# US 2019/0167700 A1 · Method for the management of dysmenorrhea and menstrual pain

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- Number: US 2019/0167700 A1
- Document ID: US20190167700A1
- Status: Published application
- Kind: A1
- Application number: 16/323,110
- Filed: 2017-08-07
- Published: 2019-06-06
- Earliest claimed: 2016-08-05
- Assignees: Estetra Sprl
- Applicants: Estetra Sprl
- Inventors: Maud JOST; Glwadys RAUSIN
- Web page: https://patentgrep.com/patent/US20190167700A1

## CPC

- A61K 31/585: containing lactone rings, e.g. oxandrolone, bufalin
- A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K 31/566: having an oxo group in position 17, e.g. estrone
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- 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 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.

## Claims

### Claim at position 1

1-17. (canceled)

### Claim 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.

### Claim 19 (depends on 18)

The method of claim 18, further comprising orally administering to the person a progestogenic component.

### Claim 20 (depends on 19)

The method of claim 19, wherein the estetrol component and the progestogenic component are administered in the same composition.

### Claim 21 (depends on 20)

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.

### Claim 22 (depends on 19)

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.

### Claim 23 (depends on 19)

The method of claim 19, wherein the progestogenic component is drospirenone.

### Claim 24 (depends on 18)

The method of claim 18, wherein the estetrol component is administered at a daily dose of from 1 mg to 40 mg.

### Claim 25 (depends on 18)

The method of claim 18, wherein the estetrol component is administered at a daily dose of from 5 mg to 25 mg.

### Claim 26 (depends on 19)

The method of claim 19, wherein the drospirenone is administered at a daily dose of from 0.5 mg to 10 mg.

### Claim 27 (depends on 19)

The method of claim 19, wherein the drospirenone is administered at a daily dose of from 1 mg to 4 mg.

### Claim 28 (depends on 18)

The method of claim 18, wherein the estetrol component is estetrol monohydrate.

### Claim 29 (depends on 18)

The method of claim 18, wherein the estetrol is administered at a daily dose of about 15 mg.

### Claim 30 (depends on 29)

The method of claim 29, further comprising administering drospirenone at a daily dose of about 3 mg.

### Claim 31 (depends on 18)

The method of claim 18, wherein the method is effective to improve dysmenorrhea symptoms after 10 days of daily administration.

### Claim 32 (depends on 31)

The method of claim 31, wherein the method is effective to improve the person's dysmenorrhea symptoms grade by at least one unit.

### Claim 33 (depends on 18)

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.

### Claim 34 (depends on 18)

The method of claim 18, wherein the method comprises an administration-free interval of about 7 days.

### Claim 35 (depends on 18)

The method of claim 18, wherein the method comprises an administration-free interval of about 4 days.

### Claim 36 (depends on 19)

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.