EP1052980A1 - Subkutane verabreichung von medroxyprogesteronacetat zur behandlung von klimakterischer beschwerden und endometriose - Google Patents

Subkutane verabreichung von medroxyprogesteronacetat zur behandlung von klimakterischer beschwerden und endometriose

Info

Publication number
EP1052980A1
EP1052980A1 EP99970317A EP99970317A EP1052980A1 EP 1052980 A1 EP1052980 A1 EP 1052980A1 EP 99970317 A EP99970317 A EP 99970317A EP 99970317 A EP99970317 A EP 99970317A EP 1052980 A1 EP1052980 A1 EP 1052980A1
Authority
EP
European Patent Office
Prior art keywords
female
effective amount
progestogen
medroxyprogesterone acetate
human
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP99970317A
Other languages
English (en)
French (fr)
Inventor
Hendrik J. De Koning Gans
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Pharmacia and Upjohn Co
Original Assignee
Pharmacia and Upjohn Co
Upjohn Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Pharmacia and Upjohn Co, Upjohn Co filed Critical Pharmacia and Upjohn Co
Publication of EP1052980A1 publication Critical patent/EP1052980A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
    • A61K31/57—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/12—Drugs for genital or sexual disorders; Contraceptives for climacteric disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P15/00—Drugs for genital or sexual disorders; Contraceptives
    • A61P15/18—Feminine contraceptives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/30—Oestrogens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P5/00—Drugs for disorders of the endocrine system
    • A61P5/24—Drugs for disorders of the endocrine system of the sex hormones
    • A61P5/34—Gestagens

