Abstract: Methods for enhancing the ability of an individual, exposed to sunlight, to produce vitamin D via the skin. Pharmaceutical compositions comprising provitamin D and at least one of lumisterol and tachysterol and analogs and derivatives thereof are also disclosed.

Abstract: Use of a mixture of phytosterols, selected from the group comprising: brassicasterol (Delta 5-C22 unsaturated); campesterol; campestanol; stigmasterol (Delta 5-C22 unsaturated); Delta 5-C23-stigmastadienol; clerosterol (Delta 8-C25 unsaturated); Beta-sitosterol; sitostanol; Delta 5-venasterol (Delta 5-C24 unsaturated); Delta 5-C24-stigmastadienol (Delta 5-C24 diene unsaturated); Delta 7-stigmastenol; 24-methylene-cycloartenol; gramisterol; 24-methylcholest-7-enol; isofucosterol; Delta 7-avenasterol (Delta 7-C24 unsaturated); Delta 5-avenastenol, for the manufacture of a medicament to induce into the adult organism proliferation and differentiation of the stem cells which are present in the organism.

Abstract: The present invention is directed to a medicinal composition for treating skin inflammations, fungal/bacterial skin infections and related wounds, and also other skin wounds including those caused by burns. The cream also causes skin rejuvenation through an epithelisation process. The cream comprises: a) a biopolymer in the form of Chitosan, b) active Pharmaceutical Ingredients (APIs), in the form of fusidic acid that has been generated in situ from sodium fusidate Hydrocortisone acetate & clotrimazole, c) a cream base containing primary and secondary emulsifiers, waxy materials, co-solvents, acids, preservatives, buffering agents, anti oxidants, chelating agents, and humectants and d) water. The invention also discloses a process to make medicinal cream containing Fusidic acid formed in situ from Sodium Fusidate by converting it into Fusidic acid under oxygen-free environment. The cream has greater shelf-life and the finer particle size of the API than the conventional creams containing Fusidic acid.

Abstract: A method of treating premenstrual dysphoric disorders comprising administering to a patient in need of such treatment daily from day 1 to day 24 3 mg of drospirenone and 0.02 mg of ethinylestradiol.

Abstract: The invention relates to a method for contraception comprising the administration of trimegestone to a woman of child-bearing age on at least 21 successive days, beginning on day 1 of the menstrual cycle, wherein on at least one of the at least 21 successive days the daily dose of trimegestone is more than 500 ?g.

Abstract: Dosing regimen for transdermal delivery of hormones comprising a 28 day treatment cycle with a fixed treatment interval and a fixed rest interval.

Abstract: This invention is directed to a hexahydro-cyclooctyl pyrazole cannabinoid modulator compound of formula (I): and a method for use in treating, ameliorating or preventing a cannabinoid receptor mediated syndrome, disorder or disease.

Abstract: The present invention relates to a pharmaceutical kit comprising a plurality of oral dosage units which comprise a progestogen. The progestogen is levonorgestrel, norgestimate, norethisterone, drospirenone, dydrogesterone, trimegestone, dienogest, precursors thereof and mixtures thereof. The kit comprises an amount of progestogen equivalent to 30-500 mg of levonorgestrel, 1-40 mg of ethinyl estradiol and 02-100 mg dehydroepiandrosterone.

Abstract: The present invention discloses administering steroid hormones to mammals to treat autoimmune related diseases, including post-partum auto immune diseases) and more particularly. Most preferably the invention uses estrogens, estranges, estriol or estrogen receptor active agents to prevent or ameliorate clinical symptoms of these ThI-mediated (cell-mediated) autoimmune diseases known to either have an initial onset following the birth of a child or which are exacerbated in patients in the postpartum period.

Abstract: The present invention relates to a medicament which contains as the active ingredient combination at least one gestagen with a contraceptive action as the sole hormone component and at least one insulin sensitizer, which medicament is in particular suitable for preventing or treating pathological disorders which are caused by polycystic ovary syndrome (PCOS).

