# US 2019/0314458 A1 · Methods of treating hormonal disorders associated with androgen deficiency using a repeat microflare dosing regimen > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2019/0314458 A1 - Document ID: US20190314458A1 - Status: Published application - Kind: A1 - Application number: 16/379,434 - Filed: 2019-04-09 - Published: 2019-10-17 - Earliest claimed: 2018-04-13 - Inventors: Pieter Muntendam - Web page: https://patentgrep.com/patent/US20190314458A1 ## CPC - A61K 38/22: Hormones (derived from pro-opiomelanocortin, pro-enkephalin or pro-dynorphin A61K38/33, e.g. corticotropin A61K38/35) - A61K 31/4178: not condensed 1,3-diazoles and containing further heterocyclic rings, e.g. pilocarpine, nitrofurantoin - 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) ## Abstract A method of treating a hormonal disorder associated with androgen deficiency is disclosed. The method includes administering a therapeutically effective dose of a composition having a GnRH agonist to a subject in need thereof. The therapeutically effective dose is sufficient to support a first flare of hormones. The method further includes allowing a time interval after the administration of the dose. The time interval is sufficient to support pituitary-gonadal axis recovery. The method further includes administering at least one subsequent dose of the composition to the subject after the time interval. The subsequent dose is sufficient to support a microflare of hormones that is less than, or equal to, a magnitude of the first microflare. Subsequent doses spaced by the time interval resulting in a repeat microflare sufficient to chronically elevate hormone levels and provide relief of signs or symptoms of androgen deficiency. ## Claims ### Claim 1 A method of treating a hormonal disorder associated with androgen deficiency, the method comprising: (a) administering to a subject in need thereof, a therapeutically effective dose of a composition having a gonadotropin-releasing hormone (GnRH) agonist, wherein the therapeutically effective dose is sufficient to support a first flare of hormones; (b) allowing a time interval after the administration, wherein the time interval is sufficient to support pituitary-gonadal axis recovery; and (c) administering to the subject, at least one subsequent dose of the composition after the time interval, wherein the subsequent dose is sufficient to support a microflare of hormones that is less than, or equal to, a magnitude of the first flare, the combination of flare and repeat microflares resulting in an improvement of symptoms of androgen deficiency. ### Claim 2 (depends on 1) The method of claim 1, wherein the disorder associated with the androgen deficiency comprises hypogonadotropic hypogonadism (HH). ### Claim 3 (depends on 2) The method of claim 2, wherein the hypogonadotropic hypogonadism is Kallmann syndrome. ### Claim 4 (depends on 1) The method of claim 1, wherein the disorder comprises androgen deficiency in aging male (ADAM). ### Claim 5 (depends on 4) The method of claim 4, wherein symptoms of the ADAM comprises fatigue, depression, decreased sexual libido, sexual dysfunction, erectile dysfunction, hypogonadism, and alterations in mood and cognition. ### Claim 6 (depends on 1) The method of claim 1, wherein the GnRH agonist comprises at least one of, buserelin, deslorelin, fertirelin, gonadorelin, goserelin, histrelin, leuprorelin, nafarelin, triptorelin, GnRH agonist derivatives, optical isomers, pharmaceutically acceptable salts, formulations, hydrates, and a combination thereof. ### Claim 7 (depends on 1) The method of claim 1 further comprising, adjusting the subsequent dose and the time interval to maintain hormone levels in the subject within a desired range. ### Claim 8 (depends on 1) The method of claim 1, wherein the hormones comprise testosterone, androstenedione and intermediates and derivatives thereof. ### Claim 9 (depends on 1) The method of claim 1, wherein the hormone is testosterone. ### Claim 10 (depends on 1) The method of claim 1 further comprising, individualizing the time interval and the subsequent dose based on a test treatment. ### Claim 11 (depends on 10) The method of claim 10 further comprising, individualizing the time interval and the subsequent dose based on at least one of, hormonal assessment, symptoms, laboratory testing and physical assessment. ### Claim 12 (depends on 10) The method of claim 10 further comprising, periodically adjusting the subsequent dose and the time interval based on treatment response. ### Claim 13 (depends on 1) The method of claim 1 further comprising, administering the GnRH agonist to the subject via at least one of, subcutaneous, oral, topical, rectal, intramuscular, transdermal, intranasal, inhalation and buccal administration. ### Claim 14 (depends on 1) The method of claim 1 further comprising, administering the GnRH agonist with an absorption enhancer.