Comparison of the efficacy and tolerability of a new once-a-week matricial estradiol transdermal system (Estrapatch 40 and Estrapatch 60) with a twice week system.
OBJECTIVE
To compare the efficacy and tolerability of three transdermal systems (Estrapatch 40, Estrapatch 60 and Oesclim 50).


METHODS
Multicentre, randomized, open, 3 parallel group study on 421 postmenopausal women presenting with at least 35 hot flushes in the week preceding inclusion and treated for six 28-day cycles with either Estrapatch 40 (n = 141) or Estrapatch 60 (n = 140) once a week or Oesclim 50 (n = 140) twice a week, associated to oral NETA (Millligynon 2x 0.6 mg tablets daily) from day 15 to day 28. Hot flushes, mastodynia, bleeding, local skin tolerability and adhesiveness were reported on daily cards. Endometrial thickness and estrogens were measured before and after treatment.


RESULTS
Efficacy was clearly established for the three devices as early as after one cycle of treatment, with success rates (% of women with a decrease > or = 50% of the number of hot flushes) over 97% from cycle 2. The three treatments were equivalent on this criteria, except at cycle 1 for Estrapatch 40 which was not equivalent to both other treatments. Incidence and severity of mastodynia, bleeding pattern, endometrial thickness and specific estrogen-related adverse events reflected a significant higher estrogenic stimulation with Oesclim 50. Adhesiveness was very satisfactory for the three systems.


CONCLUSIONS
Estrapatch 40 and 60 presents a better benefit/risk ratio compared to Oesclim 50. Thus Estrapach 40 appears to be a good choice for a first-line estrogen replacement therapy with the possibility to increase the dose to Estrapatch 60.
Raynaud
Jean-Pierre
JP
Université Pierre and Marie Curie, DRI, 4 place Jussieu, 75252 Paris Cedex 05, France. jean-pierre.raynaud@admp6.jussieu.fr
Lévrier
Marc
M
Calaf
Joaquim
J
Laur
Clément
C
Pélissier
Clara
C
D000279:Administration, Cutaneous; D000328:Adult; D000368:Aged; D004334:Drug Administration Schedule; D004717:Endometrium / Q000187:drug effects / Q000473:pathology; D004890:Erythema / Q000139:chemically induced; D004958:Estradiol / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D004970:Estrone / Q000097:blood; D005260:Female; D019584:Hot Flashes / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D008055:Lipids / Q000097:blood; D008875:Middle Aged; D012449:Safety; D014592:Uterine Hemorrhage / Q000139:chemically induced
D008055:Lipids; D004970:Estrone; D004958:Estradiol