Ospemifene improved common, bothersome vaginal atrophy in postmenopausal women

Issue: October 2008

NAMS 19th Annual Scientific Meeting

New data presented at the North American Menopause Society 19th Annual Scientific Meeting report a high prevalence of vaginal atrophy, and clinical trial results suggest ospemifene may improve this condition.

QuatRx conducted a survey to evaluate the prevalence and impact of vaginal atrophy symptoms and perceptions about the safety of estrogen treatment among postmenopausal women. Of 2,290 respondents — both sexually active and non-sexually active women — 45% reported symptoms of vulvovaginal atrophy. The most common clinical signs reported were vaginal discomfort, such as dryness, pain, irritation and itching.

“Many women have vaginal atrophy symptoms in the absence of sexual activity, so it’s not all about uncomfortable intercourse,” researcher Nanette Santoro, MD, director of the Division of Reproductive Endocrinology and Fertility at Albert Einstein College of Medicine and Montefiore Medical Center in New York, told Endocrine Today.

Seventy percent of women reported using estrogen for more than five years. Estrogen-related safety concerns were the main reason for discontinuation or never use among the majority of respondents; yet, the prevalence of vaginal atrophy was highest among women who never used estrogen or discontinued use. Of the women who had never used hormone therapy, 26% assumed their symptoms would subside over time.

Ospemifene phase-3 data

In an unrelated study, QuatRx presented phase-3 results on ospemifene tablets (Ophena) for the treatment of vulvovaginal atrophy in postmenopausal women. The multi-center, double-blind, placebo-controlled study enrolled 826 women at 80 U.S. centers.

Results demonstrated that 12 weeks of treatment with ospemifene significantly improved vulvovaginal atrophy symptoms, including petechiae, pallor, friability and vaginal dryness, compared with placebo. The positive effects were reported as early as week four. Those patients who received ospemifene experienced greater decreases from baseline in mean scores for vaginal dryness in mucosa, pallor and friability, compared with placebo (P<.001) Treatment was generally well tolerated and demonstrated a favorable safety profile.

“In the clinical trial, ospemifene, an estrogen receptor-beta agonist that has minimal to no estrogen receptor-alpha activity, was highly effective. So, scientifically, this tells us that women, similar to other animals, have plentiful estrogen receptor-beta receptors in their vulvovaginal tissues and that ligands that are selective for their estrogen receptor-beta activity have the potential to treat vaginal symptoms without many of the unwanted systemic side effects of estradiol, which are due to its activation of estrogen receptor-alpha,” said Santoro, who was not a researcher for this trial.

Earlier this year, QuatRx announced that a phase-3 study for ospemifene met all four of its co-primary endpoints and showed statistically significant improvements in vaginal dryness and dyspareunia. – by Katie Kalvaitis

For more information:

Portman D and Komi J. #P-48.

Santoro N and Komi J. #P-51. Both presented at: North American Menopause Society 19th Annual Scientific Meeting; Sept. 24-27, 2008; Orlando.