Use of Magnesium Phosphate for the Treatment of Vaginal Atrophy

Description

“Use of magnesium phosphate for the treatment of vaginal atrophy” DESCRIPTION Technical Sector The present invention relates to the therapeutic use of magnesium phosphate in 5 treatment of vaginal atrophy, particularly, but not exclusively, associated with vaginal dryness. Art Note A woman's body undergoes many changes over time, from puberty to the twenties. fertile, post-menopausal. The level of hormones in the body fluctuates during these periods and the 10 production of estrogen, testosterone, and progesterone changes. Women may experience symptoms such as: irregular menstrual cycles, hot flashes, insomnia, night sweats, sleep irregularities, confusion, moodiness, fatigue, mood swings, vaginal dryness, vaginal pain, urinary urgency, discomfort during sexual intercourse, breast tenderness, low sex drive, and loss of bone density. 15 A common problem that occurs during periods of hormonal fluctuation is the dryness of tissues. This dryness can occur in the epithelial tissue of any part of the body, although it is a particularly relevant problem in delicate and sensitive tissues such as the breasts, vulva, vagina, lips and face. The vulvar skin has an ectodermal origin from the urogenital sinus. The squamous epithelium 20 multilayered cervico-vaginal instead is of Müllerian origin and is found to be highly estrogen sensitive. This mucosa changes during the various stages of life life and during fertile life it is subject to the cyclical hormonal action of ovarian activity. Estrogen is responsible for the increase in thickness, while progesterone blocks proliferation in the middle layer of the mucosa. 25 As we age, the vagina becomes shorter, roughness disappears, elasticity decreases. leaks and vaginal discharge becomes scanty The reduction of the barrier function due to vaginal secretion makes the skin vaginal more subject to chemical and mechanical damage. The close proximity to the rectum, moreover, increases the possibility of microbial colonization by invading germs of species origin 30 intestinal, such as Escherichia coli or Enterococcus faecalis. The vaginal ecosystem is the set of microorganisms that populate the parts of the body in contact with the external environment (skin and mucous membranes) among which the most important are lactobacilli of Doderlein, which produce lactic acid and hydrogen peroxide, which contribute to maintain a low vaginal pH (around 4). Various hormones are also actively produced antimicrobial molecules, such as beta defensins and cathelicidins, which intervene directly in the cell-mediated immune response, and bacteriocins and lactobiocins, which they are real biological "ammunition" that defend the vagina in association with the lower pH, these peptides play a key role in preventing colonization by microbes 5 pathogens. With impaired barrier function, cell-mediated immunity acquires a more important role in the prevention of symptomatic infections: the vulvar skin contains a higher concentration of antigen-presenting cells (antigen cells) Langerhans) compared to other sites in the body. 10 Unfortunately, cell-mediated immunity also declines functional with aging: Langerhans cells reduce by about 50%, the pH increases, the production of antimicrobial peptides decreases, facilitating infections. Vaginal or vulvar dryness clinically causes burning and itching. At the microscopically there is an alteration of the skin lipids and a loss of water from the layer 15 superficial (about 25% of the normal content). The consequence is the impairment of the barrier function of the skin, the greater permeability towards microorganisms and chemicals present in the environment, the lower mechanical resistance and the increase in reactivity to external agents. Although hormonal changes occur throughout life, women 20 experience the greatest ones during perimenopause and menopause. Perimenopause is the period of time before a woman reaches menopause during the which the female body undergoes a transition in the production of hormones and other biological functions related to fertility loss. While for most women Perimenopause begins around the age of forty, for some it can begin as early as the end of the 25 thirty years. The average age for reaching menopause is around fifty-two years but, in In some cases, perimenopause can last even more than ten years. While vaginal atrophy refers mainly to the problem typical of women of advanced age due to menopause, vaginal dryness is a problem that affects even women of childbearing age, so much so that it is estimated that around 15% may suffer from it. 30 Vaginal dryness occurs early in the postmenopausal period and It is mostly reported by sexually active women and may be associated with pain and dyspareunia during sexual intercourse. Vaginal dryness is a very common disorder that can affect women of any age, particularly in menopause, due to the reduction in estrogen levels which cause the onset of vaginal atrophy, or a reduction in the thickness of the mucosa vaginal associated with inflammation. Vaginal atrophy is also included in the broader genitourinary syndrome, in which causes thinning of the vaginal mucosa with the possible appearance of petechiae, 5 may be associated with urethral burning, urinary frequency and urgency, hematuria, or the presence of traces of blood in the urine, dysuria, that is, painful urination, the sensation lower abdominal weight and the presence of recurrent genitourinary tract infections. Approximately 40% of postmenopausal women experience vaginal atrophy or dryness vaginal. 10 During vaginal atrophy, the vaginal epithelium decreases in thickness, hydration, wrinkles (folds) and blood flow. Causes of atrophic vaginitis include a decrease in the amount of estrogen present both locally and systemically, as well as environmental factors such as chemotherapy, antihistamines, cigarette smoking, exercise excessive and perineal products (e.g. douches, deodorants and perfumes). 