GB2109231A - Medicament containing progesterone - Google Patents
Medicament containing progesterone Download PDFInfo
- Publication number
- GB2109231A GB2109231A GB08229804A GB8229804A GB2109231A GB 2109231 A GB2109231 A GB 2109231A GB 08229804 A GB08229804 A GB 08229804A GB 8229804 A GB8229804 A GB 8229804A GB 2109231 A GB2109231 A GB 2109231A
- Authority
- GB
- United Kingdom
- Prior art keywords
- progesterone
- group
- mammary
- percutaneous
- medicament
- 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- Withdrawn
Links
- RJKFOVLPORLFTN-LEKSSAKUSA-N Progesterone Chemical compound C1CC2=CC(=O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H](C(=O)C)[C@@]1(C)CC2 RJKFOVLPORLFTN-LEKSSAKUSA-N 0.000 title claims abstract description 80
- 229960003387 progesterone Drugs 0.000 title claims abstract description 40
- 239000000186 progesterone Substances 0.000 title claims abstract description 40
- 239000003814 drug Substances 0.000 title claims abstract description 19
- 208000006662 Mastodynia Diseases 0.000 claims abstract description 19
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 claims abstract description 7
- 208000035475 disorder Diseases 0.000 claims abstract description 7
- 206010006298 Breast pain Diseases 0.000 claims description 8
- 230000001476 alcoholic effect Effects 0.000 claims description 6
- 210000000481 breast Anatomy 0.000 claims description 6
- 230000003054 hormonal effect Effects 0.000 claims description 6
- 230000001225 therapeutic effect Effects 0.000 claims description 6
- 210000004291 uterus Anatomy 0.000 claims description 6
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims description 4
- GSEJCLTVZPLZKY-UHFFFAOYSA-N Triethanolamine Chemical compound OCCN(CCO)CCO GSEJCLTVZPLZKY-UHFFFAOYSA-N 0.000 claims description 4
- 230000008034 disappearance Effects 0.000 claims description 4
- 230000000694 effects Effects 0.000 claims description 4
- 239000000262 estrogen Substances 0.000 claims description 4
- 230000007170 pathology Effects 0.000 claims description 4
- 239000000546 pharmaceutical excipient Substances 0.000 claims description 4
- 229920000642 polymer Polymers 0.000 claims description 4
- 150000003431 steroids Chemical class 0.000 claims description 4
- 239000008213 purified water Substances 0.000 claims description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 3
- 206010003694 Atrophy Diseases 0.000 claims description 2
- 208000012641 Pigmentation disease Diseases 0.000 claims description 2
- 201000004471 adenofibroma Diseases 0.000 claims description 2
- 230000000172 allergic effect Effects 0.000 claims description 2
- 208000010668 atopic eczema Diseases 0.000 claims description 2
- 230000037444 atrophy Effects 0.000 claims description 2
- 230000002238 attenuated effect Effects 0.000 claims description 2
- 230000004888 barrier function Effects 0.000 claims description 2
- 230000008901 benefit Effects 0.000 claims description 2
- 230000004856 capillary permeability Effects 0.000 claims description 2
- 230000001413 cellular effect Effects 0.000 claims description 2
- 208000031513 cyst Diseases 0.000 claims description 2
- 230000006735 deficit Effects 0.000 claims description 2
- 230000004069 differentiation Effects 0.000 claims description 2
- 230000001079 digestive effect Effects 0.000 claims description 2
- 229940079593 drug Drugs 0.000 claims description 2
- 230000002440 hepatic effect Effects 0.000 claims description 2
- 230000006872 improvement Effects 0.000 claims description 2
- 210000005075 mammary gland Anatomy 0.000 claims description 2
- 230000005906 menstruation Effects 0.000 claims description 2
- 230000000877 morphologic effect Effects 0.000 claims description 2
- 210000004877 mucosa Anatomy 0.000 claims description 2
- 230000027758 ovulation cycle Effects 0.000 claims description 2
- 230000002688 persistence Effects 0.000 claims description 2
- 230000019612 pigmentation Effects 0.000 claims description 2
- 230000002265 prevention Effects 0.000 claims description 2
- 230000008961 swelling Effects 0.000 claims description 2
- 238000002560 therapeutic procedure Methods 0.000 claims description 2
- 230000002792 vascular Effects 0.000 claims description 2
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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0014—Skin, i.e. galenical aspects of topical compositions
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Inorganic Chemistry (AREA)
- Dermatology (AREA)
- Steroid Compounds (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
A medicament, for the treatment of mammary disorders such as mastodynias and mastopathias, is in the form of a gel containing progesterone and is administered percutaneously.
