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 (Premarina) | 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, Yuvafemb) | 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 |