OBJECTIVES

: Genitourinary syndrome of menopause (GSM) is a chronic, progressive condition affecting up to 60% of post-menopausal women in the United States. Dyspareunia, or pain with sexual intercourse, has been recognized as one of GSM’s most bothersome symptoms. Despite high prevalence and availability of treatments, many women are not adequately managed, and unmet need remains. The objective of this systematic literature review was to characterize the unmet need.

METHODS

: A systematic PubMed search for studies focusing on unmet need, efficacy, and safety of GSM treatments published from 2013-2018 was conducted using the PRISMA guidelines. Identified abstracts were scored by two independent reviewers to assess eligibility for inclusion. This yielded 116 full-text articles meeting the final inclusion criteria.

RESULTS

: Clinical guidelines recommend a step-wise approach to GSM management, utilizing over the counter (OTC) products as first-line therapies followed by prescription therapies as indicated for persistent symptoms. These products consist of systemic and vaginal estrogens, prasterone or synthetic dehydroepiandrosterone (DHEA), and an oral selective estrogen receptor modulator (SERM), with systemic estrogen therapy generally reserved for women with concomitant vasomotor symptoms. Studies have shown that OTC treatments provide only temporary symptomatic relief. Further, all estrogen products and SERMs have class-effect boxed warnings for endometrial cancer and adverse cardiovascular outcomes, causing reluctance among women and healthcare professionals (HCPs) to use these products. Given that GSM is a chronic condition requiring long-term treatment, many women and HCPs have safety concerns even with vaginal estrogens. Prasterone, a non-estrogen vaginal insert, does not carry a boxed warning and has demonstrated efficacy in moderate to severe dyspareunia due to menopause.

CONCLUSIONS

: Despite availability of multiple treatments for GSM, unmet need remains. Non-estrogen prasterone addresses both medical needs and safety concerns of HCPs and women suffering from moderate to severe dyspareunia associated with GSM.