Ospemifene May Be Safe, Effective for Vulvovaginal Atrophy

Laurie Barclay, MD

May 12, 2010

May 12, 2010 — Ospemifene is well tolerated and effective for the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy (VVA), over and above the use of provided lubricants, according to the results of a randomized, double-blind phase 3 study reported in the May/June issue of Menopause.

"[V]aginal estrogen therapy products may cause systemic absorption and systemic estrogenic effects, which have led to the development of vaginal regimens that contain lower doses of estrogen," write Gloria A. Bachmann, MD, from the Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey in New Brunswick, and colleagues from the Ospemifene Study Group. "Another treatment option for VVA may be a selective estrogen receptor modulator (SERM), such as ospemifene....The aim of this study was to study the efficacy and safety of ospemifene, a new selective estrogen receptor modulator, in the treatment of vulvovaginal atrophy in postmenopausal women."

For 12 weeks, 826 postmenopausal women were assigned 1:1:1 to orally administered treatment with ospemifene 30 or 60 mg/day or placebo. Inclusion criteria were 5% or less superficial cells on the vaginal smear for maturation index, a vaginal pH of more than 5.0, and 1 or more moderate or severe symptoms of VVA. All women received a nonhormonal vaginal lubricant to use as needed.

Primary endpoints were the change in the percentage of superficial and parabasal cells on the vaginal smear, change in vaginal pH, and change in severity of vaginal dryness or dyspareunia (whichever was the most bothersome symptom) from baseline to 12 weeks vs placebo.

For the 60-mg dose of ospemifene, each of the coprimary endpoints was statistically significantly superior to placebo. Except for dyspareunia, all coprimary endpoints were statistically significantly superior with the 30-mg dose vs placebo. At both doses, ospemifene was well tolerated and safety profile was favorable.

"Ospemifene was shown to be effective and well tolerated for the treatment of the symptoms of vaginal dryness and dyspareunia associated with vulvovaginal atrophy over and above the use of provided lubricants," the study authors write.

Limitations of this study include lubricant freely provided to all study groups, which created challenges regarding the estimation of the treatment effect and the sample size calculations.

In an accompanying editorial, Lee P. Shulman, MD, from Feinberg School of Medicine at Northwestern University in Chicago, Illinois, called ospemifene "a potentially important clinical advancement in acceptable therapeutic options for VVA and menopausal management in general."

"The availability of an effective and safe nonestrogenic- and nonlubricant-based therapy may increase the recognition among women and their clinicians that VVA is a condition that warrants diagnosis and intervention and increase the use of effective therapeutic interventions in symptomatic women," Dr. Shulman writes. "Improving the lives of postmenopausal women is an integral part of the professional lives of the readers of Menopause; in this regard, the demonstration of the effectiveness and safety of a nonestrogenic and nonlubricant therapy for VVA may facilitate the diagnosis of and encourage treatment for VVA, thus providing us with more tools to improve the lives of women during menopause."

QuatRx Pharmaceuticals has funded this study, employs coauthor Janne O. Komi, MD, PhD, and has compensated Dr. Bachmann for her activity as an investigator in the study. Dr. Shulman has disclosed no relevant financial relationships.

Menopause. 2010;17:452-453, 480-486.


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