Gonadotropin-releasing hormone antagonist dosing regimens for the treatment of endometriosis
The invention provides methods of treating endometriosis in a patient by administration of a gonadotropin-releasing hormone (GnRH) antagonist, for instance, according to dosing regimens predicated on the patient's level of anti-Müllerian hormone (AMH) or β17-estradiol (E2).
1. A method of reducing endometriosis-associated pain in a female human patient having endometriosis, the method comprising administering to the patient a compound represented by formula (II)
or a pharmaceutically acceptable salt thereof, in an amount of about 200 mg per day.
2. A method of treating endometriosis in a female human patient in need thereof, the method comprising administering to the patient a compound represented by formula (II)
or a pharmaceutically acceptable salt thereof, in an amount of about 200 mg per day.
3. A method of reducing the concentration of β17-estradiol, follicle-stimulating hormone, and/or luteinizing hormone in a female human patient having endometriosis, the method comprising administering to the patient a compound represented by formula (II)
or a pharmaceutically acceptable salt thereof, in an amount of about 200 mg per day.
4. The method of claim 1 , wherein the compound represented by formula (II) is administered to the patient in the form of the choline salt of formula (II).
5. The method of claim 1 , wherein the compound is administered to the patient orally.
6. The method of claim 1 , wherein the compound is administered to the patient once daily.
7. The method of claim 1 , wherein the patient is further administered add-back therapy.
8. The method of claim 7 , wherein the add-back therapy is administered to the patient once daily.
9. The method of claim 7 , wherein the add-back therapy comprises an estrogen.
10. The method of claim 9 , wherein the estrogen is β17-estradiol.
11. The method of claim 10 , wherein the β17-estradiol is administered to the patient in an amount of about 1.0 mg per day.
12. The method of claim 7 , wherein the add-back therapy comprises a progestin.
13. The method of claim 12 , wherein the progestin is norethindrone acetate.
14. The method of claim 13 , wherein the norethindrone acetate is administered to the patient in an amount of about 0.5 mg per day.
15. The method of claim 7 , wherein the add-back therapy comprises about 1.0 mg of β17-estradiol and about 0.5 mg of norethindrone acetate.
16. The method of claim 15 , wherein the add-back therapy is administered to the patient once daily.
17. A kit comprising a compound represented by formula (II)
or a pharmaceutically acceptable salt thereof, in a unit dosage form of about 200 mg, and a package insert instructing a user of the kit to perform the method of claim 1 .
18. A kit comprising a compound represented by formula (II)
or a pharmaceutically acceptable salt thereof, in a unit dosage form of about 200 mg, and a package insert instructing a user of the kit to perform the method of claim 2 .
19. A kit comprising a compound represented by formula (II)
or a pharmaceutically acceptable salt thereof, in a unit dosage form of about 200 mg, and a package insert instructing a user of the kit to perform the method of claim 3 .
20. The kit of claim 17 , wherein the compound is present in the kit in the form of the choline salt of formula (II).