# US 12,005,138 B2 · Treatment of endometriosis by intravaginal administration of a low dose of a selective progesterone receptor modulator (SPRM), anti-progestin, or anti-progestational agent

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- Number: US 12,005,138 B2
- Document ID: US12005138B2
- Status: Granted
- Kind: B2
- Application number: 17/401,964
- Filed: 2021-08-13
- Published: 2021-12-02
- Granted: 2024-06-11
- Earliest claimed: 2011-03-10
- Assignees: Arkady Rubin
- Applicants: Arkady Rubin
- Inventors: Arkady Rubin
- Web page: https://patentgrep.com/patent/US12005138B2

## CPC

- A61K 9/0036: {Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms}
- A61K 9/0039: {Devices retained in the uterus for a prolonged period, e.g. intrauterine devices for contraception}
- A61K 31/569: substituted in position 17 alpha, e.g. ethisterone
- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K 31/575: substituted in position 17 beta by a chain of three or more carbon atoms, e.g. cholane, cholestane, ergosterol, sitosterol
- A61P 15/02: for disorders of the vagina
- 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

An intravaginal drug delivery device comprising: a drug delivery device, and a therapeutically effective amount of a single active agent that is therapeutically effective for the treatment of endometriosis, wherein the drug delivery device delivers the single active agent directly to endometrial implants in women diagnosed with endometriosis, wherein the single active agent is selected from the group consisting of mifepristone and metabolites thereof.

## Claims

### Claim 1

An intravaginal drug delivery device comprising:
a drug delivery device; and
a therapeutically effective amount of a single active agent that is therapeutically effective for the treatment of endometriosis, wherein the drug delivery device delivers the single active agent directly to endometrial implants in women diagnosed with endometriosis, wherein the drug delivery device delivers a daily dose of the single active agent which ranges from 10 mcg to 50 mcg, wherein the single active agent is selected from the group consisting of mifepristone and metabolites thereof.

### Claim 2 (depends on 1)

The drug delivery device of claim 1, wherein the drug delivery device is any one of: a vaginal ring, a medicated intrauterine device (IUD), and a vaginal tablet.

### Claim 3 (depends on 2)

The drug delivery device of claim 2, wherein the single active agent is contained in the vaginal ring in any one of the following forms: mixed throughout the vaginal ring, distributed uniformly throughout the vaginal ring; encapsulated in a part of the vaginal ring, located at the center of the vaginal ring, and placed between an un-medicated core and a metering layer of the vaginal ring.

### Claim 4 (depends on 2)

The drug delivery device of claim 2, wherein the single active agent is mifepristone with the daily dose ranging from 25 mcg to 50 mcg.

### Claim 5 (depends on 2)

The drug delivery device of claim 2, which is a vaginal ring that daily delivers an amount of the mifepristone ranging from 10 mcg to 25 mcg.

### Claim 6 (depends on 2)

The drug delivery device of claim 2, which is a medicated intrauterine device (IUD) that daily delivers an amount of the mifepristone ranging from 10 mcg to 50 mcg.