Ultra-Low-Dose Oestradiol Vaginal Tablet Provides Sustained Improvement of Vaginal-Atrophy Symptoms: Presented at NAMS

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Title: Ultra-Low-Dose Oestradiol Vaginal Tablet Provides Sustained Improvement of Vaginal-Atrophy Symptoms: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DE7E.htm
Doctor's Guide
September 30, 2008

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)

· Significant improvement (P < .001) in vaginal health grade from baseline at weeks 4, 8, and 12, and sustained by week 52 at all timepoints

· Significant decreases in vaginal pH to <5.5 in 71% of the subjects at week 12 (vs 36% with placebo) and in 65% of the subjects at week 52 (vs 29% with placebo)

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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