TABLE 2

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

ProductsGSM indicationsBreast cancer effects
Estrogen products
17-beta estradiol vaginal cream (Estrace)Moderate to severe vulvar and vaginal atrophy due to menopauseAll estrogen products have the following labeling notes:
WHI: Estrogen alone was not associated with increased risk of breast cancer; estrogen plus progestin increased the risk
Contraindication: known, suspected, or history of breast cancer
Warning: Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration
Conjugated estrogen vaginal cream (Premarina)Moderate to severe dyspareunia due to menopause
Atrophic vaginitis and kraurosis vulvae
17-beta estradiol vaginal ring (Estring)Moderate to severe vulvar and vaginal atrophy due to menopause
Estradiol hemihydrate vaginal tablets (Vagifem, Yuvafemb)Atrophic vaginitis due to menopause
Estradiol vaginal inserts (Imvexxy)GSM, dyspareunia
Combination estrogen product
Conjugated estrogens/bazedoxifene (Duavee)Moderate to severe vasomotor symptoms associated with menopause
Nonestrogen products
Prasterone vaginal tablet (Intrarosa; contains dehydroepiandrosterone)Moderate to severe dyspareunia due to menopauseWarning: Prasterone 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 tabletModerate to severe dyspareunia due to menopauseWarning: Ospemifene has not been adequately studied in women with breast cancer; therefore, 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