Abstract: A method of contraception that provides for sequentially administering to a female of child bearing age: (a) a first composition containing a progestin 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 20 mcg of ethinyl estradiol for about 22 to about 26 days; (b) a second composition containing an estrogen in an amount equivalent to about 5 to about 20 mcg of ethinyl estradiol for about 2 to about 3 days and an optional third composition that is a placebo provided that (i) if estrogen administration is continuous then the first composition is administered for 25 to 26 days, the second composition is administered for 2 to 3 days and no third composition is administered and (ii) if estrogen administration is not continuous then the first composition is administered for 22 to 24 days, the second composition is administered for 2 to 3 days and the third composition is administered for 1 to 4 days.

Abstract: Menses regulation and, when desired, contraception is achieved at low doses of estrogen and progestin, which otherwise would create episodes of breakthrough bleeding and/or withdrawal amenorrhea, by periodically inducing menses with an antiprogestin.

Abstract: A method of producing a tablet which comprises sterols and stanols includes the steps of forming the sterols and/or stanols, separately or together, into spherically-shaped, substantially uniform beads or prills and directly compressing the beads or prills into a tablet core.

Abstract: A pharmaceutical composition comprising as a first active ingredient an estrogen, such as estradiol or estradiol valerate, in sufficient amounts to treat disorders and symptoms associated with deficient endogenous levels of estrogen in women, and as a second active ingredient 6?,7?;15?;16?-dimethylene-3-oxo-17?-preg-4-ene-21,17-carbolactone (drospirenone, DRSP) in sufficient amounts to protect the endometrium from the adverse effects of estrogen is useful for, amongst others, treating peri-menopausal, menopausal and post-menopausal women. This composition may be used for hormone replacement therapy and may be administered as a multi-phased pharmaceutical preparation. This combination therapy may comprise continuous, sequential or interrupted administration, or combinations thereof, of DRSP and estrogen, each optionally in micronized form.

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: This invention is directed to an oral modified release formulation of the phytoestrogen 8-Prenylnaringenin in combination with a progestin, preferably with Drospirenone, and several uses thereof. In another aspect of the invention an oral modified formulation of 8-Prenylnaringenin with an immediately releasing progestin, like Drospirenone, is provided as well as several uses thereof.

Abstract: Methods and compositions for enhancing the activity and/or duration of action of loteprednol etabonate and other soft anti-inflammatory steroids of the haloalkyl 17?-alkoxycarbonyloxy-11?-hydroxyandrost-4-cn-3-one-17?-carboxylate type and the corresponding ?1,4-compounds are described. The enhancing agents have the formula: wherein Z1 is carbonyl, ?-hydroxymethylene or methylene; R2 is H, —OH or —OCOR3 wherein R3 is C1-5 alkyl; Y is —OH, —SH or —OCOR4 wherein R4 is C1-5 alkyl, cyclopentylethyl or diethylaminoethyl; and the dotted line in ring A indicates that the 1,2-linkage is saturated or unsaturated. Ophthalmic administration in the treatment of dry eye is specifically targeted.

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: A process for preparing a processed ginseng extract with enhanced pharmacological effects due to subsequent treatment is disclosed. The subsequent treatment includes an acid-treatment of ginseng and a bio-converting treatment, such as a lactic acid bacterial fermenting and an intestinal bacterial fermenting process.

Abstract: Methods and compositions for enhancing the activity and/or duration of action of loteprednol etabonate and other soft anti-inflammatory steroids of the haloalkyl 17?-alkoxycarbonyloxy-11?-hydroxyandrost-4-en-3-one-17?-carboxylate type and the corresponding ?1,4-compounds are described. The enhancing agents have the formula: wherein Z1 is carbonyl, ?-hydroxymethylene or methylene; R2 is H, —OH or —OCOR3 wherein R3 is C1-C5 alkyl; Y is —OH, —SH or —OCOR4 wherein R4 is C1-C5 alkyl, cyclopentylethyl or diethylaminoethyl; and the dotted line in ring A indicates that the 1,2-linkage is saturated or unsaturated.

Abstract: The present invention relates to the use of at least one gestagen selected from the group consisting of chlormadinone acetate, 3?-hydroxy-6-chloro-17?-acetoxy-4,6-pregnadien-20-one (3?-hydroxy-chlormadinone acetate) and 3?-hydroxy-6-chloro-17?-acetoxy-4,6-pregnadien-20-one (3?-hydroxy-chlormadinone acetate) as gestagen component and optionally at least one oestrogen selected from the group consisting of ethinyl oestradiol, oestrone, oestriol as oestrogen component and oestradiol to produce a medicament for the treatment and/or prevention of melasma and optionally for simultaneous hormonal contraception or optionally for simultaneous hormone replacement for women.

Abstract: The present invention refers to a medicament which activates gastrointestinal movement. The medicament consists essentially of Cucurbitacin D and one or more substances form the group including Cucurbitacin A, Cucurbitacin B, Cucurbitacin E, Isocucurbitacin B and Isocucurbitacin D. The medicament is made from an extract obtained from Muskmelon Base, the fruit stem of Cucumis melo L. The medicament can promote enterokinesia in both normal animals and in animal models where gastrointestinal movement is inhibited. It has also been demonstrated to activate the movements of the stomach, small and large intestines. The extract may be used alone or in combination with the other botanical ingredients or chemical substances to form the pharmaceutical preparation.

