Lodenafil Carbonate: Reproductive and Developmental Evaluation

Abstract

Lodenafil, is one new orally‐active, potent and selective inhibitor of the enzyme phosphodiesterase 5 (PDE5) developed in Brazil, with therapeutically application in erectile dysfunction. The objective of this study was to evaluate the reproduction toxicity and in offspring, evidencing specifically the occurrence of possible toxic effects in the fertility, gestation, maternal behavior and lactation, as well as growth and postnatal development of F1 since its birth, up to 4 days. Wistar rats received daily: metilcelulose, (2 control groups); 5,7mg/kg, 28,4mg/kg and 142mg/kg (2 groups of 10 males and 10 females in each dose).Drug administration occurred during 35 and 14 consecutive days for males and females, respectively. Animals had been observed for detention of possible clinical and behavior alterations, delivery, and other toxic signals including morbidity or mortality, gestation time, litter size number of each sex, total living pups and corporal weight of the offspring.Litter components had been analyzed in the maximum 24 h after the birth, and the evaluation repeated in all first 4 days after‐birth. No remarkable toxicity was found in the offspring even in the presence of maternal toxicity, no significant decrease in body weight gain was observed, decrease in offspring righting reflex and increase in litter size, were observed.FellowshipCristália Produtos Químicos e Farmacêuticos, Instituto Royal