Ospemifene for the treatment of menopausal vaginal dryness, a symptom of the genitourinary syndrome of menopause Original paper

What was studied?

This article reviews the efficacy and safety of ospemifene for treating menopausal vaginal dryness, a symptom of the genitourinary syndrome of menopause (GSM). Ospemifene, a selective estrogen receptor modulator (SERM), has been shown to improve vaginal atrophy symptoms, particularly dryness and dyspareunia, in postmenopausal women. The article also highlights the benefits of ospemifene over other treatment options, including vaginal estrogen therapies and non-hormonal lubricants. Ospemifene’s role in improving the quality of life for women suffering from GSM symptoms is examined, focusing on its impact on vaginal pH, cell composition, and sexual function.

Who was studied?

The study involved postmenopausal women suffering from moderate to severe symptoms of vulvovaginal atrophy (VVA) as part of the broader genitourinary syndrome of menopause (GSM). Participants were typically aged between 50 and 65 years and were recruited for several clinical trials. Women who participated in the studies had reported moderate to severe vaginal dryness, discomfort, and dyspareunia, all of which are prevalent symptoms of VVA. The study population included those with or without a uterus, and the trials focused on the safety and efficacy of ospemifene in improving these symptoms. The trials also included a variety of demographic factors such as body mass index (BMI) and hormonal therapy use.

Most important findings

The clinical trials assessed ospemifene’s effects on several key symptoms of VVA, including vaginal dryness and dyspareunia. In the studies, ospemifene at doses of 60 mg daily demonstrated significant improvement in vaginal moisture and reduction in vaginal pH, which is often elevated in VVA. The treatment led to a dose-dependent increase in superficial vaginal epithelial cells and a reduction in parabasal cells, indicating a positive impact on vaginal health. Compared to placebo, ospemifene was found to significantly alleviate symptoms of vaginal dryness and dyspareunia, with patients reporting a marked improvement in sexual function, measured using the Female Sexual Function Index (FSFI). The most common side effects associated with ospemifene included hot flashes and urinary tract infections, but these were reported at lower frequencies than in placebo-treated groups.

Key implications

Ospemifene presents a promising alternative to traditional estrogen therapies for managing VVA in postmenopausal women, especially for those unable to use systemic or vaginal estrogen due to contraindications like breast cancer. This SERM offers localized treatment that targets the vaginal epithelium without significantly affecting systemic estrogen levels, making it a safer option for many women. Its efficacy in improving both objective and subjective measures of vaginal health is a significant advantage over non-hormonal therapies, such as moisturizers, which only offer temporary symptom relief. Given its favorable safety profile, including the absence of endometrial or breast cancer risks, ospemifene could become a standard treatment option for women with GSM symptoms, improving their quality of life. However, further studies examining the long-term effects and safety of ospemifene are necessary, particularly in populations with varying medical histories.