METHOD FOR THE MANAGEMENT OF DYSMENORRHEA AND MENSTRUAL PAIN
The present invention relates to a method for the management of dysmenorrhea involving administration of an estrogenic component which is preferably selected from the group consisting of estetrol and estetrol-like compounds. Estetrol-like compounds have been surprisingly found to be capable of mitigating dysmenorrhea, either when used alone or in combination with progestogenic components, and this to an extent surpassing the effect obtained with other compositions and with a favourable side-effect profile compared to currently available methods.
1 - 17 . (canceled)
18 . A method of alleviating the symptoms of dysmenorrhea in a person in need thereof, comprising orally administering to the person an effective amount of an estetrol component.
19 . The method of claim 18 , further comprising orally administering to the person a progestogenic component.
20 . The method of claim 19 , wherein the estetrol component and the progestogenic component are administered in the same composition.
21 . The method of claim 20 , wherein the composition is an oral dosage unit providing a daily dose of the estetrol component and the progestogenic component.
22 . The method of claim 19 , wherein the progestogenic component is selected from progesterone, desogestrel, gestodene, dienogest, levonorgestrel, norgestimate, norethisterone, drospirenone, trimegestone, dydrogesterone, precursors of these progestogens, and mixtures of any thereof.
23 . The method of claim 19 , wherein the progestogenic component is drospirenone.
24 . The method of claim 18 , wherein the estetrol component is administered at a daily dose of from 1 mg to 40 mg.
25 . The method of claim 18 , wherein the estetrol component is administered at a daily dose of from 5 mg to 25 mg.
26 . The method of claim 19 , wherein the drospirenone is administered at a daily dose of from 0.5 mg to 10 mg.
27 . The method of claim 19 , wherein the drospirenone is administered at a daily dose of from 1 mg to 4 mg.
28 . The method of claim 18 , wherein the estetrol component is estetrol monohydrate.
29 . The method of claim 18 , wherein the estetrol is administered at a daily dose of about 15 mg.
30 . The method of claim 29 , further comprising administering drospirenone at a daily dose of about 3 mg.
31 . The method of claim 18 , wherein the method is effective to improve dysmenorrhea symptoms after 10 days of daily administration.
32 . The method of claim 31 , wherein the method is effective to improve the person's dysmenorrhea symptoms grade by at least one unit.
33 . The method of claim 18 , wherein the persons' haemostatic changes do not exceed the boundaries of a normal range after daily administration for one menstrual cycle of at least 28 days.
34 . The method of claim 18 , wherein the method comprises an administration-free interval of about 7 days.
35 . The method of claim 18 , wherein the method comprises an administration-free interval of about 4 days.
36 . The method of claim 19 , comprising a 24-day interval during which the estetrol component and progestogenic component are administered, alternating with a 4-day interval during which only the estetrol component is administered.