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Title: Low-Dose Oestradiol Tablets Decrease Vaginal Atrophy in Postmenopausal Women: Presented at ASRM

"Low-Dose Oestradiol Tablets Decrease Vaginal Atrophy in Postmenopausal Women: Presented at ASRM"

By Arushi Sinha SAN FRANCISCO -- November 13, 2008 -- As a result of menopause, many women take hormonal therapies to alleviate some of the uncomfortable urogenital symptoms. New research presented at the American Society for Reproductive Medicine (ASRM) 64th Annual Meeting examined the effectiveness of a lower-dose oestradiol therapy in postmenopausal women. "The goal of the research was to see if a really low dose was as effective as the typical larger dose," explained Lila Nachtigall, MD, Department of Obstetrics and Gynecology, New York University School of Medicine, New York, New York, who presented the findings on November 10 on behalf of the research team. The study analysed the effect on vaginal atrophy after administration of 17b-oestradiol (E2) 10 mcg vaginal tablets. In the 52-week, randomised, double-blind, multicentre, placebo-controlled study, 309 postmenopausal women were randomised in a 2:1 ratio to oestradiol 10 mcg or placebo administered vaginally once-daily. Treatment was administered once daily for 2 weeks and then twice weekly for the remainder of the study. Patients were at least 45 years of age, had not undergone hysterectomy, and were at least 2 years past menopause. At baseline, patients in the oestradiol and placebo groups reported discomfort during sexual intercourse (52.5% vs 60.8%, respectively), vaginal dryness (28.4% and 26.5%, respectively), and itching or irritation (12.3% and 9.8%, respectively). Results demonstrated that the low-dose regimen provided significant improvement for the most bothersome symptoms compared with placebo at weeks 8 ([P = .014) and 12 (P = .003), as well as at 1 year (P = .004).

In addition, the researchers found improvement in vaginal pH compared with placebo (P < .001).

Based on these results, the researchers concluded that an ultra-low dose of oestradiol provides symptomatic relief from postmenopausal symptoms.

Dr. Nachtigall noted that the low-dose formulation may provide a good solution for women who are concerned about additional hormone therapy, such as women with history of cancer. "This has been an effective therapy for a large variety of patient groups," she said.

Funding for this research was provided by Novo Nordisk A/S.

[Presentation title: An Ultra-Low Dose (10 mcg) Estradiol Vaginal Tablet Improves Signs and Symptoms Associated With Vaginal Atrophy. Abstract P-426]

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