Objective: 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.
Methods: A randomized, double-blind phase 3 study in which 826 postmenopausal women were randomized 1:1:1 to receive treatment with ospemifene 30 or 60 mg/day or placebo orally for 12 weeks was conducted. The primary inclusion criteria were having 5% or less superficial cells on the vaginal smear (maturation index), vaginal pH greater than 5.0, and at least one moderate or severe symptom of vulvovaginal atrophy. The four coprimary endpoints were the change from baseline to 12 weeks in the percentage of superficial and parabasal cells on the vaginal smear, change in vaginal pH, and change in severity of most bothersome symptom (vaginal dryness or dyspareunia) compared with placebo. All participants were given a nonhormonal vaginal lubricant for use as needed.
Results: Ospemifene was statistically significantly superior to placebo in each of the coprimary endpoints at the 60-mg dose. Statistically significant results were achieved for all coprimary endpoints with the 30-mg dose except for dyspareunia. Ospemifene was well tolerated at both doses and demonstrated a favorable safety profile.
Conclusions: 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.
This pivotal phase 3 study demonstrates that ospemifene is effective in treating both subjective measures (symptom relief) and objective measures (maturation index and vaginal pH) of vulvovaginal atrophy in postmenopausal women. The positive effect of ospemifene is demonstrated over and above the use of provided vaginal lubricants.
From the 1Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, New Brunswick, NJ; and 2QuatRx Pharmaceuticals Company, Ann Arbor, MI.
Received July 2, 2009; revised and accepted September 17, 2009.
Funding/support: This study was funded by QuatRx Pharmaceuticals Company.
Financial disclosure/conflicts of interest: Dr. Bachmann received compensation for her activity as an investigator in the study.
Address correspondence to: Gloria A. Bachmann, MD, Robert Wood Johnson Medical School, University of Medicine and Dentistry of New Jersey, Clinical Academic Building, 125 Paterson St., New Brunswick, NJ 08901. E-mail: firstname.lastname@example.org