Comparison of Alora estradiol matrix transdermal delivery system with oral conjugated equine estrogen therapy in relieving menopausal symptoms. Alora Study Group.

OBJECTIVE

To compare the efficacy of two strengths of an estradiol matrix transdermal delivery system with daily oral doses of conjugated equine estrogens in reducing the frequency of moderate-to-severe hot flushes in postmenopausal women.

DESIGN

The design of the study provided for the following treatment regimens: an estradiol transdermal delivery system (Alora 0.05 or 0.1 mg/day) administered twice weekly or oral doses of conjugated equine estrogens (CEE 0.625 or 1.25 mg) administered daily were given to 321 highly symptomatic postmenopausal women for 12 weeks following a randomized, parallel-group, double-blind, double-dummy design.

RESULTS

Results indicate no statistically significant differences at any time point in mean frequency or mean percentage reduction in frequency of moderate-to-severe hot flushes between patients given Alora 0.1 mg/day and those receiving CEE 1.25 mg/day. Similarly, no significant differences were observed at any time in mean frequency of moderate-to-severe hot flushes between the Alora 0.05 mg/day and CEE 0.625 mg/day groups, although the group receiving CEE 0.625 mg/day exhibited a statistically greater percentage reduction than the Alora 0.05 mg/day group at weeks 3, 4 and 8. By week 12, these two treatments were statistically indistinguishable. There were no serious or unexpected adverse events with the two transdermal systems and local skin tolerability was excellent. Other estrogenic effects such as restoration of vaginal cytology, breast tenderness and unexpected vaginal bleeding were comparable between transdermal and oral administration groups except for a lower incidence of bleeding in those women receiving the lower dose transdermal regimen.