Description
SPECIFICATION
Medicament based on progesterone
The present invention relates to a medicament based on progesterone for the treatment of mammary disorders such as mastodynias and mastopathias.
This medicament is characterized in that the progesterone is in the form of gel applied by the percutaneous route.
In fact, it has been discovered, according to the invention, that progesterone, among the hormonal steroids, presents the particular feature of being metabolized in the skin into derivatives whose hormonal activity appears to be virtually zero. This results in that, when a solution of progesterone is administered by the percutaneous route, 80% of the steroids are metabolized in the skin and only 20% are capable of passing the cutaneous barrier. The percutaneous administration of progesterone therefore offers a particular advantage in mammary pathology, since it allows administration and concentration within the mammary receptor itself of a large quantity of progesterone.On the other hand, a concentration just sufficient for a therapeutic effect at mammary level is often obtained, by the oral or injectable route, only at the cost of excessive activity at uterus level, sometimes causing an atrophy of the tunica mucosa uteri, or even a metrorhagia. The percutaneous route therefore enables the disparity of the respective concentrations to be reversed and the desired effect on the mammary gland to be obtained, without undesirable repercussions on the uterus.
According to the invention, the progesterone is therefore applied by the percutaneous route in the form of a dilute alcoholic gel having a concentration of 1%. In other words, for 100 grams of composition, the progesterone is present at the rate of 1 gram and the excipient is constituted by a carboxypolyvinyl polymer, triethanolamine, 95" alcohol and purified water. The progesterone, at breast level, opposed the increase in the capillary permeability provoked by the oestrogens, it participates in the growth and differentiation of the galactophori and acini and it blocks the cycle of the rapid epithelial mitoses provoked by the oestrogens.
The administration of pure progesterone by the percutaneous route makes it possible to treat and prevent the vascular and cellular effects of a local deficit of progesterone at breast level. It may be employed in all cases of benign mammary pathology, such as mastodynias, mastopathias, prevention of recurrences (cysts, adeno-fibromas). Therapeutical tests have been made on a group of 52 women, in two ways namely:
In a first group, only the progesterone was administered by the percutaneous route in 26 patients whilst, in the second group of 26 patients, the progesterone was administered by the percutaneous route in association with a synthetic luteomimetic, an oestroprogestative or other hormonal medication.
In each of the two groups of 26 paitents, the following had been observed: essential mastodynias, i.e. painful phenoma of congestion without any morphological substratum on physical examination (four times in group 1, six times in group 2); a mastopathia in the form of an isolated cystic dystrophy or of multiple microcysts without mastodynias (five times in group 1,fourtimes in group 2); a mammary dystrophy associated with a mastodynia (thirteen times in group 1, eight times in group 2); the existance of organised benign mammaryforma- tions associated or not with a mastodynia and/or with a cystic dystrophy (four times in group 1, eigth times in group 2).
In the 52 patients referred to above, the progesterone was administrated by the percutaneous route in the form of dilute alcoholic gel at a concentration of 1%. A dose of 5 grams was applied to the two breasts each day, from the beginning ofthe cycle and during menstruation for one month, then in the second part of the cycle during the following two months.
In group 1, the results were excellent in eight cases and good in seven cases. The results were considered as being excellent when an improvement or disappearance of the mastodynia, a regression of the mammary swelling with disappearance of the local phenomena of cutaneous hypervascularisation and, when associated with a mastopathia, an involution of the latter, were observed in the patients. The results were considered good when the mastodynia disappeared and the mastosic element persisted, and mediocre when there was persistence of the disorders, although they were attenuated. In group 1, only seven mediocre cases and three failures were obtained.
