Genitourinary syndrome of menopause

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TABLE 2

FDA-approved labeling notes for treatments for genitourinary syndrome of menopause

Products	GSM indications	Breast cancer effects
Estrogen products
17-beta estradiol vaginal cream (Estrace)	Moderate to severe vulvar and vaginal atrophy due to menopause	All estrogen products have the following labeling notes:
Conjugated estrogen vaginal cream (Premarin^a)	Moderate to severe dyspareunia due to menopause	WHI: Estrogen alone was not associated with increased risk of breast cancer; estrogen plus progestin increased the risk
	Atrophic vaginitis and kraurosis vulvae	Contraindication: known, suspected, or history of breast cancer
17-beta estradiol vaginal ring (Estring)	Moderate to severe vulvar and vaginal atrophy due to menopause	Warning: Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration
Estradiol hemihydrate vaginal tablets (Vagifem, Yuvafem^b)	Atrophic vaginitis due to menopause
Estradiol vaginal inserts (Imvexxy)	GSM, dyspareunia
Combination estrogen product
Conjugated estrogens/bazedoxifene (Duavee)	Moderate to severe vasomotorsymptoms associated with menopause
Nonestrogen products
Prasterone vaginal tablet (Intrarosa; contains dehydroepiandrosterone)	Moderate to severe dyspareunia due to menopause	Warning: Estrogen is a metabolite of prasterone; use of exogenous extrogen is contraindicated in women with known or suspected breast cancer; prasterone has not been studied in women with a history of breast cancer
Ospemifene (Osphena) oral tablet	Moderate to severe dyspareunia due to menopause	Warning: Ospemifene has not been adequately studied in women with breast cancer; there-fore, it should not be used in women with known or suspected breast cancer or with a history of breast cancer

↵a Premarin vaginal cream is the only locally applied preparation with FDA approval for dyspareunia due to GSM.
↵b Yuvafem is an FDA-approved generic equivalent to Vagifem.
FDA = US Food and Drug Administration; GSM = genitourinary syndrome of menopause; WHI = Women’s Health Initiative study