15 This vaginal atrophy can be mild, moderate or severe. At its basis are the hormonal changes associated with the menstrual cycle, to aging, menopause, pregnancy and breastfeeding, which can influence the hydration of the vaginal walls. Vaginal dryness, however, can occur at any age, but appears 20 especially in women exposed to situations of reduced estrogen production. Vaginal dryness due to lack of natural lubrication of the vagina has multiple causes, it can be triggered not only by menopause (due to the exhaustion of the activity of the ovaries), in women of childbearing age also by emotional factors such as stress, by factors physiological-hormonal such as pregnancy, in the puerperium (due to hormonal changes 25 transitory ones that follow childbirth), breastfeeding (prolactin, a hormone that stimulates the milk production, "puts the ovaries to rest"), conditions of relative hypoestrogenism and from vascular disorders associated with systemic diseases such as heart disease and diabetes or from habits like smoke. Furthermore, it can be induced by chemotherapy or radiological treatments following 30 oncological pathologies. It can also occur following autoimmune pathologies such as, for example for example, Sjögren's syndrome which also causes dry eyes and mouth. Mild vaginal dryness may occur after treatment contraceptive (the pill “puts the ovaries to rest”) or for vulvovaginitis such as candidiasis. Both vaginal atrophy and dryness cause pain and discomfort, burning and vaginal discharge; genital itching; burning or urgency related to urination; discomfort during and slight bleeding after sexual intercourse; reduced lubrication vaginal during sexual activity; shortening and stiffening of the vaginal canal; 5 pelvic floor muscle convulsions; and atrophic vaginal closure included scarring and organ prolapse through the vagina. The vagina in fact has a common embryogenetic derivation with the urethra and bladder and this can lead over time to the appearance of common dystrophic alterations, the natural Lubrication is maintained by estrogen, the female sex hormone. When levels of 10 Estrogen decreases during menopause, estrogen-dependent tissue will begin an involution and to take on the characteristic appearance of estrogen deprivation. Cervical mucus levels decrease and vaginal mucosa regresses during menopause. Most of the vaginal fluid of postmenopausal women appears to be be the result of the secretion of the vaginal epithelium. 15 To alleviate some of the symptoms caused by hormonal fluctuations, they are often hormone treatments, such as patches containing slow-release hormones, are administered. It is known in the literature that, while hormone replacement therapy can reduce some symptoms, such as hot flashes, sweating and mood changes, is less effective in treating symptoms associated with vaginal and vulvar atrophy and dryness. 20 Hormone therapy involves the administration of hormonal drugs in targeted formulations and dosages that promote and increase blood flow in the vagina promoting the supply of nutrients and oxygen to the tissues, but has the disadvantage of having as a contraindication thrombotic risks which may include an increased risk of peripheral venous thrombosis and, in subjects at risk, pulmonary embolism. 25 The therapies are very different and vary according to the degree of atrophy. There are non-hormonal treatments such as, for example, the use of hyaluronic acid available in gel form or ovules which are used as an adjuvant in atrophic and dystrophic conditions and in dryness senile caused by estrogen deficiency, or low-dose local hormone treatments like Estriol gel which however should only be prescribed after a careful anamnesis of the patient 30 to exclude any contraindications. In case of moderate or severe atrophic pathology, the use may be indicated of Prasterone vaginal ovules, which allows to obtain benefits for the entire genitourinary district urinary. Also in this case, of course, the treatment must be prescribed after a careful evaluation of the individual clinical picture. Another drug indicated in cases of atrophy moderate or severe is Ospemifene which is part of the SERM family, or modulators selective estrogen, which acts like estrogen on some tissues such as the mucosa vaginal. When estrogen is administered, some of these effects are reversed: 5 the cervix may secrete more mucus and the vaginal mucosa may regain lost layers. However, symptoms often do not disappear completely, partly because the amount of estrogen provided for hormone replacement is lower than circulating estrogen levels during a normal menstrual cycle. Because the vagina in menopause loses collagen and the ability to retain water, 10 hyaluronic acid is used as an adjuvant in the repair processes of atrophic states and dystrophic lesions of the vaginal mucosa and in senile vaginal dryness due to deficiency estrogenic. Estrogen or hormone replacement therapy (HRT) are effective in reducing vaginal dryness. However, possible dangerous side effects include increased 15 incidence of breast cancer, endometrial cancer, blood clots, nausea, tension breast pain and headache. In other cases, laser treatments or radiofrequency treatments are performed for improve electroporation. The stimulating action of the laser and / or radiofrequency stimulates the regeneration of the 20 vaginal tissues with a “photo-eutrophic” mechanism where the tissue fibroblasts vaginal are stimulated thanks to the thermal effect of the laser on the vaginal wall to produce a greater quantity of collagen, a protein that gives elasticity and tone to tissues vaginal, and to improve