Abstract: The subject invention pertains to the treatment of tumors and cancerous tissues and the prevention of tumorigenesis and malignant transformation through the modulation of JAK/STAT3 intracellular signaling. The subject invention concerns pharmaceutical compositions containing cucurbitacin I, or a pharmaceutically acceptable salt or analog thereof. Another aspect of the invention concerns methods of inhibiting the growth of a tumor by administering a cucurbitacin I, or a pharmaceutically acceptable salt or analog thereof, to a patient, wherein the tumor is characterized by the constitutive activation of the JAK/STAT3 intracellular signaling pathway. The present invention further pertains to methods of moderating the JAK and/or STAT3 signaling pathways in vitro or in vivo using cucurbitacin I, or a pharmaceutically acceptable salt or analog thereof. Another aspect of the present invention concerns a method for screening candidate compounds for JAK and/or STAT3 inhibition and anti-tumor activity.

Abstract: The invention describes methods of treating cancer in which a therapeutically-effective amount of a 17?-hydroxylase/C17,20-lyase inhibitor is administered to a subject in need thereof, including a subject with a refractory cancer and/or a subject currently undergoing another cancer treatment, wherein the 17?-hydroxylase/C17,20-lyase inhibitor is administered in combination with a therapeutically-effective amount of at least one additional therapeutic agent, including, but not limited to, another anti-cancer agent or a steroid.

Abstract: An ophthalmic instillation composition which contains melatonin and at least one other hormone, typically an estrogen but also possibly testosterone or another aromatasable androgen. The instillation is designed to reduce or eliminate cataracts in men or women to which such an ophthalmic instillation composition is administered.

Abstract: Dermatitis can be effectively treated with the combined administration of dehydroepiandrosterone (DHEA) and a glucocorticoid. Systemic, topical and prepackaged DHEA-glucocorticoid embodiments are described.

Abstract: Prodrugs of C-17-heterocyclic-steroidal drugs providing improved oral bioavailability and pharmacokinetics are described. The drugs are inhibitors of human CYP 17 enzyme, as well as potent antagonists of both wild type and mutant androgen receptors (AR), and are useful for the treatment of urogenital and/or androgen-related cancers, diseases and/or conditions, such as human prostate cancer, breast cancer, and prostate hyperplasia. The disclosure describes methods of synthesizing and using the prodrugs in cancer therapy.

Abstract: A method of treating preeclampsia including administering a therapeutically effective dose of resibufagenin to a patient having preeclampsia. Effecting the determination of the presence of preeclampsia may be by determining whether there has been a substantial elevation in marinobufagenin which may be blood-derived or urine-derived and if such elevation does exist, concluding that preeclampsia does exist. The method may advantageously be practiced by employing urine, blood serum or blood plasma as the body specimen containing the protein in determining whether a patient has preeclampsia. In another embodiment, bufodienolide derivatives other than resibufagenin may be employed in lieu of thereof or in combination therewith. In another embodiment, resibufagenin analogues may be employed in the treatment of preeclampsia.

Abstract: The invention provides methods to treating conditions such as prostate cancer, or for ameliorating one or more symptoms associated with prostate cancer, or for agents that modulate the biological activity of the androgen receptor. The invention also provides methods and compositions suitable for therapeutic applications.

Abstract: The multiphase preparation having higher contraceptive safety and reduced side effects is based on a combination of a natural oestrogen with dienogest or drospirenone. The multiphase preparation is characterized by a first phase consisting of 2 daily dose units of 3 mg of oestradiol valerate, a second phase consisting of 2 groups of daily dose units, wherein a first group is formed by 5 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least two or three times an ovulation-inhibitory dose of dienogest or drospirenone and a second group is formed by 17 daily dose units each containing a combination of 2 mg of oestradiol valerate and at least three or four times the ovulation-inhibitory dose of dienogest or drospirenone, a third phase consisting of 2 daily dose units of 1 mg of oestradiol valerate, and a further phase consisting of 2 daily dose units of pharmaceutically acceptable placebo.

Abstract: The present invention relates to a method of preventing or treating benign estrogen sensitive gynecological disorders in a female mammal, wherein the method comprises the administration to said female mammal of a combination of progestogen and androgen in an amount that is therapeutically effective to prevent or reduce the symptoms of these disorders. The present method is particularly suitable for preventing or treating disorders selected from the group consisting of endrometriosis, adenomyosis, uterine fibroids, dysmenorrhoea, menorrhagia and metrorrhagia. Another aspect of the invention relates to a pharmaceutical kit comprising a plurality of oral dosage units which comprise a progestogen in an amount equivalent to 3-500 ?g levonorgestrel and either 5 to 250 mg dehydroepiandrosterone or 1 to 50 mg testosterone undecanoate.

