WO2006042561A2 - Intrauterine contraceptive system with copper and progesterone - Google Patents

Intrauterine contraceptive system with copper and progesterone Download PDF

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Publication number
WO2006042561A2
WO2006042561A2 PCT/EG2004/000041 EG2004000041W WO2006042561A2 WO 2006042561 A2 WO2006042561 A2 WO 2006042561A2 EG 2004000041 W EG2004000041 W EG 2004000041W WO 2006042561 A2 WO2006042561 A2 WO 2006042561A2
Authority
WO
WIPO (PCT)
Prior art keywords
copper
pro
progesterone
norgestrel
intrauterine contraceptive
Prior art date
Application number
PCT/EG2004/000041
Other languages
French (fr)
Other versions
WO2006042561A3 (en
Inventor
Mohamed Ezz El Din Azzam
Original Assignee
Mohamed Ezz El Din Azzam
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 Mohamed Ezz El Din Azzam filed Critical Mohamed Ezz El Din Azzam
Priority to PCT/EG2004/000041 priority Critical patent/WO2006042561A2/en
Publication of WO2006042561A2 publication Critical patent/WO2006042561A2/en
Publication of WO2006042561A3 publication Critical patent/WO2006042561A3/en

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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
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
    • A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
    • A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
    • A61F6/142—Wirelike structures, e.g. loops, rings, spirals
    • A61F6/144—Wirelike structures, e.g. loops, rings, spirals with T-configuration
    • 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
    • A61K31/565—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
    • A61K31/567—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol substituted in position 17 alpha, e.g. mestranol, norethandrolone

Definitions

  • Intrautrine contraceptive devices are either Copper or hormone releasing. Copper devices are used internationally on a wide scale. However side effects are many including bleeding and anaemia A pregnancy rate of 1-2 HWY Pain etc.
  • hormone releasing IU system known as Levo-Nova or mirena is use on relatively limited scales in Europe and on other countries.lt has got many health benifites including deminution of blood loss and improvement of anaemia ,very low failure rate(pregnancy rate is less than 0.02 H. W. Y. ) less pain,prevention of endometrial cancer ,less infection., etc .It releases 20 microgm/ day of Levorgestrel for 5 years however systemic side effect and amenrrhea are frequent.
  • Pro-Copper or Azzam IUCD is a combination of both Copper and
  • L.Norgestrel380A (1) is used as a carrier to a tube of 9 mm length
  • Pro-Copper (2) containing both the L.Norgestrel hormone 18 mg in Pro-Copper I and 25 mg in Pro-Copper II and the medical grade silicone rubber This means that Pro-Copper contains 1/3-1/2 L.Norgestrel as that of mirena
  • the Pro-Copper is documented to combine the benefits of both Copper T devices as well as hormone releasing device Levo- Nova (mirena) .
  • the side effect of L.Norgestrel is much less as expected
  • the Pro-Copper (AZZAM IUCD) is the only which contains both Copper and hormone in the world literature with clinical and laboratory work for over 10 years.
  • Adding a progestogen (eg.l.norgestrel) to copper containing IUCD is a new concept started by Dr.Azzam.
  • the amount of norgestrel in the pro-copper is only 1/3-1/2 that present in Levo-Nova which releases 20 microgm / day,which causes amenorrhea and hypomenrrhea in a large percentage of women also there are some general manifestations of this relatively large amount of the hormone .
  • the hormone is mixed in medical grade silicone rubber for sustained and slow release .
  • the Pro-Copper I&II contains different amounts of L.Norgestel the Pro-Copper I contains 18 mg & releases 7 microgm daily for five years while Pro-Copper Il contains 25 mg L.Norgestel releasing 10 microgm /day for 5 years .

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  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Reproductive Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

The invention concerns a contraceptive intrauterine device. The active substances are copper and a steroid of the progesterone family.

