Compositions and methods for the prophylaxis and treatment of dysmenorrhea, endometriosis, and pre-term labor, using histidine
AssigneeCytos Pharamaceuticals, LLC
InventorsJohn Peterson, Peter G. Thomas
Life of this patent
Estimating the term…
Abstract
The present invention relates to methods and compositions for preventing or treating conditions or disorders of the female reproductive system by administering an effective dosage of histidine alone or in combination with other therapeutic agents. The invention relates also to novel physical compositions and delivery devices for administering histidine effectively to a female subject in need of either prophylaxis or treatment of certain disorders of the reproductive system.
Claims61
A method for preventing the onset of dysmenorrhea or treating the sequelae thereof in a human female, said method comprising administering to said human female at a time prior to menses or at commencement thereof, or both, an amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, that is effective to prevent onset of dysmenorrhea or to treat the sequelae thereof, in conjunction with at least one pharmacologically acceptable carrier.
The method according to 3 wherein said step of administering histidine comprises vaginally administering a prophylactically or therapeutically effective amount of said histidine in conjunction with a bioadhesive crosslinked carboxylic acid polymer as a sustained release carrier.
The method according to claim I further comprising co-administering a second compound which is a therapeutic agent for preventing or treating dysmenorrhea other than histidine, and wherein said second compound is efficaciously co-administered in an amount which is less than an pharmacologically recommended dose for said second compound when administered alone.
A method for treating pelvec pain from endometriosis in a human female, comprising administering to said human female an amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, that is effective to alleviate said pelvic pain, in conjunction with at least one pharmacologically acceptable carrier.
A method for preventing onset of or controlling a pre-term labor in a pregnant woman, comprising administering to said pregnant woman an amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, that is effective to prevent, or control by extending to substantially full-term, a pre-term labor, in conjunction with at least one pharmacologically acceptable carrier.
The method according to 26 wherein said step of administering histidine comprises vaginally administering a therapeutically effective amount of said histidine in conjunction with a bioadhesive crosslinked carboxylic acid polymer as a sustained release carrier.
The method according to 26 wherein said step of administering histidine comprises vaginally administering a therapeutically effective amount of said histidine in conjunction with a bioadhesive crosslinked carboxylic acid polymer as a sustained release carrier.
A method for preventing or treating pre-menstrual and menstrual cramping in a woman, comprising administering either before onset of menses or at commencement thereof, or both, a prophylactically or therapeutically effective amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, in conjunction with at least one pharmacologically acceptable carrier.
The method according to 38 wherein said step of administering histidine comprises vaginally administering a prophylactically or therapeutically effective amount of said histidine in conjunction with a bioadhesive crosslinked carboxylic acid polymer as a sustained release carrier.
The method according to 36 wherein said step of administering histidine comprises vaginally administering a therapeutically effective amount of said histidine in conjunction with a bioadhesive crosslinked carboxylic acid polymer as a sustained release carrier prior to and during menstruation.
A method for preventing or controlling a pre-term labor in an insulin-resistant pregnant woman, comprising administering to said insulin-resistant pregnant woman A) an amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, that is effective to prevent, or control by extending to substantially full-term, said pre-term labor and B) an effective amount of D-chiroinositol, in conjunction with at least one pharmacologically acceptable carrier.
A composition of matter for preventing or treating dysmenorrhea and sequelae thereof in a human female, comprising one of an intravaginal device or an intrauterine device containing a releasable prophylactically or therapeutically effective amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof.
A composition for treating endometriosis and sequelae thereof comprising A) a therapeutically effective amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, B) an effective amount of a hormone therapeutic selected from the group consisting of danazol, a gonadotropin releasing hormone analogue, and an oral contraceptive, and pharmacologically acceptable carrier therefor.
A composition for treating a woman afflicted with polycystic ovary syndrome, comprising A) a therapeutically effective amount of D-histidine, L-histidine, a herapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, B) an ovulation-restoring effective amount of D-chiroinositol, and pharmacologically acceptable carrier therefor.
A composition for preventing onset of or for treating dysmenorrhea in a human female, comprising A) an effective amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, B) an amount of a prostaglandin synthetase inhibitor which is less than a pharmacologically recommended dose for said prostaglandin synthetase inhibitor when administered alone and which amount is efficacious when co-administered with said histidine, and pharmacologically acceptable carrier therefor.
A composition for suppressing or managing pre-term labor in a pregnant female mammal comprising A) a premature labor inhibiting effective amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, B) a second active agent other than histidine and useful for controlling premature labor, present in an amount which is less than a pharmacologically recommended dose for said second active compound when administered alone, and which amount of said second active agent is efficacious when co-administered with said histidine, and a pharmacologically acceptable carrier therefor.
A composition for vaginal delivery of a prophylactic or therapeutic amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, said composition comprising a prophylactically or therapeutically effective amount of said histidine and a bioadhesive crosslinked carboxylic acid polymer as a carrier.
A treatment method for polycystic ovary syndrome and for dysmenorrhea as a sequela of said treatment in a woman, comprising co-administering to said woman an ovulation-restoring effective amount of D-chiroinositol, a therapeutically effective amount of D-histidine, L-histidine, a therapeutically acceptable salt of histidine which can be reduced to D- or L-histidine, or mixtures thereof, and at least one pharmacologically acceptable carrier.
Dependencies are inferred from the claim text.