Abstract: A method of improving cumulative embryo score may comprise administering an androgen to a human female for at least about four consecutive months followed by harvesting and fertilizing oocytes and forming embryos. A method of increasing the quantity of fertilized oocytes in one cycle of in vitro fertilization may comprise administering an androgen to a human female for at least about four consecutive months, harvesting and fertilizing the oocytes. A method of normalizing ovarian DHEA may include administering an androgen for at least about four consecutive months. A method of decreasing the time to pregnancy and increasing the rate of pregnancy by administering an androgen for at least about two months. A method of decreasing miscarriage rates may comprise administering an androgen for at least about two months to a female. Moreover, a method of decreasing aneuploidy rates in human embryos may comprise administering an androgen to a female for at least about two months.

Abstract: Methods, formulations, and devices for providing transdermal or transmucosal delivery of active agents to subjects in need thereof. The formulations and methods treat symptoms of hormonal disorders including hypogonadism, female sexual desire disorder, female menopausal disorder, and adrenal insufficiency.

Abstract: Provided are methods for ameliorating a symptom of a neuropsychiatric disorder in a subject.

Abstract: A multiphasic method of contraception comprising the steps of sequentially administering to a female of child bearing age a Phase I composition containing a progestogen in an amount equivalent to about 0.3 to about 1.5 mg norethindrone acetate and an estrogen in an amount equivalent to about 5 to about 15 mcg of ethinyl estradiol for about 7 to about 14 days; a Phase II composition containing a progestogen in an amount equivalent to about 0.3 to about 1.5 mg of norethindrone acetate and an estrogen in an amount equivalent to about 10 to about 25 mcg of ethinyl estradiol for about 14 to about 22 days; a Phase III composition containing a progestogen in an amount equivalent to about 0.3 to about 1.

Abstract: The invention discloses a dermaceutical cream containing antifungal agents, steroids and an antibacterial agent in the form of Fusidic acid, which Fusidic acid is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is converted into Fusidic acid under oxygen-free environment. The cream of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid. The cream of the present invention contains Fusidic acid as the API that has been formed in situ from Sodium Fusidate, and steroids in a cream base comprising an acid, a co-solvent, an emulsifier and a waxy material along with water, preferably purified water.

Abstract: The invention discloses a dermaceutical cream containing steroids and an antibacterial agent in the form of Fusidic acid, which Fusidic acid is formed in situ from Sodium Fusidate as the starting raw material, wherein Sodium Fusidate is converted into Fusidic acid under oxygen-free environment. The cream of the present invention has greater shelf-life stability and the finer particle size of the API than the conventional creams containing Fusidic acid. The cream of the present invention contains Fusidic acid as the API that has been formed in situ from Sodium Fusidate, and steroids in a cream base comprising an acid, a co-solvent, an emulsifier and a waxy material along with water, preferably purified water.

Abstract: The present invention relates to a very low-dosed dosage form for hormone replacement therapy (HRT). More particularly, the present invention concerns a solid oral dosage form comprising about 0.5 mg estradiol and about 0.25 mg drospirenone, and at least one pharmaceutically acceptable excipient. Despite the very low E2 and DRSP doses it has surprisingly been found that a high proportion of the women suffering from moderate to severe hot flushes actually respond to this treatment. Accordingly, the dosage form of the invention may be used as maintenance HRT or may be used already when HRT is initiated.

Abstract: Novel estrogenic compounds of Formula I are provided. wherein the bond represented by the wavy line may be a single or double bond such that when the wavy line is a single bond, R1 is selected from the group consisting of hydrogen, sulfate and glucoronate or other esters, and when the wavy line is a double bond, R1 does not exist; R2 is lower alkyl; R3 may be selected from the group consisting of hydrogen, sulfate, or glucuronide or other esters; and R4 through R13 may independently be selected from the group consisting of hydrogen, hydroxy, ketone, lower alkyl, lower alkoxy, halogen, and carbonyl groups and R14 is selected from the group consisting of hydrogen, sulfate and glucoronide and other esters. When R1 is hydroxy, the hydroxy or ester substituent may have either an ? or a ? orientation. Compositions of matter including compounds of the present invention are also provided as are methods of treating mammals in need of treatment using compounds of the present invention.

Abstract: A method of preventing preeclampsia including administering to a patient during an early stage of pregnancy a prophylactically-effective amount of resibufogenin. The administration of resibufogenin is periodically repeated. The method serves to prevent hypertension, proteinuria, and intrauterine growth restriction.