blood circulation in the vagina The repair process triggered therefore promotes tissue regeneration and, 25 consequently, it can lead to an improvement in clinical symptoms. The improvement is gradual and generally requires several sessions over a period of three months consecutive. Laser treatment has limited effectiveness for up to approximately 12-18 months. The action of radiofrequency instead promotes the regeneration of deep tissues of the vagina and vulva, and the local absorption of bioactive substances or hyaluronic acid. 30 These treatments are however very expensive and very often are not well tolerated by the patients, in addition to the fact that they need to be repeated periodically to maintain the results. In light of the above, there is a strong need for solutions new and / or alternative therapies that alleviate the symptoms associated with these pathologies and / or treat the pathologies themselves. There is therefore a need to have new effective pharmaceutical compositions in the treatment of vaginal atrophy and dryness and are preferably free of hormones. It is also important that the compositions are well accepted by the patients, in a 5 pharmaceutical form that allows easy application and limited administration in so as not to affect the normal performance of daily activities. Furthermore, it is It is necessary that the administration of such compositions does not have side effects. Schüssler salts (or tissue salts) are also known in literature, preparations based on diluted mineral salts, invented in the second half of the nineteenth century by the German doctor Wilhelm 10 Schüssler. Schüssler salts are natural products derived from diluted inorganic salts homeopathically. These are chemically pure, physiologically and chemically closely related to the cells of the human body. Simple to use, They are a valuable support, with a broad spectrum of action and can be taken together with 15 other drugs. Dr. Schüssler's experiments led him to select twelve salts minerals. Schüssler Salts are used to relieve, prevent and assist in the treatment of various disorders. Among these are: 20 • Dysfunctions of the skeletal system: such as bone fragility, contractures, pathologies of the spine, various neuralgias including sciatica, or rheumatic affections of the joints and fractures. • Nervous system dysfunctions, such as spasms and convulsions, nervous palpitations. • Respiratory problems such as catarrh, asthma, whooping cough, bronchitis, sinusitis 25 or cold. • Tissue changes, such as various types of inflammation (caries, varicose veins, hemorrhoids, fistulas, wounds, hematomas, etc.). • Hardening of organs, liver hypertrophy, gravel, gout. • To restore skin balance, in cases of edema, dermatitis, blisters, warts. 30 • They help the digestive system (even in children), intervening in case of regurgitation, belching, acid vomiting, flatulence, diarrhea. • Also useful in cases of vaginal discharge, cystitis, thyroid dysfunction and in pregnancy. Schüssler's biochemical therapy is based on twelve inorganic mineral remedies, related to those present in cellular tissues, prepared in the form of homeopathic dilution (Hanemannian decimal). Each salt corresponds to problems caused by the deficiency. of the same. 5 These twelve mineral salts are crushed powders that have been subjected to homeopathic dynamization and have the property of catalyzing certain reactions biochemical. They are usually used at the sixth dilution (D6), which has the advantage of producing a rapid and intense acceleration of the defensive, purifying and metabolic processes. 10 Salt number 7, Magnesium phosphoricum (magnesium phosphate) is also called the Salt for cramps and pain. This remedy is used primarily to combat spasms. muscle and frequent cramps and is also used in cases of colic, insomnia and agitation. As the name suggests, the main active ingredient in magnesium phosphoric acid (D6) it is magnesium phosphoric acid, a mineral salt found in nature in many substances, including water 15 and the tissues of the human body. The tissues and organs mainly affected are bone and muscle tissue and the nervous system. Magnesium regulates over 300 biochemical processes in our body and is essential for the functioning of numerous enzymes and for biochemical reactions ATP 20 dependent, such as those of the Krebs cycle, is located 60% in the bones, 39% in the in muscles and 1% in blood and other tissues; the maximum amount detectable in humans It is about 25 grams. Our cells have a great greed for this element and continuously try to accumulate it, the need for Magnesium varies according to age and of the individual's health conditions, with a quantity ranging from 300 to 500 mg per day 25 days (the maximum amount allowed in a food supplement is 375 mg per day) day). Given the importance of this mineral, it is normal that a reduction in its levels in the Our body generates symptoms of magnesium deficiency when the plasma concentration is less than 1.9 mg / dl which manifests itself with various symptoms, the most 30 known are: asthenia, muscle cramps and tremors, insomnia, irritability, nervousness and Confusion. In cases of severe hypomagnesemia, cardiac arrhythmias may also be observed. and high blood pressure. It is also important to remember that a magnesium deficiency can cause also from bad eating habits such as the consumption of excessive quantities of flour refined foods that are poor in this mineral, excessive consumption of alcohol and coffee which lead to a reduction in Magnesium, furthermore a diet rich in dairy products which they are rich in calcium but poor in magnesium which translates into a negative balance for the Magnesium. Magnesium is a mineral essential for maintaining good health. 