Unlike topical testosterone preparations, Androxal maintains the normal daily rhythm of testicular testosterone production with peak levels generally occurring in the morning and trough levels exhibited in the evening. The testosterone levels achieved by the administration of topical preparations are a function of a variety of factors none of which relate to the normal daily rhythm. In some instances, subject to subject variability can lead to supernormal levels of testosterone several hours after administration of the topical preparations. The Company has committed to conduct one additional 24 hour study to show that Androxal’s action in maintaining the normal rhythm is both predictable and dose dependent.
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