Ospemifene Improves Clinical Signs of Vaginal Atrophy: Presented at NAMS

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Title: Ospemifene Improves Clinical Signs of Vaginal Atrophy: Presented at NAMS
URL: http://www.pslgroup.com/dg/22DD3A.htm
Doctor's Guide
September 29, 2008

By Deborah Brauser

ORLANDO, Fla -- September 29, 2008 -- Ospemifene, a selective oestrogen receptor modulator (SERM), significantly relieves multiple symptoms of vulvovaginal atrophy (VVA) in postmenopausal women, according to research presented here at the North American Menopause Society (NAMS) 19th Annual Meeting.

Lead investigator David Portman, MD, Columbus Center for Women's Health Research, Columbus, Ohio, reported the results here in a clinical poster session on September 25.

"The most exciting aspect of this study is that very few, if any, SERMs have been shown to be beneficial in the lower reproductive tract on vaginal mucosa," said Dr. Portman. He went on to say that this does not appear to be the case with ospemifene. "This may be a SERM [that is] unique in that it will help treat vaginal dryness and pain with intercourse. In this particular setting, the clinician actually saw tangible improvement on exam -- most notably on appearance of dryness. And pale tissue improved markedly during the 12 weeks of study."

In this multicentre, double-blind, parallel-group, phase 3 study, a total of 826 postmenopausal women with moderate to severe symptoms of VVA were randomised to receive 30 or 60 mg/day of ospemifene or placebo orally. The subjects ranged in age from 40 to 80 years.

The clinical signs of VVA -- petechiae, pallor, friability, vaginal dryness in mucosa, and vaginal redness in mucosa -- were assessed in all groups by a visual evaluation during a gynaecological examination at baseline, week 4, and week 12. During the visual assessments, the severity of each clinical sign was graded from 0 to 3 (0 = none, 1 = mild, 2 = moderate, and 3 = severe). The change from baseline (each active arm vs placebo) at weeks 4 and 12 was analysed using a stratified Cochran-Mantel-Haenszel row mean score test.

At baseline, the mean severity scores for the VVA signs were 1.89 for vaginal dryness in mucosa, 1.69 for pallor, 1.11 for vaginal redness in mucosa, 0.96 for friability, and 0.88 for petechiae.

Subjects with complete data at each time point (n = 615) were included in the final analysis.

The positive effects of ospemifene became apparent at week 4, as the mean scores for vaginal dryness in mucosa, pallor, and friability were significantly decreased (P < .0001 for both doses versus placebo). The vaginal redness in mucosa was also significantly decreased in the 60-mg group (P = .01 vs placebo).

The only symptom that did not reach statistical significance was vaginal redness in mucosa at 4 weeks with the 30-mg dose.

After 12 weeks of treatment, the mean scores for all clinical signs were significantly decreased in both dosage groups when compared to the placebo group (P < .05 for vaginal redness at 30 mg and P < .001 for all other clinical signs for the change from baseline vs placebo). In addition, the percentage of subjects that had a change from moderate-to-severe to none or from moderate-to-severe to none/mild at week 12 was significantly higher in both ospemifene groups when compared with the placebo group (except for the change to none in redness in the 30-mg dose.)

"I think [the outcome] was a little bit surprising. We had a signal that it was going to be beneficial, but these results were pretty close to what you may even see with an estrogen, so that was impressive," concluded Dr. Portman. "It's also nice from a clinician's standpoint to see visible signs of the patient's benefit."

Overall, Dr. Portman says ospemifene appears promising for symptomatic postmenopausal women: "Hopefully it will be another option for patients … who are suffering from a pretty common condition and who can't, or won't, take traditional estrogen therapy."

Funding for this trial was provided by QuatRx Pharmaceuticals Company.

[Presentation tile: Ospemifene Improves the Clinical Signs of Vaginal Atrophy: Results From a Pivotal Phase 3 Study. Abstract P-48]

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