With the patients of group 2, the results varied depending on the therapeutic association of the percutaneous progesterone and, the luteomimetics of synthetic oestroprogestatives by the oral route. In virtually all types of association, a majority of cases with excellent or good results was always encountered. General tolerance was excellent in all cases.
No repercussions of the percutaneous therapy by progesterone was observed on the menstrual cycle, nor on the digestive, particularly hepatic, function, nor did the patients put on weight, as may be the case when luteomimetics or oestroprogestatives are taken orally. No local cutaneous intolerance was observed during application, nor allergic phenomenon nor cutaneous pigmentation.
1. Medicament based on progesterone for the treatment of mamxary disorders such as mastodynias and mastopathias, wherein it is presented in the form of gel for application by the percutaneous route.
2. The medicament of claim 1, wherein it is constituted by a dilute alcoholic gel.
3. The medicament of claim 2, wherein it comprises 1% of pure progesterone.
4. The medicament of claim 3, wherein the excipient is constituted by a carboxypolyvinyl polymer, triethanolamine, 95% alcohol and purified
**WARNING** end of DESC field may overlap start of CLMS **.
Claims (5)
1. Medicament based on progesterone for the treatment of mamxary disorders such as mastodynias and mastopathias, wherein it is presented in the form of gel for application by the percutaneous route.
2. The medicament of claim 1, wherein it is constituted by a dilute alcoholic gel.
3. The medicament of claim 2, wherein it comprises 1% of pure progesterone.
4. The medicament of claim 3, wherein the excipient is constituted by a carboxypolyvinyl polymer, triethanolamine, 95% alcohol and purified water.
5. Medicament substantially as hereinbefore described.
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR8120034A FR2515041A1 (en) | 1981-10-26 | 1981-10-26 | PROGESTERONE-BASED DRUG FOR THE TREATMENT OF MAMMARY DISEASES |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| GB2109231A true GB2109231A (en) | 1983-06-02 |
Family
ID=9263374
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| GB08229804A Withdrawn GB2109231A (en) | 1981-10-26 | 1982-10-19 | Medicament containing progesterone |
Country Status (3)
| Country | Link |
|---|---|
| DE (1) | DE3238984A1 (en) |
| FR (1) | FR2515041A1 (en) |
| GB (1) | GB2109231A (en) |
Cited By (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0667826B2 (en) | 1984-01-20 | 1994-08-31 | モベ−ジヤ−ビス，ピエ−ル | Anti-estrogen drug for transdermal administration |
| US6503894B1 (en) | 2000-08-30 | 2003-01-07 | Unimed Pharmaceuticals, Inc. | Pharmaceutical composition and method for treating hypogonadism |
| US6670350B1 (en) * | 1999-02-18 | 2003-12-30 | Jenapharm Gmbh & Co. Kg | Method of administering dienogest in high dosages to reduce the body of the breast and pharmaceutical composition for same |
| US6696433B2 (en) | 1996-07-22 | 2004-02-24 | Renovo Limited | Use of sex steroids function modulators to treat wounds and fibrotic disorders |
| DE102008064534A1 (en) * | 2008-12-29 | 2010-07-15 | Reimers, Simon | External frame for connection with two-wheeled electric car, for perpendicular locomotion of paralyzed/handicapped persons, has bar provided in hip height on driving body, where passenger body is fixed in frame and connected with car |
| US8466138B2 (en) | 2005-10-12 | 2013-06-18 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
Families Citing this family (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5744463A (en) * | 1996-06-03 | 1998-04-28 | Bair; Glenn O. | Treatment of side effects of progestins and progesterone analogues used for birth control |
