FR2515041A1 - PROGESTERONE-BASED DRUG FOR THE TREATMENT OF MAMMARY DISEASES - Google Patents

Abstract

THE PRESENT INVENTION RELATES TO A PROGESTERONE-BASED MEDICINAL PRODUCT FOR THE TREATMENT OF BREAST AFECTIONS SUCH AS MASTODYNIA AND MASTOPATHIES. THIS MEDICINAL PRODUCT IS CHARACTERIZED IN THAT PROGESTERONE IS IN THE FORM OF A GEL APPLIED BY PERCUTANEOUS ROUTE.

Description

The present invention relates to a medicament

  progesterone-based treatment for the treatment of

  mammary such as mastodynies and mastopathies.

  This drug is characterized in that the

  gestérone is in the form of peristually applied gel. It has indeed been discovered, according to the invention that

  progesterone has, among the hormonal steroids, the

  In fact, when a progesterone solution is administered percutaneously, 80% of the steroids are metabolized in the skin and only 20% are metabolized in the skin.

  likely to pass the cutaneous barrier.

  progesterone provides, in breast disease, an advantage

  because it allows the administration and concentration of

  In contrast, a concentration that is just sufficient for a therapeutic effect at the breast level is often not obtained by the breast receptor of a large quantity of progesterone.

  oral or injectable, at the cost of excessive activity

  uterine calf sometimes leading to atrophy of the endometrium, or even metrorrhagia. The percutaneous route therefore reverses the

  disparity in the respective concentrations and to obtain the desired effect

  on the mammary gland, without undesirable uterine resonance.

  According to the invention, the progesterone is therefore applied percutaneously in the form of a hydroalcoholic gel having a concentration of 1%. In other words, per 100 grams of composition, progesterone is present at a rate of 1 gram and the excipient consists of a carboxypolyvinyl polymer, the

  triethanolamine, 95% alcohol and purified water.

  terone, at the level of the breast, opposes the increase in permeability

  capillary action caused by estrogens, it participates in the growth and differentiation of galactophores and acini and blocks the cycle of rapidly induced epithelial mitosis

by estrogens.

  Administration of pure percutaneous progesterone can treat and prevent vascular effects

  and cellular local deficiency of progesterone in the breast.

15041

  It can be used in all cases of breast pathology

  such as mastodynies, mastopathies, prevention of recurrence

  dives (cysts, adeno-fibroids) Therapeutic trials were carried out on a group of 52 women, in two ways. In the first group, only 26 patients were given progesterone percutaneously.

  that in the second group of 26 patients, the progres-

  percutaneous terona in combination with a synthetic luteomimetic,

  estrogen / progesterone or other hormonal medication.

  In each of the two groups of 26 patients,

  there were essential mastodynies, that is, phenomena

  painful congenital leads without any morphological substratum on physical examination (four times in group 1, six times in group 2); mastopathy in the form of isolated cystic dystrophy or multiple microcysts without mastodynia (five times in group 1, four times in group 2); mammary dystrophy associated with mastodynia (thirteen times in group 1, eight times in group 2); the existence of organized benign mammary formations with or without mastodynia and / or dystrophy

  cystic (four times in group 1, eight times in group 2).

  In the 52 patients mentioned above, progesterone

  was administered percutaneously as a hydroalcoholic gel.

  at a concentration of 1% A dose of 5 grams was spread on both breasts each day, from the beginning of the cycle and during the menstrual period for one month, then in the second part of the cycle in the

two months later.

  In group 1, the results were excellent

  slow in eight cases and good in seven cases The results were considered to be excellent when there was improvement or discontinuation of mastodynia in the patients, regression of breast swelling with disappearance of

  dermal hypervascularization and when a muscle was

  topathy, an involution of it The results have been

  considered as good when the mastodynia disappears and the

  remains persistent, and mediocre when there is persistence of the disorders, although these are reduced In group 1,

  got only seven mediocre cases and three failures.

  With patients in group 2, the results were variable depending on the therapeutic combination of percutaneous progesterone and luteomimetic oral or estroprogestative synthesis In almost all types of association, we have always encountered a majority of cases with excellent or good results Overall tolerance was excellent in all cases There was no evidence of

  percutaneous therapy with progesterone on the menstrual cycle.

  truel, nor on the digestive function in particular hepatic nor weight gain as we can meet when taking oral luteomimetics or estroprogestatifs We did not find no

  more local cutaneous intolerance during application, nor any

  does not allergen or cutaneous pigmation.

Claims (3)

  1 Progesterone-based medicinal product for the treatment of   such as mastodynies and mastopathies, which are   it is present in the form of percutaneously applied gel. Medicinal product according to claim 1, characterized in that   consists of a hydro-alcoholic gel.   Medicament according to claim 2, characterized in that includes 1% pure progesterone.   Medicinal product according to Claim 3, characterized in that the excipient consists of a carboxypolyvinyl polymer,   triethalonamine, 95 alcohol and purified water.