Definitions

  • the present invention is a subcutaneous method for administering a progestogen or a progestogen and an estrogen tor female contraceptn e use or for female menopause treatment
  • the present invention is also a method for subcutaneous administration of a progestogen for the treatment of endomet ⁇ osis
  • the J Reprod Fertil . 15, 209-14 (1968) discloses a clinical study of medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg) by monthly IM injection for female contraception in 104 women over a period of from tour to 15 mo with no pregnancies Following each IM injection there is a contraceptive effect for a one month time period following which the female has a menstrual period Contraception, 56, 353- 359 ( 1997) also discloses a clinical study of medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg) by monthly LM injection tor temale contraception
  • 4.826,831 discloses a method of hormonal treatment of menopausal women using either a progestogen, including medroxyprogesterone acetate and estrogen by oral or intramuscular injection as well as by an implantable composition
  • Endomet ⁇ osis is the presence and growth of endomet ⁇ al tissue outside the internal uterine lining It is know to those skilled in the art that progestogens can be administered orally to treat this condition The present invention does not use oral administration
  • the method of the present invention can be practiced by the female patient herself administering the subcutaneous injection herself
  • the patient should be taught by a trained health care professional how to administer the subcutaneous injection of progestogen or progestogen plus estrogen
  • the patient then injects subcutaneously a contraceptively effective amount as she was directed either approximately once a month or approximately every three months or approximately every six months
  • the word approximately is used because some months have 30 days while others have 31 days
  • There are two ways to practice the claimed invention are either the administration of a progestogen alone or the combination of a progestogen with an estrogen When administering the progestogen alone it is administered either once a month, or up to approximately every six months or any interval in between, depending on the dose
  • progestogen alone method she will not have a menstrual period during that time
  • progestogen alone method it is preferred that the female administer the subcutaneous injection
  • US Patent 4,038,389 discloses a 200-600 mg/ml parenteral formulation of medroxyprogesterone acetate.
  • the 1996 Physicians Desk Reference (PDR), pages 2602- 2604, discloses a sterile aqueous suspension of medroxyprogesterone acetate (DEPO- PROVERA) for depot IM administration for female contraception containing 150 mg of medroxyprogesterone acetate/ml.
  • the parenteral formulation can be administered once every month or every 13 weeks (3 months) or every 26 weeks (6 months). Following the contraceptive period, the female has a menstrual period unless she has another EM injection prior to her period.
  • the female may have a series of EM injections of medroxyprogesterone acetate to provide contraception on a continuous basis.
  • the J. Reprod. Fertil, 15, 209-14 (1968) discloses a formulation of medroxyprogesterone acetate (25 mg) and estradiol cypionate (5 mg) which was used in a clinical study by monthly IM injection for female contraception. See also Contraception, 49, 293-301 (1994) at 296 and Contraception, 56, 353-359 (1997) at 353.
  • the progestogen be selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norgestrel it is more preferred that the progestogen be medroxyprogesterone acetate.
  • the estrogen be selected from the group consisting of ethinyl estradiol, estradiol cypionate and estradiol valerate; it is more preferred that the estrogen be estradiol cypionate.
  • the contraceptive agent be medroxyprogesterone acetate or medroxyprogesterone acetate plus estradiol cypionate.
  • the contraceptive method of the present invention is practiced by using a progestogen alone, it is preferred that the progestogen be in a depot form as is well known to those skilled in the art. It is preferred that the contraceptively effective amount for one month be for medroxyprogesterone acetate from about 10 mg to about 50 mg/female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg/female, for levo- norgrestrel from about 0.5 mg to about 2 mg/female; for three months be for medroxyprogesterone acetate from about 50 mg to about 200 mg/female.
  • progesterone from about 25 mg to about 200 mg/female.
  • for northindrone from about 5 mg to about 50 mg/female
  • desogestrel from about 1 mg to about 4 mg/female.
  • levo-norgrestrel from about 0.5 mg to about 2 mg/female and for six months be for medroxyprogesterone acetate from about 100 mg to about 500 mg/female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg/female, for levo-norgrestrel from about 0.5 mg to about 2 mg/female.
  • the dose for one, three and six monthes be from about 20 mg to about 30 mg female, from about 75 mg to about 175 mg/female and from about 150 mg to about 300 mg/female.
  • the medroxyprogesterone acetate dose is from about 100 mg to about 200 mg/female; at six months the medroxyprogesterone acetate dose is from about 200 mg to about 500 mg/female.
  • the medroxyprogesterone acetate dose for three months be from about 125 mg to about 175 mg/female and for six months from about 250 mg to about 300 mg/female.
  • the contraceptive method of the present invention is practice by using a progestogen plus an estrogen once a month
  • the progestogen and estrogen should be in a formulation suitable for subcutaneous administration as is known to those skilled in the art.
  • the contraceptively effective amount be: for medroxyprogesterone acetate from about 10 mg to about 50 mg/female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg/female, for levo-norgrestrel from about 0.5 mg to about 2 mg/female.
  • estradiol cypionate from about 2.5 mg to about 20 mg/female, ethinyl estradiol from about 0.5 mg to about 3 mg/female, estradiol valerate from about 2.5 mg to about 20 mg/female. It is preferred the contraceptively effective amount of medroxyprogesterone acetate is from about 20 mg to about 30 mg/female and the contraceptively effective amount of estradiol cypionate is from about 3 to about 10 mg/female.
  • the present invention is a method of human female menopause treatment which comprises subcutaneous administration of a menopausely effective amount of a hormonal replacement agent selected from the group consisting of a progestogen and a progestogen plus an estrogen.
  • the method of the present invention can be practiced by the female patient herself administering the subcutaneous injection herself.
  • the patient should be taught by a trained health care professional how to administer the subcutaneous injection of progestogen or progestogen plus estrogen.
  • the patient then injects subcutaneously a menopausely effective amount as she was directed either approximately once a month or approximately every three months or approximately every six months.
  • the word "approximately” is used because some months have 30 days while _ others have 31 days.
