Granted Patent
B2
US 12,458,651 · App. 17/972,403 · Granted Nov 4, 2025
Compounds and their uses for alleviating menopause-associated symptoms
Inventors:
Melanie Taziaux (Liege, BE); Glwadys Rausin (Trooz, BE); Maud Jost (Liege, BE); Marie Mawet (Angleur, BE)
Assignee:
ESTETRA SRL
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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 specified daily doses, 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 (20)
1 . A method of alleviating psychological menopause-associated symptoms in a subject in need thereof, wherein the psychological menopause-associated symptoms comprise one or more selected from depression, irritability, anxiety, and nervous tension, wherein said method comprises administering to the subject an estetrol component at a daily amount equivalent to from about 15 mg to about 25 mg of estetrol.
2 . The method according to claim 1 , wherein the psychological menopause-associated symptoms are selected from anxiety and nervous tension.
3 . The method according to claim 1 , wherein the estetrol component is administered at a daily amount equivalent to from about 15 mg to about 20 mg of estetrol.
4 . The method according to claim 1 , wherein the estetrol component is administered at a daily amount equivalent to about 20 mg.
5 . The method according to claim 1 , wherein the estetrol component is administered daily for at least 4 weeks.
6 . The method according to claim 1 , further comprising administering a progestogenic component to the subject.
7 . The method according to claim 6 , wherein the progestogenic component is selected from drospirenone, progesterone and dydrogesterone.
8 . The method according to claim 6 , wherein the progestogenic component is progesterone and is administered at a daily dose of from 50 mg to 200 mg.
9 . The method according to claim 6 , wherein the progestogenic component is administered in the same composition as the estetrol component.
10 . The method according to claim 1 , further comprising administering bazedoxifene to the subject.
11 . The method according to claim 10 , wherein the bazedoxifene is administered in the same composition as the estetrol component.
12 . The method according to claim 1 , wherein the estetrol component is estetrol monohydrate.
13 . The method according to claim 1 , wherein the estetrol component is administered in a composition formulated as an oral dosage unit.
14 . The method according to claim 13 , wherein the oral dosage unit is a daily solid oral dosage unit formulated to provide a daily dosage of the estetrol component.
15 . The method according to claim 14 , wherein the daily solid oral dosage unit is provided in containers of a packaging unit comprising at least 14 of the containers that are configured to contain separately packaged and individually removable daily solid oral dosage units.
16 . The method according to claim 15 , wherein at least a portion of the separately packaged and individually removable daily solid oral dosage units further comprise a progestogenic component, or wherein the packaging unit further comprises at least 10 additional containers containing additional separately packaged and individually removable daily solid oral dosage units that comprise a progestogenic component.
17 . The method according to claim 16 , wherein the progestogenic component is selected from drospirenone, progesterone and dydrogesterone.
18 . The method according to claim 16 , wherein the progestogenic component is progesterone and wherein each daily solid oral dosage unit comprising the progestogenic component comprises from about 50 mg to about 200 mg of progesterone.
19 . The method according to claim 16 , wherein at least 10 of the daily solid oral dosage units comprise a progestogenic component.
20 . The method according to claim 19 , wherein each of the daily solid oral dosage units comprises a progestogenic component.
Assignments (2)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Oct 24, 2022
From: TAZIAUX, MELANIE; RAUSIN, GLWADYS; JOST, MAUD; MAWET, MARIE
To: ESTETRA SPRL
Reel/Frame 061519/0983 →
Priority Claims (3)
EP 18168336
· Apr 19, 2018
· regional
EP 18174982
· May 30, 2018
· regional
EP 19150423
· Jan 4, 2019
· regional
Continuity (4)
Continuation
17048538
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