5 health, which is normally introduced into the human body with food, i Foods that are rich in it are green leafy vegetables, such as spinach, artichokes, cereals whole grains such as rice and bran, soy, dried fruit, legumes, bananas, cocoa. The alternative to nutrition to make up for magnesium deficiency is its integration with food supplements, there are different types in different combinations 10 chemicals that influence its absorption. This mineral is found abundantly in the skeleton, muscles, nerves, Brain. It lowers metabolism and blood cholesterol levels. It has anti-allergic effects. and intervenes in the enzymatic processes of neuromuscular and cardiac excitability. The use of Magnesium is known from patent document DE202008000655U1 15 phosphoricum salt of Schüssler No.7 as an effective therapeutic agent for the treatment of disorders, dysfunctions and / or diseases of the muscles and / or joints. According to the teachings of the patent document DE202008000656U1 the use of the Schüssler's Magnesium phosphoricum salt N.7 is suitable for the treatment of acute dysfunctions of the nervous system, restlessness, sleep disorders, migraines and nervousness, with 20 a remarkably rapid recovery. A first problem that the invention aims to solve is how to reduce symptoms associated with vaginal dryness and atrophy. An aim of the present invention is therefore to identify a solution to the aforementioned problem that is simple, rational and low-cost. 25 Another problem that the invention aims to solve is that of treating these pathologies in ways that do not cause unwanted side effects on patients. Another problem that the invention aims to solve is that of having of a composition that can be administered without contraindications to subjects multipathological patients who use other types of drugs at the same time. 30 A further object of the invention is to provide a composition for the treatment of vaginal dryness that has no animal origin due to the difficulty of use them in humans. Another aim of the invention is to re-establish and avoid alterations to the pH optimal vaginal, in order to prevent bacterial infections inside the vagina. Not least aim of the invention is to provide a composition for the treatment for vaginal dryness and atrophy that is available at affordable prices. These and other objects are achieved according to the invention, as claimed in the annexed claims. 5 The present invention is set forth and characterized in the independent claims, while dependent claims set forth other preferred and non-essential features of the present invention, or variants of the main solution idea. Description of the Invention The Applicant has advantageously found the solution to the above requirement 10 reported the administration, or use, of magnesium phosphate or a composition including magnesium phosphate in therapeutic treatment and / or prevention of vaginal atrophy. According to the invention, the use of magnesium phosphate or a composition including magnesium phosphate in therapeutic treatment and / or prevention 15 of vaginal atrophy occurs preferably when vaginal atrophy is associated with vaginal dryness. According to the invention, mainly, the use of magnesium phosphate or a composition comprising magnesium phosphate in the therapeutic treatment and / or in Prevention of vaginal atrophy occurs when the atrophy results from an alteration of the pH 20 outside the range between pH 3.5 and pH 4.5. According to the invention, mainly, the use of magnesium phosphate or a composition comprising magnesium phosphate in the therapeutic treatment and / or in Prevention of vaginal atrophy occurs when vaginal atrophy is caused by an alteration of the skin lipids and a loss of water from the superficial skin layer 25 about 25% of the normal content. According to the invention, mainly, the use of magnesium phosphate or a composition comprising magnesium phosphate in the therapeutic treatment and / or in Prevention of vaginal atrophy occurs when vaginal atrophy is associated with dryness vaginal due to the lack of natural lubrication of the vagina and is caused by: 30 menopause, stress, pregnancy, puerperium, breastfeeding, hypoestrogenism, disorders vascular, heart disease, diabetes, chemotherapy, radiological treatments, pathologies autoimmune diseases such as Sjögren's syndrome, contraceptive treatments, vulvovaginitis, candidiasis. Preferably, according to the invention, magnesium phosphate or a composition containing magnesium phosphate for use in therapeutic treatment and / or prevention of vaginal atrophy are administered in the form of a pharmaceutical composition, together with one or more pharmacologically acceptable excipients. 5 Preferably, according to the invention, magnesium phosphate or a composition containing magnesium phosphate for use in therapeutic treatment and / or prevention vaginal atrophy are administered orally. Still according to the invention, the pharmaceutical composition containing phosphate of magnesium for use in the therapeutic treatment and / or prevention of vaginal atrophy 10 contains a pharmacologically effective percentage of magnesium phosphate and at least one excipient, or a pharmacologically acceptable carrier or diluent. Preferably, furthermore, said pharmaceutical composition for use in the treatment therapeutic and / or in the prevention of vaginal atrophy contains magnesium phosphate in the form of the seventh of the Schüssler salts. 