

Introduction

Objectives: To determine effects of daily oral doses Enclomiphene citrate (EC) in comparison to topical testosterone treatment on total testosterone (TT), LH and FSH changes in semen parameters, changes in testicular volume and cholesterol changes in men with secondary hypogonadism. _x000D_ _x000D_

Methods

Patients and Methods: Results of two randomized, double-blind, double-dummy, placebo-controlled, multi-center, Phase III studies (ZA-304/305) to evaluate two doses of EC versus AndroGel (AG) 1.62% on TT, LH and FSH and sperm counts in overweight men 18-60 years of age with secondary hypogonadism. Subjects in this trial exhibited early morning serum TT levels in the low or low normal range (?300 ng/dL; ?10.1 nmol/L) and had low or normal LH (<9.04 IU/L) levels. Semen samples were collected at the beginning and end of the study EOS). Testicular volume was measured at baseline and 16 weeks of treatment as determined by orchidometry. Serum samples, collected at baseline and 16 weeks, were analyzed for hormone and lipid levels. _x000D_

Results

Results: TT levels were increased between baseline and after 16 weeks of treatment in all treatment groups. EC administration reestablished a more normal diurnal pattern of secretion. FSH and LH levels increased in the EC groups and decreased in the AG group at 16 weeks. EC maintained sperm concentration in the normal range over the treatment period. In contrast there was a marked reduction in spermatogenesis in the AG group. Combined data from the two studies showed normalized morphology strict was significantly improved with EC administration and decreased with AG administration. All men were similar at baseline in testes volume (p = 0.94, ANOVA) by orchidometry. In both studies men on topical testosterone demonstrated decreases in mean testicular volume (-0.86 cm3) and a significant decrease overall compared to the EC (p<0.05) or placebo (p<0.05). Treatment with daily oral enclomiphene citrate lowered serum cholesterol by 18.1 mg/dL over 16 weeks. _x000D_

Conclusions

Conclusions: EC consistently increased serum TT, LH and FSH restoring normal levels of serum testosterone. The effects on TT were also seen with T replacement, via AG, but sperm counts were not maintained and in most cases decreased. EC treatment maintained sperm concentrations in the normal range and morphology strict parameters were improved. EC resulted in a significant increase in testicular volume, whereas treatment with AG resulted in a significant decrease in testicular volume. A significant decrease in cholesterol was seen with EC.

Funding

Repros Therapeutics