[Comparative evaluation of the acceptability of a new estradiol gel TX11323(A) and a reference gel]

This randomized, crossed, single-blind study compared the acceptability and drying time of the new estradiol gel TX11323(A) (Estréva Gel, Laboratoire Théramex) to that of a reference gel (CEstrodose, Laboratories Besins-Iscovesco), in two phases. In phase 1, 48 healthy menopausal female volunteers applied 1.5 mg estradiol of each form of estradiol gel on the outer side of the arm for 8 days, with a free period of 7 days between the two treatments. Acceptability, evaluated by self-questionnaire and drying time for the two treatments were noted at day 1 and day 8. The second phase applied only to 16 subjects who followed the same therapeutic protocol, except that this time application was made on the antero-external side of the thighs. Only the subjectively and objectively quantified drying-time was taken into account. A significant difference was found in favor of TX11323(A) gel in terms of the following items: consistency, ease of application and penetration, quantity of gel to apply, sensation of lasting stickness. We note that 68.8% subjects prefer TX11323(A) gel and 27.1% prefer the reference gel (p = 0.001). The timed drying-time for TX11323(A) gel is significantly reduced, 40 to 50% on average depending on the phase, compared to that of the reference gel. The subjective evaluation of the subjects confirms this shorter drying time.