15 Even more preferably said pharmaceutical composition for use in the treatment therapeutic and / or in the prevention of vaginal atrophy contains a quantity pharmacologically effective of Magnesium phosphoricum D6 Salt Dr. Schüssler N.7. The applicant has identified a new therapeutic use of magnesium phosphate and Schüssler's Magnesium phosphoricum salt N.7 for the treatment of vaginal dryness and 20 of vaginal atrophy, therefore effective in treating the symptoms and disorders of these pathologies. Advantageously, the remedy according to the invention is effective regardless of the causes that have provoked these phenomena, favoring a rapid re-epithelialization of vaginal tissues. The applicant faced the problem of finding an effective remedy to treat the 25 Vaginal dryness and vaginal atrophy typical of women aged between 30 and 66 years. In fact, nowadays there is an ever-increasing interest in the use of natural products. for the treatment of vaginal dryness, but products of animal origin due to the difficulty of using them in humans. 30 The applicant surprisingly found that a compound comprising Schüssler's Magnesium phosphoricum salt N.7 is effective in preventing and / or treating vaginal dryness and vaginal atrophy, especially vaginal dryness typical of women who have reached perimenopause and menopause, caused by amenorrhea persistent physiological condition in women who no longer have ovarian activity. A commercial example of such a compound in homeopathic formulation is marketed by Schwabe Pharma Italia under the name “Magnesium phosphoricum D6 - Dr. Schussler No. 7” As regards the use of Schüssler salts, the present invention - without 5 wanting to limit oneself to this theory - it is based on the principle that diseases or malfunctions of the body can occur on the basis of disturbed biochemical processes (lack of estrogens), which are largely related to a disturbed mineral balance or equilibrium electrolyte, so the lack of a certain mineral can affect the entire metabolism. 10 Taking Schüssler N7 Magnesium Phosporicum salt restores the cellular imbalance of inorganic salts of the lining and skin tissues, including the tissues of the female urogenital system, promoting the correct cellular function of the aforementioned tissues and consequently healing. This rebalancing of inorganic salts inside the cells promotes the 15 renewal of the epithelial structure of the vaginal tissues by restoring the quantity of neurotransmitters that innervate the vaginal tissues and restoring the mineral balance of the cells of the above mentioned tissues. In this way the functional connection between the nerve cells of the vaginal tissues and consequently the normal functionality of the tissues vaginal ones themselves, with consequent treatment of the above-mentioned vaginal pathologies and of the disorders 20 they are linked. After treatment with the compound of the following invention the hydration of the vaginal walls has returned to normal levels. The intake of the composition in homeopathic concentration can take place essentially by any means. According to the invention, oral administration of the compound is preferable, 25 The compound object of the invention is therefore preferably in the form of tablets, capsules, tablets, granular powder, capsules, orodispersible granules, sachets, sweets or drinkable vials. It is also preferred to administer the compound of the invention as a liquid, for for example as a syrup or as a drink, or it is added to a food, for example to 30 a yogurt, a cheese, a fruit juice. The intake of the homeopathic product is also variable, preferably the intake is done at least 1-2 times a day. The oral formulation of the compound which is the subject of the present invention comprises further generally accepted excipients for the production of homeopathic products and / or pharmaceuticals. Preferably the compound according to the invention contains lactose as an excipient. 5 main ingredient of wheat flour and starch for the preparation of tablets. According to the invention the compound comprises anti-caking agents, preferably magnesium stearate. Furthermore, the Applicant found that this compound is also effective in the treatment of 10 vaginal dryness and atrophy in women with non-persistent amenorrhea due to pregnancy, breastfeeding, puerperium, frequent use of drugs, who have been subjected to surgical interventions and / or chemotherapy and radiotherapy treatments. A second object of the present paper concerns the use of the homeopathic compound in treatment of symptoms and / or for the cure of vaginal dryness and atrophy in women 15 young women of childbearing age presenting with non-persistent amenorrhea of ​​various origins. The compound and its use in accordance with the second object of the invention are as follows: described in the first object of the invention. A third object of the present invention is the use of the compound in the treatment and prevention of vaginitis and vaginosis typical of women between 30 and 65 years of age. 20 Vaginitis refers to all inflammations that affect the walls of the vagina, of the vulva called vulvovaginitis, of the cervix called cervicovaginitis and less often of the urethra. In accordance with the first and second objects of the invention and their use, the renewal of the epithelial structure of the vaginal tissues thanks to the intake of the 25 compound according to the invention allows the renewal of vaginal tissues and consequence the normal functionality of the vaginal tissues themselves, with consequent pH stabilization between 3.5 and 4.5, restoring the typical vaginal ecosystem moderately acidic in which pathogens, harmful bacteria and yeasts that are responsible for infections of various kinds such as vaginitis and vaginosis. 30 Preferably in accordance with the third object of the invention, the compound is administered once daily. The compound according to the invention was found to be well tolerated and showed no irritation. of the mucous membranes. The compound of the present invention is effective without the administration of hormones for use in the prevention and / or treatment of vaginal atrophy and dryness. The compound according to the invention has no side effects and can be associated possibly to hormonal therapies for the same therapeutic indication. 