# US 2014/0194460 A1 · Treatment of endometriosis

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- Number: US 2014/0194460 A1
- Document ID: US20140194460A1
- Status: Published application
- Kind: A1
- Application number: 13/961,027
- Filed: 2013-08-07
- Published: 2014-07-10
- Earliest claimed: 2009-06-26
- Assignees: Ferring B.V.
- Applicants: Ferring B.V.
- Inventors: Antonio Pellicer-Martinez; Carlos Simon-Valles; Edurne Novella-Maestre; Joan Carles Arce Saez
- Web page: https://patentgrep.com/patent/US20140194460A1

## CPC

- A61K 31/473: ortho- or peri-condensed with carbocyclic ring systems, e.g. acridines, phenanthridines
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
- A61P 15/18: Feminine contraceptives
- A61P 25/04: Centrally acting analgesics, e.g. opioids
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- A61P 35/00: Antineoplastic agents
- 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

A pharmaceutical composition comprising quinagolide for the treatment and/or prevention of endometriosis.

## Claims

### Claim at position 1

1-19. (canceled)

### Claim 20

A method of treatment or prevention of endometriosis, treatment or prevention or management of non-menstrual pelvic pain or dysmenorrhea, or prevention of recurrence of endometriosis, in a patient in need thereof comprising:
a step of administration of a composition comprising quinagolide to the patient at a dose of between 15 and 39 micrograms quinagolide/day for 10 to 20 days;
a step of administration of a composition comprising quinagolide to the patient at a dose of between 40 and 64 micrograms quinagolide/day for 10 to 20 days; and
a step of administration of a composition comprising quinagolide to the patient at a dose of between 65 and 85 micrograms/day for at least 2 months.

### Claim 21 (depends on 20)

The method of claim 20, wherein the composition comprising quinagolide is administered at a dose of 25 micrograms quinagolide/day from day 1 to day 15 of treatment; followed by administration at a dose of 50 micrograms quinagolide/day from day 16 to day 30 of treatment; and followed by administration at a dose of 75 micrograms quinagolide/day from day 31 to at least day 87 of treatment.

### Claim 22 (depends on 20)

The method of claim 20, wherein the patient has, or is prone to, hyperprolactinemia.

### Claim 23 (depends on 20)

The method of claim 20, wherein the composition is administered in combination with other surgical or medicinal treatment for endometriosis or pain relief, or in combination with a contraceptive.

### Claim 24 (depends on 20)

The method of claim 20, wherein the patient is pregnant.

### Claim 25 (depends on 20)

The method of claim 20, wherein the endometriosis is associated with a decrease in the amount of endometrial glands; or associated with reduction or removal of an amount of endometrial tissue which is present outside the uterine cavity; or associated with reduction or amelioration of one or more symptoms associated with endometriosis.

### Claim 26 (depends on 20)

The method of claim 20, wherein the composition is administered through vagina.

### Claim 27 (depends on 20)

The method of claim 20, wherein the total treatment period is 16 to 22 weeks.

### Claim 28 (depends on 27)

The method of claim 27, wherein the total treatment period is 18 to 20 weeks.

### Claim 29 (depends on 20)

The method of claim 20, wherein the method further comprises administering a dose of 15 to 64 micrograms quinagolide/day for at least 1 day after administration of the dose of 65 to 85 micrograms/day.

### Claim 30 (depends on 20)

The method of claim 20, wherein a specified dose is reduced by 15 to 30 micrograms/day for a period of 1 to 10 days during the period of treatment.

### Claim 31

A method of treatment or prevention of endometriosis, treatment or prevention or management of non-menstrual pelvic pain or dysmenorrhea, or prevention of recurrence of endometriosis, in a patient in need thereof comprising:
a step of administration of a composition comprising quinagolide to the patient at a dose of n micrograms quinagolide/day for 10 to 20 days;
a step of administration of a composition comprising quinagolide to the patient at a dose of 2n micrograms quinagolide/day for 10 to 20 days; and
a step of administration of a composition comprising quinagolide to the patient at a dose of 3n micrograms/day for at least 2 months;
wherein n is an integer from 15 to 39.

### Claim 32 (depends on 31)

The method of claim 31, wherein the composition comprising quinagolide is administered at a dose of 25 micrograms quinagolide/day from day 1 to day 15 of treatment; followed by administration at a dose of 50 micrograms quinagolide/day from day 16 to day 30 of treatment; and followed by administration at a dose of 75 micrograms quinagolide/day from day 31 to at least day 87 of treatment.

### Claim 33 (depends on 31)

The method of claim 31, wherein the patient has, or is prone to, hyperprolactinemia.

### Claim 34 (depends on 31)

The method of claim 31, wherein the composition is administered in combination with other surgical or medicinal treatment for endometriosis or pain relief, or in combination with a contraceptive.

### Claim 35 (depends on 31)

The method of claim 31, wherein the patient is pregnant.

### Claim 36 (depends on 31)

The method of claim 31, wherein the endometriosis is associated with a decrease in the amount of endometrial glands; or associated with reduction or removal of an amount of endometrial tissue which is present outside the uterine cavity; or associated with reduction or amelioration of one or more symptoms associated with endometriosis.

### Claim 37 (depends on 31)

The method of claim 31, wherein the composition is administered through vagina.

### Claim 38 (depends on 31)

The method of claim 31, wherein the total treatment period is 16 to 22 weeks.

### Claim 39 (depends on 38)

The method of claim 38, wherein the total treatment period is 18 to 20 weeks.

### Claim 40 (depends on 31)

The method of claim 31, wherein the method further comprises administering a dose of 15 to 64 micrograms quinagolide/day for at least 1 day after administration of the dose of 3n micrograms/day.

### Claim 41 (depends on 31)

The method of claim 31, wherein a specified dose is reduced by 15 to 30 micrograms/day for a period of 1 to 10 days during the period of treatment.

### Claim 42

A method of treatment or relief of pain, treatment of infertility in a patient having endometriosis, or treatment of reproductive cancer, in a patient in need thereof, comprising a step of administration of a composition comprising quinagolide to the patient.

### Claim 43 (depends on 42)

The method of claim 42, wherein the method is for the treatment or relief of pain.

### Claim 44 (depends on 43)

The method of claim 43, wherein the treatment or relief of pain is associated with endometriosis.

### Claim 45 (depends on 42)

The method of claim 42, wherein the method is for the treatment or prevention of reproductive cancer.

### Claim 46 (depends on 45)

The method of claim 45, wherein the method is the reproductive cancer is associated with endometriosis.

### Claim 47 (depends on 42)

The method of claim 42, wherein the method is for the treatment of infertility in a patient having endometriosis.

### Claim 48 (depends on 42)

The method of claim 42, wherein the composition comprises 15 to 300 micrograms quinagolide.
