US2023025785A1PendingUtilityA1

Compounds and their uses for alleviating menopause-associated symptoms

66
Assignee: ESTETRA SRLPriority: Apr 19, 2018Filed: Aug 31, 2022Published: Jan 26, 2023
Est. expiryApr 19, 2038(~11.8 yrs left)· nominal 20-yr term from priority
Inventors:Melanie TaziauxGlwadys RausinMaud JostMarie Mawet
A61K 31/57A61K 31/585A61K 31/565A61K 31/573A61K 9/0053A61P 15/12A61K 31/55A61K 2300/00A61K 45/06A61P 5/30
66
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Claims

Abstract

The present invention relates to a hormone replacement therapy, to the associated compounds and to the associated packaging units, for alleviating menopause-associated symptoms which is based on the administration to a female mammal of an estetrol component at a specific daily dose, optionally in combination with a progestogenic component. The therapy enjoys a statistically significant efficacy combined with a favourable profile for side effects compared to currently available methods for alleviating menopause-associated symptoms.

Claims

exact text as granted — not AI-modified
1 - 15 . (canceled) 
     
     
         16 . A method of treating moderate to severe vasomotor symptoms (VMS) associated with menopause, comprising administering once daily a composition comprising about 15 mg estetrol. 
     
     
         17 . The method of  claim 16 , further comprising administering a progestogenic component. 
     
     
         18 . The method of  claim 17 , wherein said progestogenic component is selected from drospirenone, progesterone, and dydrogesterone. 
     
     
         19 . The method of  claim 17 , wherein said progestogenic component is progesterone and is administered at a daily dose of from 50 mg to 200 mg. 
     
     
         20 . The method of  claim 17 , wherein said progestogenic component is administered in the same composition as the estetrol. 
     
     
         21 . The method of  claim 16 , wherein said estetrol is estetrol monohydrate. 
     
     
         22 . The method of  claim 16 , further comprising administering bazedoxifene. 
     
     
         23 . The method of  claim 22 , wherein said bazedoxifene is administered in the same composition as the estetrol. 
     
     
         24 . A method of treating moderate to severe vasomotor symptoms (VMS) associated with menopause, comprising administering once daily to a woman with a uterus a composition comprising about 15 mg estetrol. 
     
     
         25 . The method of  claim 24 , further comprising administering a progestogenic component. 
     
     
         26 . The method of  claim 25 , wherein said progestogenic component is selected from drospirenone, progesterone, and dydrogesterone. 
     
     
         27 . The method of  claim 25 , wherein said progestogenic component is progesterone and is administered at a daily dose of from 50 mg to 200 mg. 
     
     
         28 . The method of  claim 25 , wherein said progestogenic component is administered in the same composition as the estetrol. 
     
     
         29 . The method of  claim 24 , wherein said estetrol is estetrol monohydrate. 
     
     
         30 . The method of  claim 24 , further comprising administering bazedoxifene. 
     
     
         31 . The method of  claim 30 , wherein said bazedoxifene is administered in the same composition as the estetrol. 
     
     
         32 . A method of treating moderate to severe vasomotor symptoms (VMS) associated with menopause, comprising administering once daily to a woman without a uterus a composition comprising about 15 mg estetrol. 
     
     
         33 . The method of  claim 32 , further comprising administering a progestogenic component. 
     
     
         34 . The method of  claim 33 , wherein said progestogenic component is selected from drospirenone, progesterone, and dydrogesterone. 
     
     
         35 . The method of  claim 33 , wherein said progestogenic component is progesterone and is administered at a daily dose of from 50 mg to 200 mg. 
     
     
         36 . The method of  claim 33 , wherein said progestogenic component is administered in the same composition as the estetrol. 
     
     
         37 . The method of  claim 32 , wherein said estetrol is estetrol monohydrate. 
     
     
         38 . The method of  claim 32 , further comprising administering bazedoxifene. 
     
     
         39 . The method of  claim 38 , wherein said bazedoxifene is administered in the same composition as the estetrol.

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