IP Library › Granted Patent US 12,390,478
Granted Patent B2
US 12,390,478 · App. 17/893,999 · Granted Aug 19, 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
A61K31/585A61K9/0053A61K31/55A61K31/565A61K31/57A61K31/573A61P15/12
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Quick Facts
Patent No.
US 12,390,478
App. No.
17/893,999
Granted
Aug 19, 2025
Kind
B2
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 (29)

1. A method of hormone replacement therapy, comprising administering daily to a post-menopausal female subject a pharmaceutical composition comprising 15-25 mg of estetrol, wherein the treated subject is no more likely to experience an adverse event than an individual who is treated with daily administration of 10 mg of estetrol.

2. The method of claim 1 , wherein the administration of estetrol to the subject does not modify one or more haemostatic parameters of the subject.

3. The method of claim 1 , wherein the pharmaceutical composition comprises 15 mg of estetrol.

4. The method of claim 3 , wherein the estetrol is estetrol monohydrate.

5. The method of claim 1 , wherein the pharmaceutical composition comprises 20 mg of estetrol.

6. The method of claim 5 , wherein the estetrol is estetrol monohydrate.

7. The method of claim 1 , wherein the pharmaceutical composition is a solid oral dosage form.

8. A method of hormone replacement therapy, comprising administering daily to a post-menopausal female subject a pharmaceutical composition comprising 15-25 mg of estetrol, wherein the administration of estetrol does not increase the subject's risk of a severe adverse event relative to placebo.

9. The method of claim 8 , wherein the administration of estetrol to the subject does not modify one or more haemostatic parameters of the subject.

10. The method of claim 8 , wherein the pharmaceutical composition comprises 15 mg of estetrol.

11. The method of claim 10 , wherein the estetrol is estetrol monohydrate.

12. The method of claim 8 , wherein the pharmaceutical composition comprises 20 mg of estetrol.

13. The method of claim 12 , wherein the estetrol is estetrol monohydrate.

14. The method of claim 8 , wherein the pharmaceutical composition is a solid oral dosage form.

15. A method of hormone replacement therapy, comprising administering daily to a post-menopausal female subject a pharmaceutical composition comprising 15-25 mg of estetrol, wherein the administration of 15-25 mg of estetrol does not increase the subject's risk of a severe adverse event relative to daily administration of 10 mg of estetrol.

16. The method of claim 15 , wherein the administration of estetrol to the subject does not modify one or more haemostatic parameters of the subject.

17. The method of claim 15 , wherein the pharmaceutical composition comprises 15 mg of estetrol.

18. The method of claim 17 , wherein the estetrol is estetrol monohydrate.

19. The method of claim 15 , wherein the pharmaceutical composition comprises 20 mg of estetrol.

20. The method of claim 19 , wherein the estetrol is estetrol monohydrate.

21. The method of claim 15 , wherein the pharmaceutical composition is a solid oral dosage form.

22. A method of providing hormone replacement therapy without increasing a subject's risk of treatment-emergent adverse events (TEAEs), comprising administering daily to a post-menopausal female subject a pharmaceutical composition comprising 15-25 mg of estetrol, wherein the treated subject's risk of developing a TEAE is not significantly higher than that of an individual being treated with a daily administration of 10 mg of estetrol.

23. The method of claim 22 , wherein the administration of estetrol to the subject does not modify one or more haemostatic parameters of the subject.

24. The method of claim 22 , wherein the pharmaceutical composition comprises 15 mg of estetrol.

25. The method of claim 24 , wherein the estetrol is estetrol monohydrate.

26. The method of claim 22 , wherein the pharmaceutical composition comprises 20 mg of estetrol.

27. The method of claim 26 , wherein the estetrol is estetrol monohydrate.

28. The method of claim 22 , wherein the pharmaceutical composition is a solid oral dosage form.

29. A method of hormone replacement therapy, comprising administering daily to a post-menopausal female subject a pharmaceutical composition comprising 15-25 mg of estetrol, wherein the treated subject is no more likely to experience an adverse event than an individual who is not undergoing hormone replacement therapy.

Assignments (2)
CHANGE OF NAME Recorded Oct 27, 2022
From: ESTETRA SPRL
To: ESTETRA SRL
Reel/Frame 061786/0582 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Sep 26, 2022
From: TAZIAUX, MELANIE; RAUSIN, GLWADYS; JOST, MAUD; MAWET, MARIE
To: ESTETRA SPRL
Reel/Frame 061219/0491 →
Priority Claims (3)
EP 18168336 · Apr 19, 2018 · regional
EP 18174982 · May 30, 2018 · regional
EP 19150423 · Jan 4, 2019 · regional
Continuity (2)
Continuation 17048538
Related Publication 20230031329A1 · Feb 2, 2023
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