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| |  Ultra-Low-Dose Oestradiol Vaginal Tablet Provides Sustained Improvement of Vaginal-Atrophy Symptoms: Presented at NAMS By Deborah Brauser ORLANDO, Fla -- September 30, 2008 -- An ultra-low dose 17B-oestradiol vaginal tablet is safe, well-tolerated, and provides significant sustained improvements in postmenopausal women with urogenital symptoms associated with oestrogen deficiency-induced vaginal atrophy, according to results from a trial presented here at the North American Menopause Society (NAMS) 19th Annual Meeting. James Simon, MD, Women's Health & Research Consultants, Washington, DC, presented the results of a 1-year, phase 3 study in a poster session here on September 25. He said the objective of the trial was to evaluate the efficacy and safety of a very low dose (10 mcg) of oestradiol vaginal tablet during treatment. A 25-mcg oestradiol vaginal tablet is currently indicated for the treatment of vaginal atrophy.(1) In the multicentre, double-blind, parallel-group trial, 309 postmenopausal women aged 45 years or older with signs of vaginal atrophy were randomly assigned 2:1 to receive a 10-mcg oestradiol vaginal tablet or placebo vaginal tablet once daily for 2 weeks, and then twice weekly for the remainder of the study. Efficacy assessments included vaginal cytology, grading of vaginal health, vaginal pH, and rating of a patient's "most bothersome" moderate or severe urogenital symptom. Safety assessments included endometrial biopsy results, physical and gynaecological examinations, and adverse-event monitoring. Results after only 2 weeks of treatment with the 10-mcg oestradiol tablet demonstrated increases of 24% versus placebo (P < .001) from baseline in the proportion of vaginal superficial cells and 15% versus placebo (P = .007) in the proportion of intermediate cells, with the proportion of vaginal parabasal cells decreasing from baseline by 39% versus placebo (P < .001). In addition, compared with placebo, the 10-mcg oestradiol treatment group demonstrated the following: · Significant improvements in vaginal Maturation Index and Maturation Value at weeks 2, 4, 8, 12, and 52 (indicating clinically relevant improvement in vaginal cytology towards a more premenopausal epithelium) Finally, there was a significant difference favouring the 10-mcg dose of oestradiol at weeks 8, 12, and 52 in the decrease from baseline in "most bothersome" urogenital-symptom mean score. Results from the safety assessments showed that the proportion of subjects reporting adverse events and serious adverse events was similar between trial groups, with 5 subjects reporting 6 serious adverse events in the 10-mcg oestradiol treatment group versus 2 subjects reporting 3 serious adverse events in the placebo group. No other clinically relevant findings were found regarding physical, gynaecological, or laboratory assessments. "Looking at the results from our year-long study, we had very good long-term safety," noted Dr. Simon. "The safety data going out to 52 weeks is … very important. I was also happy that patients' most bothersome symptom was relieved significantly with this product." "In studying this low-dose version, we found it very effective for all the symptoms and intermediate biomarkers that we [examined]," Dr. Simon concluded. "It was an opportunity to reduce the dose, with the presumption of better safety -- especially since people want the lowest dose in the shortest time for vulvovaginal atrophy." Funding for this trial was provided by Novo Nordisk Inc. 1. Bacman G et al. Obstet Gynecol. 2008;111:67-76.
[Presentation title: An Ultra-Low Dose (10 mcg) Oestradiol Vaginal Tablet Is Safe and Effective for the Treatment of Vaginal Atrophy in Post-Menopausal Women. Abstract P-56]
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