  • the female administer the subcutaneous injection either approximately every three or approximately every six months.
  • the method of the present invention can be practiced by the administration of a combination of a progestogen plus an estrogen once a month. When this method is utilized the female will have a menstrual period every month.
  • the progestogen be selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norgestrel it is more preferred that the progestogen be medroxyprogesterone acetate.
  • the estrogen be selected from the group consisting of ethinyl estradiol, estradiol cypionate and estradiol valerate; it is more preferred that the estrogen be estradiol cypionate.
  • the hormonal replacement agent be medroxyprogesterone acetate or medroxyprogesterone acetate plus estradiol cypionate.
  • the progestogen be in a depot form as is well known to those skilled in the art. It is preferred that the menopausely effective amount for one month be for medroxyprogesterone acetate from about 10 mg to about 50 mg/female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg/female, for levo- norgrestrel from about 0.5 mg to about 2 mg/female; for three months be for medroxyprogesterone acetate from about 50 mg to about 200 mg/female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg female, for levo-norg
  • the dose for one, three and six monthes be from about 20 mg to about 30 mg/female, from about 75 mg to about 175 mg/female and from about 150 mg to about 300 mg/female.
  • the medroxyprogesterone acetate dose is from about 100 mg to about 200 mg/female; at six months the medroxyprogesterone acetate dose is from about 200 mg to about 500 mg female.
  • the medroxyprogesterone acetate dose for three months be from about 125 mg to about 175 mg/female and for six months from about 250 mg to about 300 mg/female.
  • the progestogen and estrogen should be in a formulation suitable for subcutaneous administration as is known to those skilled in the art. It is preferred that the menopausely effective amount be: for medroxyprogesterone acetate from about 10 mg to about 50 mg/female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg/female, for levo-norgrestrel from about 0.5 mg to about 2 mg/female.
  • the menopausely effective amount of estrogen is: for estradiol cypionate from about 2.5 mg to about 20 mg/female, ethinyl estradiol from about 0.5 mg to about 3 mg/female, estradiol valerate from about 2.5 mg to about 20 mg/female. It is preferred the menopsausely effective amount of medroxyprogesterone acetate is from about 20 mg to about 30 mg/female and the menopausely effective amount of estradiol cypionate is from about 3 to about 10 mg/female.
  • Another aspect of the present invention is a method of treating endometriosis in a human female who is in need of such treatment which comprises subcutaneous administration of a endometrially effective amount of a progestogen.
  • the method of the present invention can be practiced by the female patient herself administering the subcutaneous injection herself.
  • the patient should be taught by a trained health care professional how to administer the subcutaneous injection of progestogen.
  • the patient then injects subcutaneously an endometrially effective amount as she was directed either approximately once a month or approximately every three months or approximately every six months.
  • the word "approximately” is used because some months have 30 days while others have 31 days.
  • administering the progestogen it is administered either once a month, or approximately every three months or approximately every six months.
  • the progestogen be selected from the group consisting of medroxyprogesterone acetate, progesterone, norethindrone, desogestrel and levo-norgestrel it is more preferred that the progestogen be medroxyprogesterone acetate.
  • the progestogen be in a depot form as is well known to those skilled in the art.
  • the endometrially effective amount for one month be for medroxyprogesterone acetate from about 10 mg to about 50 mg/female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg/female, for levo-norgrestrel from about 0.5 mg to about 2 mg/female; for three months be for medroxyprogesterone acetate from about 50 mg to about 200 mg female, for progesterone from about 25 mg to about 200 mg/female, for northindrone from about 5 mg to about 50 mg/female, for desogestrel from about 1 mg to about 4 mg/female, for levo-norgrestrel from about 0.5 mg to about 2 mg/female and for six months be for medroxyprogesterone acetate from about 100 mg to about 500 mg/female, for progesterone a
  • the dose for one, three and six months be from about 20 mg to about 30 mg/female. from about 75 mg to about 175 mg/female and from about 150 mg to about 300 mg/female.
  • the medroxyprogesterone acetate dose is from about 100 mg to about 200 mg/female; at six months the medroxyprogesterone acetate dose is from about 200 mg to about 500 mg/female.
  • the medroxyprogesterone acetate dose for three months be from about 125 mg to about 175 mg/female and for six months from about 250 mg to about 300 mg/female.
  • the exact dosage and frequency of administration of the progestogen or progestogen plus estrogen for contraception, menopause or endometriosis treatment depends on the age, weight, general physical condition of the particular patient, other medication the individual may be taking as is well known to those skilled in the art and can be more accurately determined by measuring the blood level or concentration of the progestogen or progestogen and estrogen in the patient's blood and/or the patient's response to the particular condition being treated.
  • Medroxyprogesterone acetate refers to 17 ⁇ -hydroxy-6 ⁇ -methylpregn-4-ene-3,20- dione 17-acetate.
  • EM refers to intramuscular injection.
  • Menopause refers to, and includes, premenopause, menopause and postmenopause.
  • a 60 kg 23 year old female who desires to have sexual intercourse on a regular basis is shown how to give a subcutaneous injection by her physician. She injects 0.2 ml of a 100 mg/ml of an aqueous suspension of medroxyprogesterone acetate subcutaneous as instructed on the third day of her menstrual period. She has sexual intercourse twice a week with a fertile male and does not become pregnant.
  • a 78 kg 37 year old female who desires to have sexual intercourse on a regular basis is shown how to give a subcutaneous injection by her physician's nurse. She injects 1.0 ml of a 125 mg/ml of an aqueous suspension of medroxyprogesterone acetate subcutaneous as instructed on the second day of her menstrual period. She has sexual intercourse three times a week with a fertile male and does not become pregnant.
  • a 67 kg 21 year old female who desires to have sexual intercourse on a regular basis is shown how to give a subcutaneous injection by her gynecologist. She injects 1.0 ml of a
  • a 71 kg 40 year old female who desires to have sexual intercourse on a regular basis is shown how to give a subcutaneous injection by her physician ' s nurse. She injects 0.5 ml of an aqueous suspension containing 20 mg medroxyprogesterone acetate and 7.0 mg estradiol cypionate as instructed on the second day of her menstrual period. She has sexual intercourse three times a week with a fertile male and does not become pregnant.