5 The compound according to the invention has been found to be effective for the treatment of atrophy vaginal. A clinical study performed on women diagnosed with vaginal atrophy is described, made on the basis of the following symptoms: vaginal dryness, itching and / or vulvar irritation, bleeding, vaginal health index (VHI) and a visual analogue scale (VAS - Visual 10 Analogue Scale). VAS is a subjective rating scale in which the perception of a certain sensation by a subject; in the present case Invention vaginal pain associated with sexual activity was measured. Symptoms were assessed through validated questionnaires completed by patients in each symptom is associated with a scale with a minimum and maximum value. The following scales were associated with the symptoms considered in the study: assessment: i) Vaginal dryness: values ​​from 0 to 3 depending on the perception of discomfort provoked, where 0 indicates no discomfort and 3 indicates intense discomfort; ii) Itching and / or vulvar irritation: values ​​from 0 to 3, where 0 indicates no itching and 3 20 indicates intense itching. iii) pH: pH values ​​greater than 5 are indicative of an altered vaginal system; iv) Vaginal pain: measured by VAS with an index from 0 to 10, where 0 indicates no pain and 10 indicates severe pain; v) Vaginal pain associated with sexual activity: measured by VAS with index 25 from 0 to 10, where 0 indicates no pain and 10 indicates severe pain; vi) Burning: values ​​from 0 to 3, where 0 indicates no burning; 3 indicates burning intense; vii) Vaginal Health Index (VHI): This index considers the overall elasticity of the mucosa, secretion, pH, appearance of the epithelial mucosa and hydration of the 30 mucosa. VHI can range from 5 to 25 and lower scores correspond to greater atrophy. urogenital; if the score is less than 15, the vagina is considered atrophic. The present invention may be better understood in light of the following results experimental results of a clinical study on 29 women aged between 30 and 75 years. Patient enrollment criteria were as follows: 1) Women who have been postmenopausal for at least 2 years; 2) Postmenopausal women with vaginal atrophy; 3) Women with at least one of the symptoms of vaginal atrophy. A double-blind clinical study was conducted in which neither patients nor 5 experimenters know which treatment will be given to the patient. 57 3 2.5 5.5 7 7  2 57 3 3 5.8 6 9  3 54 3 2.5 5.9 5 7  4 46 3 2.5 6.0 5 7  5 54 3 2.5 5.8 10 6 Fibromyalgia   6 58 3 3 5.8 6 8  7 59 3 3 6.0 7 7 Chemotherapy   oncology 8 55 3 2 5.9 5 10  9 57 3 3 5,7 7 9  10 62 3 2.5 5.6 6 8  11 50 3 2.5 5.4 8 7   12 46 3 3 6.5 10 6 Candida   13 66 3 3 5.5 7 7  14 35 3 3 5.7 5  7  Postpartum / breastfeeding 15 55 3 2 5.8 7 8  16 53 3 2.5 5.4 5 9  17 50 3 3 5.6 9 7   18 55 3 2.5 5.9 8 8  19 36 3 3 5.0 4 7 Postpartum /  breastfeeding 20 59 3 2 5.2 6 9  Sample Age [30-75 Nuisance [0-3] Itching [0-3] pH Pain [0-10] Burning VHI [5-25] Dryness Atrophy Other patient pathologies 21 54 3 2.5 5.8 7  7  22 39 3 2.5 5.6 8 7 23 35 3 2 5.7 2 9 Postpartum / breastfeeding 24 62 3 3 5,4 6 8  25 58 3 2.5 5.8 5 8  26 40 3 3 5.5 8 7 Chemotherapy   oncology 27 75 3 3 5.5 7 7  28 50 3 2.5 5.4 8 7  29 30 3 3 5.7 5  7  Table 1: Summary of validated patient symptom questionnaires completed by patients before starting the administration of the compound according to the invention. 5 The randomized, double-blind study on 29 women for the treatment of vaginal dryness and vaginal atrophy in which 27 women were given tablets of Magnesium phosphoricum D6 Salt Dr. Schüssler N.7 250 mg per day for a period of 60 days and 2 women were given visually identical placebos including those of Magnesium phosphoricum D6 Salt Dr. Schüssler N.7, but devoid of any principle 10 pharmacological or chemically active and therefore has no therapeutic efficacy, the so-called placebo effect. The administration of the placebo, in a formulation completely identical to that of the experimental drug, allows the blindness of the experimenter and / or the patient to be maintained with respect to the treatment; in turn, blindness prevents voluntary or involuntary conditioning 15 may influence the outcome of the trial, in favor or against the treatment experimental. The compound according to the invention was administered to patients for the prophylactic or therapeutic curative treatment of disorders associated with vaginal dryness and in vaginal atrophy, the compound in combination and in effective quantities, particularly effective 20 from a pharmaceutical or homeopathic point of view. Table 1: Summary of validated patient symptom questionnaires completed by patients before administration of the compound according to the invention. The patient indicated in row 5 of the table suffers from fibromyalgia. All The patients on whom the clinical study was carried out had been suffering from dryness for a long time vaginal and vaginal atrophy and had already undergone various treatments of the known art without obtain a solution to the related problems and disorders. 