Abstract
The objective of this 12-week, open-label, randomized, parallel, multicenter study was to compare the efficacy, safety, and patient acceptance of an estradiol-releasing vaginal ring (Estring) and a vaginal estrogen cream (Premarin) for relieving signs and symptoms of urogenital atrophy in postmenopausal women. Improvement in signs and symptoms of urogenital atrophy, the frequency of endometrial stimulation, and patient ratings of the product were evaluated. The progestogen challenge test, pelvic sonography, vaginal cytology for maturation index, and an endometrial biopsy were also assessed. Of 192 subjects included in the efficacy and safety analysis, 173 (113 on the vaginal ring; 60 on the vaginal cream) completed the 12-week treatment period. Both treatments were equivalent for improvement in vaginal maturation index, and physician's and subject's overall assessments. The incidence of endometrial stimulation and adverse events was comparable between treatment groups, but subjects gave excellent ratings for patient acceptance to the vaginal ring significantly more often than to the vaginal cream. The results from this study indicate that a low-dose estrogen vaginal ring and a vaginal cream are comparable for efficacy and safety, but the vaginal ring was given a higher percentage of excellent ratings for patient acceptance.