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  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Endocrinology (AREA)
  • Organic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Reproductive Health (AREA)
  • Diabetes (AREA)
  • Gynecology & Obstetrics (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
EP99970317A 1998-10-09 1999-10-06 Subkutane verabreichung von medroxyprogesteronacetat zur behandlung von klimakterischer beschwerden und endometriose Withdrawn EP1052980A1 (de)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US10369998P 1998-10-09 1998-10-09
US103699P 1998-10-09
US12682499P 1999-03-30 1999-03-30
US126824P 1999-03-30
PCT/US1999/020904 WO2000021511A2 (en) 1998-10-09 1999-10-06 Subcutaneous medroxyprogesterone acetate for treatment of menopause and endometriosis

Publications (1)

Publication Number Publication Date
EP1052980A1 true EP1052980A1 (de) 2000-11-22

Family

ID=26800754

Family Applications (1)

Application Number Title Priority Date Filing Date
EP99970317A Withdrawn EP1052980A1 (de) 1998-10-09 1999-10-06 Subkutane verabreichung von medroxyprogesteronacetat zur behandlung von klimakterischer beschwerden und endometriose

Country Status (6)

Country Link
EP (1) EP1052980A1 (de)
JP (1) JP2002527380A (de)
AU (1) AU1197100A (de)
BR (1) BR9906862A (de)
CA (1) CA2311937A1 (de)
WO (1) WO2000021511A2 (de)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2521471A1 (en) * 2003-04-11 2004-10-28 Barr Laboratories, Inc. Methods of administering estrogens and progestins
JP5651279B2 (ja) * 2003-09-03 2015-01-07 ミスコン トレイディング エス．エー． 子宮内膜症の処置のための方法
US20080306034A1 (en) * 2007-06-11 2008-12-11 Juneau Biosciences, Llc Method of Administering a Therapeutic
UY33103A (es) * 2009-12-15 2011-07-29 Techsphere S A De C V Formulacion farmaceutica parenteral en suspension, de liberacion sostenida, en dosis baja y ultra baja, en terapia hormonal en el sindrome climaterico
US10881659B2 (en) 2013-03-15 2021-01-05 Abbvie Inc. Methods of treating heavy menstrual bleeding
CN112261942A (zh) * 2018-04-19 2021-01-22 艾伯维公司 治疗重度月经出血的方法
WO2019220189A1 (en) * 2018-05-18 2019-11-21 Hafeez Kalak Abdul Drug delivery system comprising medroxyprogesterone acetate for use in female contraception

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SU724127A1 (ru) * 1977-02-10 1980-03-30 Всесоюзный Научно-Исследовательский Институт Акушерства И Гинекологии Способ определени функции ичников
SU686736A1 (ru) * 1977-02-10 1979-09-25 Всесоюзный Научно-Исследовательский Институт Акушерства И Гинекологии Способ лечени эндокринных гинекологических заболеваний
US4826831A (en) * 1983-08-05 1989-05-02 Pre Jay Holdings Limited Method of hormonal treatment for menopausal or post-menopausal disorders involving continuous administration of progestogens and estrogens
ZA924811B (en) * 1991-06-28 1993-12-29 Endorecherche Inc Controlled release systems and low dose androgens
HU222501B1 (hu) * 1991-06-28 2003-07-28 Endorecherche Inc. MPA-t vagy MGA-t tartalmazó nyújtott hatóanyag-felszabadulású gyógyászati készítmény és eljárás előállítására

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO0021511A2 *

Also Published As

Publication number Publication date
WO2000021511A2 (en) 2000-04-20
JP2002527380A (ja) 2002-08-27
WO2000021511A3 (en) 2000-11-30
BR9906862A (pt) 2001-11-27
CA2311937A1 (en) 2000-04-20
AU1197100A (en) 2000-05-01

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