US 11,918,583 B2
Treatment of heavy menstrual bleeding associated with uterine fibroids
Brendan Mark Johnson, Chapel Hill, NC (US); Lynn Seely, San Mateo, CA (US); Paul N. Mudd, Jr., Cary, NC (US); Susan Wollowitz, Lafayette, CA (US); Mark Hibberd, Hampshire (GB); Masataka Tanimoto, Osaka (JP); Vijaykumar Reddy Rajasekhar, Apple Valley, CA (US); and Mayukh Vasant Sukhatme, Mamaroneck, NY (US)
Assigned to Sumitomo Pharma Switzerland GmbH, Basel (CH); and Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed by Sumitomo Pharma Switzerland GmbH, Basel (CH); and Takeda Pharmaceutical Company Limited, Osaka (JP)
Filed on Jul. 15, 2022, as Appl. No. 17/866,201.
Application 17/866,201 is a division of application No. 17/317,769, filed on May 11, 2021, granted, now 11,793,812, issued on Oct. 24, 2023.
Application 17/317,769 is a division of application No. 16/370,299, filed on Mar. 29, 2019, granted, now 11,033,551, issued on Jun. 15, 2021.
Application 16/370,299 is a continuation of application No. PCT/EP2017/074907, filed on Sep. 29, 2017.
Claims priority of provisional application 62/528,409, filed on Jul. 3, 2017.
Claims priority of provisional application 62/492,839, filed on May 1, 2017.
Claims priority of provisional application 62/402,034, filed on Sep. 30, 2016.
Claims priority of provisional application 62/402,055, filed on Sep. 30, 2016.
Claims priority of provisional application 62/402,150, filed on Sep. 30, 2016.
Prior Publication US 2022/0370462 A1, Nov. 24, 2022
This patent is subject to a terminal disclaimer.
Int. Cl. A61K 31/519 (2006.01); A61K 31/513 (2006.01); A61K 31/565 (2006.01); A61K 31/57 (2006.01); A61P 15/00 (2006.01); A61K 9/00 (2006.01)
CPC A61K 31/519 (2013.01) [A61K 31/513 (2013.01); A61P 15/00 (2018.01); A61K 9/0053 (2013.01); A61K 31/565 (2013.01); A61K 31/57 (2013.01)] 22 Claims
 
1. A method of treating heavy menstrual bleeding associated with uterine fibroids in a pre-menopausal woman in need thereof, the method comprising:
orally administering a single dosage form comprising about 40 mg of relugolix or a corresponding amount of a pharmaceutically acceptable salt thereof, about 1.0 mg estradiol, and about 0.5 mg norethindrone acetate to the woman once daily;
wherein during treatment the pre-menopausal woman has:
a menstrual blood loss volume of less than 80 mL per menstrual cycle; or
a 50% reduction from baseline-in menstrual blood loss volume, compared to the woman's baseline before beginning treatment; or
a combination thereof.