| US6056972A (en) * | 1997-02-26 | 2000-05-02 | Dimera, Llc | Method for reducing coronary artery reactivity |
| US7968532B2 (en) | 2003-12-15 | 2011-06-28 | Besins Healthcare Luxembourg | Treatment of gynecomastia with 4-hydroxy tamoxifen |
| US7507769B2 (en) | 2004-03-22 | 2009-03-24 | Laboratoires Besins International | Treatment and prevention of benign breast disease with 4-hydroxy tamoxifen |
| CA2559748C (en) * | 2004-03-22 | 2013-05-28 | Elisabeth Le Nestour | Treatment and prevention of benign breast disease with 4-hydroxy tamoxifen |
| EP1579856A1 (en) * | 2004-03-22 | 2005-09-28 | Laboratoires Besins International | Treatment and prevention of benign breast disease with 4-hydroxy tamoxifen |
Family Cites Families (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| GB1047518A (en) * | 1963-06-11 | 1966-11-02 | Glaxo Lab Ltd | 17ª-monoesters of 11,17,21-trihydroxy steroid compounds |
| US4136173A (en) * | 1977-01-31 | 1979-01-23 | American Home Products Corp. | Mixed xanthan gum and locust beam gum therapeutic compositions |
| DE2964471D1 (en) * | 1979-06-08 | 1983-02-17 | Toko Yakuhin Kogyo Kk | Creamy preparation containing steroid and process for the preparation thereof |
-
1981
- 1981-10-26 FR FR8120034A patent/FR2515041A1/en active Granted
-
1982
- 1982-10-19 GB GB08229804A patent/GB2109231A/en not_active Withdrawn
- 1982-10-21 DE DE19823238984 patent/DE3238984A1/en active Granted
Cited By (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH0667826B2 (en) | 1984-01-20 | 1994-08-31 | モベ−ジヤ−ビス，ピエ−ル | Anti-estrogen drug for transdermal administration |
| US6696433B2 (en) | 1996-07-22 | 2004-02-24 | Renovo Limited | Use of sex steroids function modulators to treat wounds and fibrotic disorders |
| US6670350B1 (en) * | 1999-02-18 | 2003-12-30 | Jenapharm Gmbh & Co. Kg | Method of administering dienogest in high dosages to reduce the body of the breast and pharmaceutical composition for same |
| US6503894B1 (en) | 2000-08-30 | 2003-01-07 | Unimed Pharmaceuticals, Inc. | Pharmaceutical composition and method for treating hypogonadism |
| US9132089B2 (en) | 2000-08-30 | 2015-09-15 | Besins Healthcare Inc. | Pharmaceutical composition and method for treating hypogonadism |
| US9125816B2 (en) | 2000-08-30 | 2015-09-08 | Besins Healthcare Inc. | Pharmaceutical composition and method for treating hypogonadism |
| US8466137B2 (en) | 2005-10-12 | 2013-06-18 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
| US8466136B2 (en) | 2005-10-12 | 2013-06-18 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
| US8486925B2 (en) | 2005-10-12 | 2013-07-16 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
| US8729057B2 (en) | 2005-10-12 | 2014-05-20 | Unimed Pharmaeuticals, LLC | Testosterone gel and method of use |
| US8741881B2 (en) | 2005-10-12 | 2014-06-03 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
| US8754070B2 (en) | 2005-10-12 | 2014-06-17 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
| US8759329B2 (en) | 2005-10-12 | 2014-06-24 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
| US8466138B2 (en) | 2005-10-12 | 2013-06-18 | Unimed Pharmaceuticals, Llc | Testosterone gel and method of use |
| DE102008064534A1 (en) * | 2008-12-29 | 2010-07-15 | Reimers, Simon | External frame for connection with two-wheeled electric car, for perpendicular locomotion of paralyzed/handicapped persons, has bar provided in hip height on driving body, where passenger body is fixed in frame and connected with car |
Also Published As
| Publication number | Publication date |
|---|---|
| FR2515041B3 (en) | 1984-06-15 |
| DE3238984C2 (en) | 1991-12-19 |
| DE3238984A1 (en) | 1983-05-05 |
| FR2515041A1 (en) | 1983-04-29 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| WAP | Application withdrawn, taken to be withdrawn or refused ** after publication under section 16(1) |