Objective: to compare the acceptability of a new estradiol gel TX 11323 (A) and a transdermal matrix system.
Method: this randomised open crossed study was conducted on 80 healthy menopausal female volunteers treated successively with 1.5 mg of estradiol per day in gel form (Estreva Gel, Theramex, Monaco) and by a transdermal matrix twice-weekly system delivering 50 micrograms/24 h of estradiol (Oesclim 50, Fournier, Dijon-France). The treatment was applied for 25 days with an interval of 6 days between the 2 administration cycles. Acceptability was evaluated and compared by a self-questionnaire given on D1 and D25 of each therapeutic cycle.
Results: the 2 treatments, after 25 days of use, were judged convenient, easy and fast to use by more than 90% of subjects. There was, nevertheless, a significant difference in favour of the gel in respect of the estimation of the "visual aspect" of the treatment, reported skin problems, problems with application technique, as well as discomfort during intimacy found in 11% of cases using the transdermal system. It is noted that 80% of the women consider the gel treatment more feminine (p < 0.001) and that 61.3% prefer this treatment compared to 32.5% preferring the transdermal system studied (p = 0.005).
Conclusion: this study shows a better acceptability of the estradiol gel TX 11323 (A) compared to that of the transdermal matrix system studied.