# US 2019/0375783 A1 · Selective progesterone receptor modulator (sprm) regimen

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- Number: US 2019/0375783 A1
- Document ID: US20190375783A1
- Status: Published application
- Kind: A1
- Application number: 16/538,165
- Filed: 2019-08-12
- Published: 2019-12-12
- Earliest claimed: 2015-05-18
- Assignees: Bayer Pharma Aktiengesellschaft
- Applicants: Bayer Pharma Aktiengesellschaft
- Inventors: Christian SEITZ; Rudolf KNAUTHE; Susan ZEUN
- Web page: https://patentgrep.com/patent/US20190375783A1

## CPC

- C07J 31/006: {not covered by C07J31/003}
- A61K 31/567: substituted in position 17 alpha, e.g. mestranol, norethandrolone
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- C07J: STEROIDS (seco-steroids C07C)
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

The invention is directed to a pharmaceutical composition comprising a progesterone receptor antagonist namely (11β, 17β)-17-Hydroxy-11-[4-(methylsulphonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one for the treatment and/or prophylaxis of Uterine Fibroids (myomas, uterine leiomyoma) that is administered to a patient diagnosed with Uterine Fibroids following a specific regimen. Additionally, the invention is directed to a method for treating Uterine Fibroids (myomas, uterine leiomyoma) and/or for reducing Uterine Fibroids (myomas, uterine leiomyoma) size and symptoms related to Uterine Fibroids following a specific regimen as well as treatment of Heavy Menstrual Bleeding (HMB).

## Claims

### Claim 1

A method for treating Heavy Menstrual Bleeding (HMB) by administering to a patient a pharmaceutical composition comprising (11β,17β)-17-Hydroxy-11-[4-(methylsulphonyl)phenyl]-17-(pentafluoroethyl)estra-4,9-dien-3-one (Compound 1) of formula
or salts, solvates or solvates of the salts, including all crystal modifications thereof, comprising the steps of:
administering the pharmaceutical composition daily during a period of four (4) weeks to one (1) year, and
discontinuing the administration until one (1) or two (2) bleeding episodes occur.

### Claim 2 (depends on 1)

The method of claim 1 wherein the administering step and the discontinuing step are repeated at least one (1) time.

### Claim 3 (depends on 1)

The method of claim 1 wherein the period is from twelve (12) weeks up to twenty-four (24) weeks.

### Claim 4 (depends on 1)

The method of claim 1 wherein the period is selected from the group consisting of twelve (12) weeks; sixteen (16) weeks; twenty (20) weeks; and twenty-four (24) weeks.

### Claim 5 (depends on 4)

The method of claim 4, wherein the period is twelve (12) weeks.

### Claim 6 (depends on 5)

The method of claim 5, wherein the administration is discontinued until one (1) bleeding period occurs.

### Claim 7 (depends on 6)

The method of claim 6, wherein the bleeding period is followed by administration for twelve (12) weeks.

### Claim 8 (depends on 4)

The method of claim 4, wherein the period is twenty-four (24) weeks.

### Claim 9 (depends on 8)

The method of claim 8, wherein the administration is discontinued until two (2) bleeding periods occur.

### Claim 10 (depends on 9)

The method of claim 9, wherein the second bleeding period is followed by administration for twenty-four (24) weeks.

### Claim 11 (depends on 1)

The method of claim 1, wherein amenorrhea occurs after about three (3) weeks.

### Claim 12 (depends on 5)

The method of claim 5, wherein amenorrhea occurs after about three (3) weeks.

### Claim 13 (depends on 8)

The method of claim 8, wherein amenorrhea occurs after about three (3) weeks.

### Claim 14 (depends on 1)

The method of claim 1, wherein Compound 1 is administered at a dose of 1 mg to 5 mg.

### Claim 15 (depends on 5)

The method of claim 5, wherein Compound 1 is administered at a dose of 1 mg to 5 mg.

### Claim 16 (depends on 8)

The method of claim 8, wherein Compound 1 is administered at a dose of 1 mg to 5 mg.

### Claim 17 (depends on 1)

The method of claim 1, wherein Compound 1 is administered at a dose of about 2 mg.

### Claim 18 (depends on 5)

The method of claim 5, wherein Compound 1 is administered at a dose of about 2 mg.

### Claim 19 (depends on 8)

The method of claim 8, wherein Compound 1 is administered at a dose of about 2 mg.

### Claim 20 (depends on 4)

The method of claim 4, wherein the period is sixteen (16) weeks.