Description

Pro-Copper (IUCDs) IJI.Azzam IUCDs
Technical Field
An Intra utrine system for contraception and treatment of dysfunctional menorrhagia
Background Art
Intrautrine contraceptive devices are either Copper or hormone releasing. Copper devices are used internationally on a wide scale. However side effects are many including bleeding and anaemia A pregnancy rate of 1-2 HWY Pain etc.
On the other hand hormone releasing IU system known as Levo-Nova or mirena is use on relatively limited scales in Europe and on other countries.lt has got many health benifites including deminution of blood loss and improvement of anaemia ,very low failure rate(pregnancy rate is less than 0.02 H. W. Y. ) less pain,prevention of endometrial cancer ,less infection., etc .It releases 20 microgm/ day of Levorgestrel for 5 years however systemic side effect and amenrrhea are frequent.
Pro-Copper or Azzam IUCD is a combination of both Copper and
L.Norgestrel380A (1) is used as a carrier to a tube of 9 mm length
(2) containing both the L.Norgestrel hormone 18 mg in Pro-Copper I and 25 mg in Pro-Copper II and the medical grade silicone rubber This means that Pro-Copper contains 1/3-1/2 L.Norgestrel as that of mirena The Pro-Copper is documented to combine the benefits of both Copper T devices as well as hormone releasing device Levo- Nova (mirena) .The side effect of L.Norgestrel is much less as expected It should be emphasized that the Pro-Copper (AZZAM IUCD) is the only which contains both Copper and hormone in the world literature with clinical and laboratory work for over 10 years.
Disclosure of invention
Adding a progestogen (eg.l.norgestrel) to copper containing IUCD is a new concept started by Dr.Azzam.
The theoritcal advantages of these two active ingredients are: -Increasing the efficacy i.e. rninirnizing pregnancy grate.
-Minimizing the side effect of both copper and hormone releasing IUCD's.
The amount of norgestrel in the pro-copper is only 1/3-1/2 that present in Levo-Nova which releases 20 microgm / day,which causes amenorrhea and hypomenrrhea in a large percentage of women also there are some general manifestations of this relatively large amount of the hormone .
In Pro-Copper the small amount of L.Norgestrel allows the reduction of menstrual flow but not to the extent of amenorrhea beside minimal side effects
As a result of laboratory and clinical work over the past 10 years including 8 master and M. D. degrees at Ain Shams , Alexandria and Banha universities as well as 6 published papers ,it is now established that Pro-copper has definitely the following advantages :
1-very high efficacy rate less than 0.01 pregnancy /H. W. Y.
2-Diminished menstrual flow after initial period of spotting in 30- 40% of women .
3 -Improved dysmenorrhea .
4- very low rate of P. I. D. as a result of decreased menstruation and thick cervical mucus.
5- Documented labratory findings of decreased prevalence of aerobic and anearobrc organisns both intra uterine and cervical as well as lower rate of bacterial vaginosis compare to Copper IUCD. 6-No interference with absorption of copper. It is very encouraging that the Pro-Copper was selected by the academy of Scientific research as the best medical achievement in egypt for the Award of the Instritute of African Nations.
The hormone is mixed in medical grade silicone rubber for sustained and slow release .The Pro-Copper I&II contains different amounts of L.Norgestel the Pro-Copper I contains 18 mg & releases 7 microgm daily for five years while Pro-Copper Il contains 25 mg L.Norgestel releasing 10 microgm /day for 5 years .This gives the clinician better chance for selection of Pro-Copper most convenient for particular woman .This will increases the compliance and minimizes more the side effects .Clinical trials at different universities in Egypt (phase HI studies ) have confirmed their high efficacy safety and many health benifits including improvment of anaemia .less bacterial vagionsis ,less bleeding,less pregnancy rate ,less pelvic pain see tables below.
Brief Description of drawing:
A copper - T 38/0 A (I) with a 9 mm tube made of medical grade silicone with impregnated Levo norgestrel hormone (2), the Naylon thread of the I.U.C.D. (3)

Claims

Claims
1- World wide this is the 1st IU system containing both Copper and LevoNorgestrel.
Adding a Progestogen e.g. LevoNorgestrel to Copper in manifacturing intra uterine system of contraception and treatment dysfuctional menorrhagia
2- The use L.Norgestrel in different quantities to suit different women (different doses)
3- The use of other progestogens added to Copper devices .
PCT/EG2004/000041 2004-10-20 2004-10-20 Intrauterine contraceptive system with copper and progesterone WO2006042561A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/EG2004/000041 WO2006042561A2 (en) 2004-10-20 2004-10-20 Intrauterine contraceptive system with copper and progesterone

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/EG2004/000041 WO2006042561A2 (en) 2004-10-20 2004-10-20 Intrauterine contraceptive system with copper and progesterone

Publications (2)

Publication Number Publication Date
WO2006042561A2 true WO2006042561A2 (en) 2006-04-27
WO2006042561A3 WO2006042561A3 (en) 2006-06-22

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EG2004/000041 WO2006042561A2 (en) 2004-10-20 2004-10-20 Intrauterine contraceptive system with copper and progesterone

Country Status (1)

Country Link
WO (1) WO2006042561A2 (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10159596B2 (en) 2012-08-14 2018-12-25 Sebela Vlc Limited Intrauterine contraceptive device
US10166141B2 (en) 2012-08-14 2019-01-01 Sebela Vlc Limited Intrauterine contraceptive device
US10188546B2 (en) 2013-10-14 2019-01-29 Sebela Vlc Limited Intrauterine device with controlled copper ion elution
US10918516B2 (en) 2013-10-14 2021-02-16 Sebela Vlc Limited Intrauterine device with controlled copper ion elution

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0117163A1 (en) * 1983-01-07 1984-08-29 Marc Levrier Contraceptive and therapeutic introuterine device combining copper, natural progesterone and amino-iso caproic acid
DE4125575A1 (en) * 1991-08-02 1995-04-20 Piening Wolf Dietrich Dr Med Intrauterine pessary
WO2000067684A1 (en) * 1999-05-07 2000-11-16 Dirk Wildemeersch Intrauterine contraceptive device

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0117163A1 (en) * 1983-01-07 1984-08-29 Marc Levrier Contraceptive and therapeutic introuterine device combining copper, natural progesterone and amino-iso caproic acid
DE4125575A1 (en) * 1991-08-02 1995-04-20 Piening Wolf Dietrich Dr Med Intrauterine pessary
WO2000067684A1 (en) * 1999-05-07 2000-11-16 Dirk Wildemeersch Intrauterine contraceptive device

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10159596B2 (en) 2012-08-14 2018-12-25 Sebela Vlc Limited Intrauterine contraceptive device
US10166141B2 (en) 2012-08-14 2019-01-01 Sebela Vlc Limited Intrauterine contraceptive device
US10932943B2 (en) 2012-08-14 2021-03-02 Sebela Vlc Limited Intrauterine contraceptive device
US11850181B2 (en) 2012-08-14 2023-12-26 Sebela Vlc Limited Intrauterine contraceptive device
US10188546B2 (en) 2013-10-14 2019-01-29 Sebela Vlc Limited Intrauterine device with controlled copper ion elution
US10918516B2 (en) 2013-10-14 2021-02-16 Sebela Vlc Limited Intrauterine device with controlled copper ion elution

Also Published As

Publication number Publication date
WO2006042561A3 (en) 2006-06-22

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