A prospective randomized comparative study of the effects of intranasal and transdermal 17 beta-estradiol on postmenopausal symptoms and vaginal cytology.

ABSTRACT

CONTEXT Investigating the adverse effects of oral hormone replacement therapy (HRT), the clinical effectiveness of alternative combinations and route of administrations. AIM: To compare the effects of intranasal and transdermal 17 beta-estradiol combined with vaginal progesterone on vasomotor symptoms and vaginal cytology. SETTINGS AND DESIGN: A 12-week, prospective, randomized comparative study was conducted between July 2005 and September 2006. MATERIALS AND METHODS: Eighty postmenopausal women aged between 42-57 years, who had scores of > or =1.7 on the menopause rating scale-I (MRS-I) items "1-6", were randomly assigned to receive intranasal (300 microg/day, n =40) or transdermal (50 microg/day, n =40) 17 beta-estradiol continuously. All patients also received a vaginal progesterone gel twice weekly. Vasomotor symptoms were evaluated at weeks 0, 4, 8 and 12. Vaginal maturation index (VMI) was evaluated at weeks 0 and 12 of the study. STATISTICAL ANALYSES The Mann-Whitney U and the Wilcoxon tests were used. P < 0.05 was regarded as significant. RESULTS: Thirty-two women in the intranasal and 29 women in the transdermal group completed the study. The total score of the MRS, the sum-scores of Factor 1 "HOT FLUSHES" and Factor 2 "PSYCHE" significantly decreased in both groups at week 4. Factor 3 "ATROPHY" scores significantly decreased only in the transdermal group at week 12. The VMI showed no changes within and between the two groups at the end of the study. CONCLUSION: Intranasal and transdermal 17beta-estradiol combined with vaginal progesterone gel as a continuous HRT caused a similar decrease in vasomotor symptoms but did not have any significant effect on VMI after 12 weeks of treatment in this study population.