Shionogi Inc. has initiated a phase 3 clinical trial to evaluate the safety and efficacy of Osphena (ospemifene) for the treatment of moderate to severe vaginal dryness, a symptom of vulvovaginal atrophy (VVA), due to menopause.

"Vaginal dryness is one of the most common and uncomfortable symptoms of VVA experienced by postmenopausal women," said Juan Camilo Arjona Ferreira, MD, senior vice president, clinical development. "We look forward to the results of this study and the potential to offer the women who suffer from this condition an oral, non-hormonal treatment option."  

Osphena is FDA approved for the treatment of moderate to severe painful sex known as dyspareunia, a symptom of VVA due to menopause.

The randomized, double-blind, placebo-controlled multicenter study will assess the safety and efficacy of Osphena 60 milligrams (mg) once-daily oral therapy in postmenopausal women with vaginal dryness as the most bothersome symptom (MBS) of VVA due to menopause. About 600 postmenopausal women between the ages of 40 and 80 will be randomized in a 1:1 ratio to treatment with Osphena or placebo. Safety and efficacy will be assessed at 12 weeks, and study participants will be followed for two years.

Vaginal dryness is one of the most prominent symptoms of VVA, which is caused by declining estrogen levels during menopause and results in the thinning and inflammation of the vaginal walls. The prevalence of VVA among postmenopausal women is nearly 50 per cent.

Shionogi Inc. is the US-based subsidiary of Shionogi & Co., Ltd., a Japanese pharmaceutical company with a 137-year history discovering and developing innovative therapies.