Claims for Patent: 11,793,812
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Summary for Patent: 11,793,812
| Title: | Methods of treating endometriosis |
| Abstract: | Methods for treating uterine fibroids, endometriosis, adenomyosis, or heavy menstrual bleeding in a subject, which include administering to the subject from 10 mg to 60 mg per day of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, and from 0.01 mg to 5 mg per day of a hormone replacement medicament. The present disclosure has methods for reducing menstrual bleeding in a subject, reducing bone mineral density loss in a subject caused by administering a GnRH antagonist to the subject, suppressing sex hormones in a subject, reducing vasomotor symptoms or hot flashes in a subject, and reducing symptoms of decreased libido in a subject having uterine fibroids, endometriosis, or adenomyosis. Further provided are methods of maintaining blood glucose profile, maintaining lipid profile, and/or maintaining bone mineral density in a pre-menopausal woman being treated for one or more conditions or symptoms of endometriosis, adenomyosis, uterine fibroids, or heavy menstrual bleeding; and methods of contraception and treating infertility. |
| Inventor(s): | Brendan Mark JOHNSON, Lynn Seely, Paul N. MUDD, Jr., Susan Wollowitz, Mark Hibberd, Masataka TANIMOTO, Vijaykumar Reddy RAJASEKHAR, Mayukh Vasant SUKHATME |
| Assignee: | Sumitomo Pharma Switzerland GmbH, Takeda Pharmaceutical Co Ltd, Roivant Sciences Inc |
| Application Number: | US17/317,769 |
| Patent Claims: |
1. A method for treating pain associated with endometriosis in a pre-menopausal woman in need thereof, the method comprising orally administering to the pre-menopausal woman, once-daily, a combination comprising about 40 mg of N-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-N′-methoxyurea, or a corresponding amount of a pharmaceutically acceptable salt thereof; about 1.0 mg of estradiol; and about 0.5 mg of norethindrone acetate; wherein the pre-menopausal woman's ovarian estrogen production is suppressed, as demonstrated by prevention of ovulation; wherein the pre-menopausal woman's bone mineral density during treatment is within ±3% of the pre-menopausal woman's bone mineral density prior to treatment; and wherein the method reduces said pain. 2. The method of claim 1, wherein the pre-menopausal woman's bone mineral density during treatment is within ±2% of the pre-menopausal woman's bone mineral density prior to treatment. 3. The method of claim 1, wherein the pre-menopausal woman's daily serum estradiol concentration is between 20 pg/ml and 50 pg/ml between daily doses of the combination. 4. The method of claim 1, wherein the pre-menopausal woman is a peri-menopausal woman. |