1 57 1.5 2.5 5.0 4 14  2 57 2 3 5,2 4 15  3 54 2.5 2.5 5.2 2 15  4 46 2.5 2.5 5.4 2 16  5 54 1.5 2.5 5.0 7 14 Fibromyalgia   6 58 2 3 5,2 3 15  7 59 3 3 6.0 7  7  Chemotherapy oncology 8 55 1.4 2 5.3 3 16  9 57 2 3 5,4 4 15  10 62 2 2.5 5.0 2 15  11 50 1.5 2.5 5.3 5 14   12 46 3 3 6.5 7  10  Candida 13 66 2 3 5.0 4 14  14 35 1.5 3 5.4 2  15  Postpartum / breastfeeding 15 55 2 2 5.5 3 14  16 53 2 2.5 5.0 4 9  17 50 3 3 5.6 9 7   18 55 1.5 2.5 5.5 6 14  19 36 2.5 3 4.5 2 15 Postpartum /  breastfeeding 20 59 2 2 4.8 3 16  21 54 2 2.5 5.0 3 14   22 39 1.5 2.5 5.1 5 15 Sample Age [30-75] Nuisance [0-3] Itching [0-3] pH Pain [0-10] Burning VHI [5-25] Dryness Atrophy Other patient pathologies 23 35 2 2 5.0 0 16 Postpartum / breastfeeding 24 62 1.5 3 4.9 4 15  25 58 2 2.5 5.2 2 15  26 40 1.5 3 4.9 5 14 Chemotherapy   oncology 27 75 2 2 5.1 4 15  28 50 2 1.5 5.4 8 7  29 30 2.5 2 5.7 5 7   Table 2: Summary of validated patient symptom questionnaires completed by patients after 14 days of administration of the compound according to the invention. All patients subjected to the study showed improvements after the 5 administration of the compound according to the invention except for the patients indicated in table at rows 7 and 17 for which no improvement from the original situation was noted. For the patient in row 12 suffering from candidiasis, a slight improvement was noted of the symptoms. The use of the compound according to the present invention after 14 days of administration 10 leads to the reduction of at least one of the values ​​associated with this pathology: - the vaginal health index (VHI) increases from a value of approximately 7 before treatment to a value of 15; - vaginal pH decreases from an average value of around 6.0 to an average value of around 5; - itching decreases from intense to medium (scale from 3 to 0); 15 - the burning sensation decreases from intense to medium (scale from 3 to 0); - the VAS for pain associated with sexual intercourse decreases from intense medium to around 5 (scale from 10 to 0). 1 57 1.0 2.5 4.8 4 20  Sample Age [30-75] Nuisance [0-3] Itching [0-3] pH Pain [0-10] Burning VHI [5-25] Dryness Atrophy Other patient pathologies 2 57 2 3 5,2 4 21  3 54 1.5 2.5 5.2 2 20  4 46 1.5 2.5 4.8 2 22  5 54 1.5 2.5 5.0 7 19 Fibromyalgia   6 58 2 3 5,2 3 19  7 59 3 3 6.0 7 7 Chemotherapy   oncology 8 55 1.0 2 4.8 3 21  9 57 1 3 4,9 4 20  10 62 1 2.5 5.0 2 19  11 50 1.5 2.5 5.0 5  20  12 46 3 3 6.5 7 10 Candida   13 66 2 3 4.8 4 20  14 35 1.5 3 5.0 2 20 Postpartum /  breastfeeding 15 55 1 2 5,1 3 19  16 53 1 2.5 4.8 4 17  17 50 3 3 5,6 9  7  18 55 0 2.5 5.2 4 20  19 36 1.5 3 4.5 2 20 Postpartum /  breastfeeding 20 59 1 2 4.8 3 20  21 54 1 2.5 4.9 3 18  22 39 0.5 2.5 4.9 5 19 23 35 1 2 5.0 0 19 Postpartum / breastfeeding 24 62 1 3 5.0 4 20  25 58 1 2.5 5.0 2 20  26 40 1 3 5.5 4 18  Chemotherapy oncology 27 75 1 2 5.0 3 19  28 50 1 1.5 4.6 5 20  29 30 1 1.5 4.8 4 21   Table 3: Summary of validated patient symptom questionnaires completed by patients after 30 days of administration of the compound according to the invention. All patients subjected to the study showed improvements after the administration of the compound according to the invention to patients except those indicated in the table at rows 7 and 17 for which no improvement from the original situation was noted. For the patient in row 12 suffering from candidiasis, a slight improvement was noted 5 of the symptoms. The use of the compound according to the present invention after 14 days of administration leads to the reduction of at least one of the values ​​associated with this pathology: - the vaginal health index (VHI) increases from a value of approximately 7 before treatment to a value of 20; 10 - vaginal pH decreases from an average value of approximately 5.0 to an average value less than 5; - itching decreases from medium to moderate (scale from 3 to 0); - burning sensation decreases from medium to moderate (scale from 3 to 0); - the VAS for pain associated with sexual intercourse decreases from intense to medium and in some cases is zero (scale from 10 to 0). 15 It was assumed that the patients indicated in rows 7 and 17 of the table were statistically the patients who were given the placebo tablets had a greater effect. The above mentioned patients were administered tablets according to the invention. The patient suffering from candidiasis was given 3 tablets of the compound according to the invention instead of 2. 1 57 0 0 4,7 0 23 2 57 0.5 0 4.7 0 24 3 54 0.5 0 4.7 0 23 4 46 0 0 4.7 0 25 5 54 0 0 4.7 2 24 Fibromyalgia 6 58 0.5 1 4.7 0 24 7 59 2 1.5 5.2 4 18 Chemotherapy oncology 8 55 0 0 5, 0 24 Sample Age [30-75] Nuisance [0-3] Itching [0-3] pH Pain [0-10] Burning VHI [5-25] Dryness Atrophy Other patient pathologies 9 57 0 0 5, 0 23 10 62 0 0 5, 0 23 11 50 0 0 5, 0 25 12 46 3 3 6.0 5 10 Candida 13 66 0.5 0 5, 0 23 14 35 0 0 5.7 0 24 Postpartum / breastfeeding 15 55 0 0 5, 0 23 16 53 0 0 5, 0 23 17 50 3 2 5.2 6 20 18 55 0 0 4.7 2 24 19 36 0 0 4.7 0 23 Postpartum / breastfeeding 20 59 0 0 4.7 0 25 21 54 0 0 4.7 0 25 22 39 0 0 4.7 2 24 23 35 0 0 4.7 0 24 Postpartum / breastfeeding 24 62 0 0 4.7 0 23 25 58 0 0 4.7 2 24 26 40 0 ​​0 4.7 1 24 Chemotherapy oncology 27 75 0.5 0 5.0 1 23 28 50 0 0 4.8 0 25 29 30 0 0.5 4.5 0 25 Table 4: Summary of validated patient symptom questionnaires completed by patients after 60 days of administration of the compound according to the invention. 5 The use of the compound according to the present invention leads to the reduction of the majority part of the values ​​associated with these pathologies: - the vaginal health index (VHI) increases from a value of approximately 7 before treatment to an average value of approximately 24 after 60 days of administration; - vaginal pH decreases from a value greater than 5.0 to an average value close to 10 normality which is an indication of a normal, unaltered vaginal balance; - vaginal dryness decreases as well as vaginal atrophy; - itching decreases from moderate to none with some cases persisting in a mild form (scale from 3 to 0); - the burning sensation decreases from moderate to non-existent with some cases where it persists in a mild form (scale from 3 to 0) 5 - the VAS for pain associated with sexual intercourse decreases from moderate to none (scale from 10 to 0) in most cases. After administration of the tablets according to the invention, the patients also indicated in lines 7 and 17 have experienced the benefits of the treatment. Treatment with a higher dose (3) of tablets according to the invention has 10 demonstrated