Compounds and their uses for alleviating menopause-associated symptoms
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.
1. A method of treating moderate to severe vasomotor symptoms (VMS) associated with menopause, comprising orally administering once daily a composition formulated as a daily oral dosage unit comprising 20 mg estetrol monohydrate.
2. The method of claim 1 , further comprising orally administering a progestogenic component.
3. The method of claim 2 , wherein said progestogenic component is selected from drospirenone, progesterone, and dydrogesterone.
4. The method of claim 2 , wherein said progestogenic component is progesterone and is administered at a daily dose of from 50 mg to 200 mg.
5. The method of claim 2 , wherein said progestogenic component is administered in the same composition as the estetrol monohydrate.
6. The method of claim 1 , further comprising administering bazedoxifene.
7. The method of claim 6 , wherein said bazedoxifene is administered in the same composition as the estetrol monohydrate.
8. A method of treating moderate to severe vasomotor symptoms (VMS) associated with menopause, comprising orally administering once daily to a woman with a uterus a composition formulated as a daily oral dosage unit comprising 20 mg estetrol monohydrate.
9. The method of claim 8 , further comprising orally administering a progestogenic component.
10. The method of claim 9 , wherein said progestogenic component is selected from drospirenone, progesterone, and dydrogesterone.
11. The method of claim 9 , wherein said progestogenic component is progesterone and is administered at a daily dose of from 50 mg to 200 mg.
12. The method of claim 9 , wherein said progestogenic component is administered in the same composition as the estetrol monohydrate.
13. The method of claim 8 , further comprising administering bazedoxifene.
14. The method of claim 13 , wherein said bazedoxifene is administered in the same composition as the estetrol monohydrate.
15. A method of treating moderate to severe vasomotor symptoms (VMS) associated with menopause, comprising orally administering once daily to a woman without a uterus a composition formulated as a daily oral dosage unit comprising 20 mg estetrol monohydrate.
16. The method of claim 15 , further comprising orally administering a progestogenic component.
17. The method of claim 16 , wherein said progestogenic component is selected from drospirenone, progesterone, and dydrogesterone.
18. The method of claim 16 , wherein said progestogenic component is progesterone and is administered at a daily dose of from 50 mg to 200 mg.
19. The method of claim 16 , wherein said progestogenic component is administered in the same composition as the estetrol monohydrate.
20. The method of claim 15 , further comprising administering bazedoxifene.
21. The method of claim 15 , wherein said bazedoxifene is administered in the same composition as the estetrol monohydrate.