The results showed that Ophena significantly improved a broad range of clinical signs of vulvovaginal atrophy (VVA), including petechiae, pallor, friability, vaginal dryness and redness in mucosa. These are all visual observations of VVA assessed during gynecological examination and were pre-defined secondary endpoints in the study.
Earlier in 2008, QuatRx announced a Phase III study for Ophena met all four of its co-primary endpoints. The results of the study showed statistically significant improvements in vaginal dryness and dyspareunia (painful intercourse), two of the most bothersome symptoms associated with VVA. The study also demonstrated favorable effects of Ophena on vaginal wall health as compared to placebo, measured as changes in the proportion of parabasal and superficial cells in the vaginal epithelium, as well as a favorable effect on vaginal pH levels.
The multi-center, double-blind, placebo-controlled study was conducted at 80 US centers and involved 826 postmenopausal women. The additional results showed that after 12 weeks of treatment, the mean scores for common clinical signs of vaginal atrophy were decreased by a statistically significant margin in the Ophena groups when compared with placebo.
These positive effects of Ophena were already evident at week four, as the mean scores of all signs were significantly decreased by Ophena when compared to placebo. Ophena was generally well tolerated and demonstrated a favorable safety profile in this study.
David Portman, director of the Columbus Center for Women’s Health Research in Ohio, said: “These results show that Ophena has the potential to significantly improve multiple clinical signs of vaginal atrophy in symptomatic patients. These are significant results for a non-estrogen oral therapy and may pave the way for an alternative approach to a very common and concerning condition for postmenopausal women.”