beneficial effects on the patient suffering from candidiasis. For these three patients, treatment with the compound according to the invention was continued for a further 60 days at the end of which the pathologies had disappeared and also the candidiasis had been cured. All patients who participated in the clinical study continued the 15 preventive maintenance treatment to avoid the recurrence of the disease taking a tablet of the compound according to the invention alternating cycles of intake two-month cycles of rest lasting one month. The compound of the present invention is useful in the prevention and / or treatment of symptoms associated with vaginal dryness and atrophy, when taken at least once 20 per day, preferably twice a day, for a period of at least 60 days. The effectiveness is maintained with a maintenance treatment of one, two or three times / week. Maintenance treatment may be continued for one, two or three months and / or until need. The treatment can be repeated with cyclic treatments. The compound of the present invention is useful in the prevention and / or 25 in the treatment of patients who have symptoms associated with vaginal atrophy and dryness in perimenopause, menopause, pregnancy, breastfeeding or who have undergone surgery gynecological. The compound is also useful in the prevention and / or treatment of patients treated with chemotherapy or radiotherapy, or have diabetes or use antidepressants. The compound according to the invention leads in particular to a relief, for example, of 30 itching, discomfort with a simultaneous reduction in pain and pathologies. Patients report significant improvement in symptoms, and the compound is well accepted without any side effects on patients. A feature of the compound according to the invention is that it is substantially free of side effects and has excellent tolerability even with a therapeutic approach long term. The compound according to the invention can therefore be used both as part of a 5 monotherapy that in combination with other preparations, the dose and duration of use of which can be reduced thanks to the adjuvant effect of the compound according to the invention. According to the invention particularly good results regarding efficacy of the compound according to the invention are obtained with Magnesium phosphoricum (phosphate of magnesium) 250 mg. 10 The results demonstrated a notable effectiveness of the product on dryness vaginal and on all other symptoms and signs with a statistically significant production from the first weeks of treatment. However, in individual cases or in relation to the application, it may be necessary deviate from the quantities indicated above without the expert in the sector leaving the scope of the 15 present invention. All treated subjects experienced partial or total disappearance of the prodromes vaginal dryness, i.e. burning, tingling and / or itching and pH > 5. In summary, from the above data it is clear that the compound according to the invention It is effective in preventing and / or treating vaginal dryness. Furthermore, the data reported above 20 demonstrate that this compound is also effective in preventing relapses due to reactivation of the aforementioned pathologies and infections. The invention as described and illustrated is susceptible to numerous modifications and variations falling within the same inventive principle = = = = = = = = =

Claims

CLAIMS l.Magnesium phosphate or a composition containing magnesium phosphate for use in the therapeutic treatment and / or prevention of vaginal atrophy.

2. Magnesium phosphate or a composition containing magnesium phosphate for use according to claim 1, wherein vaginal atrophy is associated with vaginal dryness.

3. Magnesium phosphate or a composition containing magnesium phosphate for use according to claim 1 or 2, wherein the vaginal atrophy results from an alteration of the pH outside the range between pH 3.5 and pH 4.

5.

4. Magnesium phosphate or a composition containing magnesium phosphate for use according to claim 1 or 2 or 3, wherein vaginal atrophy is caused by an alteration of the skin lipids and a loss of water from the superficial skin layer of approximately 25% of the normal content.

5. Magnesium phosphate or a composition containing magnesium phosphate for use according to claim 1 or 2 or 3 or 4, wherein vaginal atrophy is associated with vaginal dryness due to the lack of natural lubrication of the vagina and is caused by: menopause, stress, pregnancy, puerperium, breastfeeding, hypoestrogenism, vascular disorders, heart disease, diabetes, chemotherapy, radiological treatments, autoimmune diseases such as, for example, Sjogren's syndrome, contraceptive treatments, vulvovaginitis, candidiasis.

6. Magnesium phosphate or a composition containing magnesium phosphate for use according to any of claims 1 to 5, administered in the form of a pharmaceutical composition, together with one or more pharmacologically acceptable excipients.

7. Magnesium phosphate or a composition containing magnesium phosphate for use according to any of claims 1 to 5, wherein said therapeutic treatment comprises oral administration.

8. A pharmaceutical composition containing magnesium phosphate for use according to any of the preceding claims, wherein said composition contains a pharmacologically effective percentage of magnesium phosphate and at least one excipient, or a pharmacologically acceptable carrier or diluent.

9. Pharmaceutical composition containing magnesium phosphate for use according to claim 8, wherein said composition comprises the seventh of the Schussler salts.

10. Pharmaceutical composition containing magnesium phosphate for use according to claim 9, wherein said composition comprises a pharmacologically effective amount of Magnesium phosphoricum D6 Salt Dr. Schussler No.7.