OBJECTIVE: To evaluate the efficacy of two vaginal doses of estradiol (E2) compared with placebo in the treatment of atrophic vaginitis. METHODS: In a multi-center, randomized, double-blind, parallel-group study, 230 postmenopausal women receivedtreatment with 25 mcg or 10 mcg E2 or placebo for 12 weeks. Efficacy was measured through composite score of three vaginal symptoms and grading of vaginal health. Additional analyses included maturation of vaginal and urethral mucosa. Safety assessments included endometrial biopsy, adverse events, changes in laboratory tests, and physical examinations. After 12 weeks of treatment, all patients were switched to the open-label extension and received treatment with 25 mcg E2 up to week 52. RESULTS: Vaginal tablets with 25 mcg and 10 mcg E2 showed significant (P<.001) improvement in composite score of vaginal health. Other results with 10 mcg E2 were not entirely consistent with those for 25 mcg E2. Over 12 weeks, both active treatments resulted in greater decreases in vaginal pH than placebo. There were no significant differences between the 25 mcg and 10 mcg E2 groups in terms of improvements in maturation value or composite score of three vaginal symptoms. The efficacy was maintained to week 52 with 25 mcg E2. CONCLUSION: Vaginal tablets with 25 mcg and 10 mcg E2 provided relief of vaginal symptoms, improved urogenital atrophy, decreased vaginal pH, and increased maturation of the vaginal and urethral epithelium. Those improvements were greater with 25 mcg than with 10 mcg E2. Both doses were effective in the treatment of atrophic vaginitis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00465192 and NCT00464971 LEVEL OF EVIDENCE: I.
RCT Entities:
OBJECTIVE: To evaluate the efficacy of two vaginal doses of estradiol (E2) compared with placebo in the treatment of atrophic vaginitis. METHODS: In a multi-center, randomized, double-blind, parallel-group study, 230 postmenopausal women received treatment with 25 mcg or 10 mcg E2 or placebo for 12 weeks. Efficacy was measured through composite score of three vaginal symptoms and grading of vaginal health. Additional analyses included maturation of vaginal and urethral mucosa. Safety assessments included endometrial biopsy, adverse events, changes in laboratory tests, and physical examinations. After 12 weeks of treatment, all patients were switched to the open-label extension and received treatment with 25 mcg E2 up to week 52. RESULTS: Vaginal tablets with 25 mcg and 10 mcg E2 showed significant (P<.001) improvement in composite score of vaginal health. Other results with 10 mcg E2 were not entirely consistent with those for 25 mcg E2. Over 12 weeks, both active treatments resulted in greater decreases in vaginal pH than placebo. There were no significant differences between the 25 mcg and 10 mcg E2 groups in terms of improvements in maturation value or composite score of three vaginal symptoms. The efficacy was maintained to week 52 with 25 mcg E2. CONCLUSION: Vaginal tablets with 25 mcg and 10 mcg E2 provided relief of vaginal symptoms, improved urogenital atrophy, decreased vaginal pH, and increased maturation of the vaginal and urethral epithelium. Those improvements were greater with 25 mcg than with 10 mcg E2. Both doses were effective in the treatment of atrophic vaginitis. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00465192 and NCT00464971 LEVEL OF EVIDENCE: I.
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