Abstract: The invention provides, in part, polyhydroxylated bile acids for treating biliary disorders, for example, biliary disorders arising out of cholestasis or portal hypertension. The invention also provides, in part, polyhydroxylated bile acids for stimulating bile flow.

Abstract: Dosing regimen for transdermal delivery of hormones comprising a 28 day treatment cycle with a fixed treatment interval and a fixed rest interval.

Abstract: Dosing regimen for transdermal delivery of hormones comprising a monthly treatment cycle with a fixed treatment interval and a variable rest interval.

Abstract: Dosing regimen for transdermal delivery of hormones comprising a variable treatment cycle and a variable rest interval.

Abstract: The present invention relates to methods of mitigating, preventing or treating weight gain or obesity in patients by administering one or more autophagy inhibitors, thereby, preventing the differentiation process of pre-adipocyte cells into a mature adipocytes. Specifically, the present invention relates to the surprising discovery that autophagy is critical for the cellular remodeling required during pre-adipocyte differentiation into mature adipocyte. By targeting and inhibiting one or more mechanisms in autophagy, adipocyte maturation is also inhibited, thus, providing a novel a pathway to prevent, mitigate and/or treat weight gain, obesity and associated diseases, such as type II diabetes.

Abstract: The invention relates to a method of contraception, which method comprises administering to a woman in need thereof an emergency contraception during one or two days, followed by a prolonged low dosage contraceptive treatment until next menstrual period.

Abstract: One aspect of the present invention relates to a method of hormone replacement in mammals, which method comprises the oral administration of an estrogenic component and a progestogenic component to a mammal in an effective amount to prevent or treat symptoms of hypoestrogenism, wherein the estrogenic component is selected from the group consisting of substances represented by the above formula in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 1-5 carbon atoms; each of R5, R6, R7 is a hydroxyl group; and no more than 3 of R1, R2, R3, R4 are hydrogen atoms; precursors capable of liberating a substance according to the aforementioned formula when used in the present method; and mixtures of one or more of the aforementioned substances and/or precursors.

Abstract: The present invention provides a method for determining the gender of a fetus by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the maternal urine or other body fluid. The method can be used to determine fetal gender at any time point during the entire pregnancy. The body fluid may be processed before assaying. Processing may involve aging the body fluid, or purification of various fractions. The methods of the present invention also provide for a means for pre-conception offspring gender planning by assaying the sex hormones, evaluating the overall reducing/oxidizing (redox) activity, and/or evaluating the radical scavenging capacity of the urine or other body fluid from a non-pregnant female. The sex hormone profiles, the overall redox activity, and/or the radical scavenging capacity of a urine sample correlates with the gender specific compatibility of the ovum being released during a particular menstrual cycle.

Abstract: This invention relates to methods for using agents to inhibit peroxisome proliferator activated receptor expression.

Abstract: Provided is an antioxidant which is highly safe, inhibits oxidation of a biological component, in particular, a lipid, and may be used as a drug, food or drink, a food additive, an external preparation for skin, or the like. The antioxidant contains a compound selected from a cyclolanostane compound and a lophenol compound as an active ingredient.

Abstract: Compositions comprising a nanoparticulate corticosteroid and an antihistamine are described. The compositions are useful in the prophylaxis and chronic treatment of asthma in adults and pediatric patients and for the relief of allergic conjunctivitis, symptoms of seasonal allergic rhinitis in adults and pediatric patients. Combining an antihistamine with a nanoparticulate corticosteroid in a single formulation results in improved efficacy.

Abstract: A method is described herein for improving the overall health of a patient by providing subcutaneous pellets containing pregnenolone to at least one part of the body of the patient. In another embodiment, pregnenolone is mixed with DHEA into a cream and the resulting pregnenolone/DHEA cream is applied to at least one part of a body.

Abstract: Provided are methods and kits for administering progestogen as a glucocorticoid sensitizer to restore corticosteroid sensitivity or reverse the glucocorticoid insensitivity or enhance glucocorticoid sensitivity, in order to treat one or more glucocorticoid insensitivity related diseases or conditions. For example, these include methods for reversing the glucocorticoid insensitivity in a subject having no history of menstrual cycle-related exacerbation or allergy to self-hormones, particularly progesterone, such as premenstrual or perimenstrual deterioration in the symptoms, e.g., premenstrual worsening of atopic dermatitis or premenstrual exacerbations of asthma, and exhibiting relatively or totally refractory responses to glucocorticoid therapy, e.g., glucocorticoid resistance. The methods and kits provide for the administration of a sex hormone to the subject who is corticosteroid dependent or corticoid resistant or unresponsive or intolerant to corticosteroids.

