Title:Comparative Randomized Crossover Clinical Study for the Evaluation of Erectile Dysfunction Medications Via Novel Pentagon System
VOLUME: 13 ISSUE: 1
Author(s):Mohamed I. Nounou*, Ghada El Haddad, Fatema El Amrawy, Ola El Gaddar, Ahmed El Yazbi and Ahmed Eshra
Affiliation:Department of Pharmaceutical Sciences, University of Saint Joseph, School of Pharmacy, Hartford, CT 06103, Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Department of Chemical Pathology, Faculty of Medicine, Alexandria University, Alexandria, 21521, Department of Pharmacology, Faculty of Pharmacy, Alexandria University, Alexandria, 21521, Department of Pharmaceutics, Faculty of Pharmacy, Alexandria University, Alexandria, 21521
Keywords:Phosphodiestrase inhibitors, sildenafil, questionnaire, clinical study, safety and efficacy assessment, adulteration,
pentagon, nutraceuticals, tiger king.
Abstract:Introduction: Due to the chaos in the legislation in the Middle East, male enhancement
nutraceuticals may be sold without any registration or evaluation. These products need to be evaluated
with respect to safety and efficacy. Furthermore, cultural and social considerations in the Middle East
prevent the use of international evaluations schemes for erectile dysfunction.
Aim: Evaluating the safety and efficacy parameters of generic and nutraceutical products for erectile
dysfunction in the Middle East through a custom-designed, representable and simple system tailored to
the regional culture.
Methods: 74 healthy male volunteers were enrolled into a comparative, simple randomized, single
dose, double blind, and crossover clinical study incorporated with a tailored-designed questionnaire.
Safety assessment included laboratory analysis for liver functions and measuring blood pressure.
Main Outcome Measures: Subjective data regarding safety and efficacy were assessed from the
validated questionnaire. Blood pressure was measured. Blood samples were collected to assess the
drug/adulterants concentration and liver and kidney functions.
Results: All tested nutraceuticals showed undeclared Sildenafil citrate in patients. Questionnaire
results showed high inter-patient variability with respect to efficacy and comparable safety profile
compared to Viagra®.
Conclusion: The validated tailored-designed questionnaire effectively assessed the efficacy and safety
of male enhancement products. The male enhancement nutraceuticals, sold in Egypt, claimed to be
100% natural are adulterated and of questionable safety profile.
