Combination hormone replacement therapy (HRT) and melatonin to prevent and treat mammary cancer

• US 20110028439A1
• Filed: 07/20/2010
• Published: 02/03/2011
• Est. Priority Date: 07/31/2009
• Status: Active Grant

• Current Assignee: Duquesne University of the Holy Spirit
• Original Assignee: Duquesne University of the Holy Spirit
• Inventors: Davis, Vicki L., Witt-Enderby, Paula A.
• Granted Patent: US 8,618,083 B2
• Time in Patent Office: Days
• US Class Current: 514/170
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/4045 Indole-alkylamines; Amides thereof, e.g. serotonin, melatonin
• CPC Class Codes: A61K 31/56 Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
• CPC Class Codes: A61K 31/566 having an oxo group in position 17, e.g. estrone
• CPC Class Codes: A61K 31/567 substituted in position 17 alpha, e.g. mestranol, norethandrolone
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 45/06 Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
• CPC Class Codes: A61P 35/00 Antineoplastic agents

Abstract

A combination hormone and melatonin therapy is provided to reduce the risk of developing, or to reduce the severity of, breast cancer by administering at least one estrogen hormone and optionally at least one progesterone-receptor-binding compound or composition and melatonin together, preferably at normal bed time.

Claims

1. A method of preventing or treating mammary cancer in a patient in need of said prevention or treatment, comprising administering in unit dosage form an estrogen, a progesterone-receptor-binding compound or composition, and melatonin, wherein said melatonin is administered at or near the patient'"'"'s normal bedtime.

2. The method according to claim 1, wherein said estrogen is selected from the group consisting of 17β

-estradiol, estrone, estriol, ethinyl estradiol and conjugated equine estrogens.

3. The method according to claim 1, wherein said progesterone-receptor-binding-compound or composition is selected from the group consisting of progesterone, medroxyprogesterone acetate;

levonorgestrel, norethindrone, norethindrone acetate, and norgestimate.

4. The method according to claim 1, wherein said estrogen is 17β

-estradiol, said progesterone-receptor-binding compound or composition is progesterone, and wherein said 17β

-estradiol is administered via oral route of administration to said patient in the amount of 0.1-0.9 mg per day, said progesterone is administered via oral route of administration to said patient in the amount of 10-90 mg per day and further wherein said melatonin is administered via oral route of administration in a dose of between 1-9 mg per day.

5. A pharmaceutical composition in unit dosage form, comprising 0.1-0.9 mg 17β

-estradiol and 10-90 mg progesterone, and at least one pharmaceutically acceptable diluent or excipient.

6. The pharmaceutical composition according to claim 5 wherein said dosage form includes 1-9 mg melatonin.

7. The pharmaceutical dosage form according to claim 6 wherein said dosage form contains 0.5 mg 17β

-estradiol (E₂), 50 mg of progesterone (P₄) and 5 mg melatonin.

8. A pharmaceutical composition in unit dosage form, comprising about 2-6 mg melatonin and a pharmaceutically active amount of each of 17β

-estradiol and levonorgestrel, wherein the ratio by weight inclusion of 17β

-estradiol to levonorgestrel is about 5.5;

1 to 6.5;

1, together with at least one pharmaceutically acceptable excipient or diluent.

9. The pharmaceutical composition according to claim 8, where the ratio by weight inclusion of 17β

-estradiol to levonorgestrel is about 6;

1.

10. A pharmaceutical composition in unit dosage form, comprising about 2-6 mg melatonin and a pharmaceutically effective amount of each of conjugated equine estrogens (CEE) and medroxyprogesterone acetate (MPA) wherein the ratio by weight of CEE to MPA is about 1:

2-2.5.

11. The pharmaceutical composition according to claim 10 wherein the ratio by weight of CEE to MPA is about 1:

2.

12. A method of preventing or treating mammary cancer in a patient in need of said prevention or treatment, comprising administering in unit dosage form a hormone selected from the group consisting of an estrogen and a progesterone-receptor-binding compound or composition, together with a quantity of melatonin, wherein at least said melatonin is administered at or near the patient'"'"'s normal bedtime.