Abstract: Methods of using 7?,11?-dimethyl-17?-hydroxy-4-estren-3 -one bucyclate (I) and 7?,11?-dimethyl-17?-hydroxyestr-4-en-3-one 17-undecanoate (II) for various hormonal therapies, dosage forms comprising 7?,11?-dimethyl-17?-hydroxy-4-estren-3-one bucyclate and 7?,11?-dimethyl-17?-hydroxyestr-4-en-3-one 17-undecanoate, and processes for their preparation.

Abstract: A method for treating an immunoinflammatory disorder in a subject in need thereof, said method comprising administering to said subject a unit dosage form comprising dipyridamole coated onto acid beads and formulated for controlled release. The method further including administering a corticosteriod concurrently with administration of the dipyridamole.

Abstract: A dosage form for hormonal contraception containing a given number of hormone-containing daily units and a given number of hormone-free daily units for daily, oral administration, where the hormone-containing daily units each contain at most the minimum effective daily amount of folic acid for women and the hormone-free daily units contain at least a multiple of this amount up to the maximum permissible amount of folic acid for women.

Abstract: The present invention provides compounds of formula (I) wherein n, p, R1, R2, X1, X2, X3, R3a, R3b, R4, R5 and R6 are as defined in the specification, a process for their preparation, pharmaceutical compositions containing them and their use in therapy.

Abstract: A formulation for drug delivery, providing enhanced modulation of solubility, stability, absorption, metabolism, and/or pharmacokinetic profile of a lipophilic therapeutic agent by formulation with sterols and/or sterol esters, resulting in higher bioavailability of a therapeutic agent administered to a subject in need of such therapeutic agent. The formulation contains a therapeutic agent and a sterol or sterol ester, and can, optionally, further contain a solubilizer and/or an enhancing agent. Also described are pharmaceutical compositions containing the formulations and methods of making and methods of using the formulations and pharmaceutical compositions. Formulations of the disclosure can be constituted to minimize the synthesis of dihydrotestosterone when the therapeutic agent includes testosterone or testosterone esters.

Abstract: A method for producing a high sapogenin content composition, including: allowing a strong acid aqueous solution having a concentration of 0.01 mol/L to 4 mol/L to act on a saponin-containing plant, so as to perform hydrolysis treatment; neutralizing a liquid obtained by the hydrolysis treatment; filtering the liquid so as to obtain a residue; and drying the residue.

Abstract: A transdermal drug-containing dosage unit comprises: a backing layer substantially impervious to the drug to be delivered transdermally; a first polymeric adhesive matrix, in contact with the backing layer, having dispersed therein the drug and having a first delivery profile of the drug; a second polymeric adhesive matrix, in contact with said first polymeric adhesive matrix, having dispersed therein the drug and having a second delivery profile of the drug, wherein said second delivery profile is different from said first delivery profile; and a release liner in contact with the second polymeric adhesive matrix. The first polymeric adhesive matrix can release the drug more quickly or more slowly than the second polymeric adhesive matrix. Through the selection of the two matrices, the delivery profile of the drug through the skin can be selectively modified and controlled.

Abstract: A method for obtaining an extract containing the natural mixture of conjugated equine estrogens in which a mixture of conjugated estrogens obtained by solid-phase extraction from pregnant mares' urine is depleted in phenolic urine contents and in non-conjugated lipophilic compounds selected from the group consisting of non-conjugated flavonoids, non-conjugated isoflavonoids, non-conjugated norisoprenoids, non-conjugated steroids, in particular androstane and pregnane steroids, and comparable non-conjugated compounds.

Abstract: Methods and compositions for treating cancer are described herein. More particularly, the methods for treating cancer comprise administering a 17?-hydroxylase/C17,20-lyase inhibitor, such as abiraterone acetate (i.e., 3?-acetoxy-17-(3-pyridyl) androsta-5,16-diene), in combination with at least one additional therapeutic agent such as an anti-cancer agent or a steroid. Furthermore, disclosed are compositions comprising a 17?-hydroxylase/C17,20-lyase inhibitor, and at least one additional therapeutic agent, such as an anti-cancer agent or a steroid.