Abstract: The present invention relates to methods for modulating progestagen signaling for treating neurological disorders or neurodegenerative disease, or preventing or delaying its onset in individuals deemed by competent observation and testing to be susceptible thereto. Progestagens can be administered to elevate serum and brain levels of progestagens and induce neurogenesis. Progestagen therapy may prevent some of the neurodegenerative and cognitive changes associated with developmental and aging associated neurological disorders and neurodegenerative diseases. Progestagen therapy together with suppression of GnRH, kisspeptin, LH and/or FSH signaling also may be used for treating neurological disorders or neurodegenerative diseases. The invention also relates to methods for inhibiting or delaying blastulation during embryogenesis, and neurogenesis during embryogenesis, fetal, neonatal, childhood, puberty or adult life.

Abstract: The present invention relates to compositions comprising the triterpenes, dihydrobutyrospermol, dihydrolupeol and/or dihydroparkeol, the composition being applicable as a pharmaceutical, a dietary supplement or as a cosmetic. Further, the invention relates to the use of such compositions for the preparation of a medicament, a dietary supplement or a cosmetic for immunomodulating in a mammal such as suppression of viral infections, cardiovascular diseases, cancer, hypersensitivity and/or inflammatory reactions. The triterpenes may be in form of the free alcohol or derivatised, preferably with cinnamic acid, acetic acid or fatty acids. Furthermore, the triterpenes may be an extract obtainable from a natural source or synthetically made.

Abstract: A method, device, or kit is provided which maintain a substantially physiological cyclic pre-menopausal level of one or more steroid hormones in a mammalian subject in need thereof. The method, device, or kit includes providing to the subject at least one treatment regimen including replacement therapy for the one or more steroid hormones or metabolites or modulators thereof, wherein the at least one treatment regimen is determined based on pre-menopausal cyclic steroid hormone levels of the subject and on current cyclic steroid hormone levels of the subject, wherein the at least one treatment regimen is configured to maintain the subject's one or more steroid hormones or metabolites or modulators thereof at substantially physiological cyclic pre-menopausal levels. The method, device, or kit can be used for the treatment of a disease or condition in the mammalian subject.

Abstract: The present invention relates to methods for continuous treatment of diseases, conditions and/or symptoms associated with deficient endogenous levels of estrogen in a woman already receiving a therapeutically effective dose of an estrogen. More particularly, the present invention provides a safe and efficient step-down regimen for women already receiving estrogen therapy and which are potentially overdosed.

Abstract: A method, device, or kit is provided which maintain a substantially physiological level of one or more steroid hormones in a mammalian subject in need thereof. The method, device, or kit includes providing to the subject at least one treatment regimen including replacement therapy for the one or more steroid hormones or metabolites or modulators thereof, wherein the at least one treatment regimen is determined based on steroid hormone levels prior to disease diagnosis in the subject and on current steroid hormone levels in the subject, wherein the at least one treatment regimen is configured to maintain the subject's one or more steroid hormones or metabolites or modulators thereof at substantially physiological pre-disease levels. The method, device, or kit can be used for the treatment of a disease or condition in the mammalian subject.

Abstract: A method, device, or kit is provided which maintain a substantially physiological cyclic pre-menopausal level of one or more steroid hormones in a mammalian subject in need thereof. The method, device, or kit includes providing to the subject at least one treatment regimen including replacement therapy for the one or more steroid hormones or metabolites or modulators thereof, wherein the at least one treatment regimen is determined based on pre-menopausal cyclic steroid hormone levels of the subject and on current cyclic steroid hormone levels of the subject, wherein the at least one treatment regimen is configured to maintain the subject's one or more steroid hormones or metabolites or modulators thereof at substantially physiological cyclic pre-menopausal levels. The method, device, or kit can be used for the treatment of a disease or condition in the mammalian subject.

Abstract: The present invention comprises a composition and methods for treating eye conditions using a composition having a therapeutically effective amount of a progestagen, or a therapeutically effective amount of a progestagen with a testosterone; and pharmaceutically acceptable carrier, wherein the composition is applied to the palpebral part of the eye and/or ocular surface.

Abstract: The methods provided herein comprise administering a selective progesterone receptor modulator (SPRM) during a first dosing period and at least one progestogen during a second dosing period. The dosing periods can run concomitantly or sequentially with or without a period where neither the SPRM nor the progestogen is administered.

Abstract: A transdermal hormone delivery system (THDS) is disclosed. The THDS is useful for control of fertility and as therapy for a variety of diseases and conditions treatable by robust delivery of progestin and estrogen hormones, particularly the progestin, levonorgestrel. The THDS comprises a backing layer, an adjoining adhesive polymer matrix comprising an effective amount of at least a progestin hormone, delivery of which is enhanced by one or more skin permeation enhancing agents present in pre-determined amounts. The THDS is capable of providing effective daily doses of progestin and estrogen hormones from a small surface area in contact with the skin, e.g., less than 20 square centimeters. Methods of fertility control and various types of hormone replacement therapy utilizing the THDS are also disclosed.

Abstract: The present invention relates to the use of 3?-hydroxychlormadinone acetate (17?-acetoxychloropregna-4,6-dien-3?-ol-20-one) and/or 3?-hydroxychlormadinone acetate (17?-acetoxychloropregna-4,6-dien-3?-ol-20-one) for producing a medicament for treating skin, preferably human skin by means of topical application, and to a pharmaceutical or cosmetic composition containing 3?-hydroxy-chlormadinone acetate and/or 3?-hydroxychlormadinone acetate.

Abstract: A pharmaceutical or veterinary composition, comprises a first active agent selected from a dehydroepiandrosterone and/or dehydroepiandrosterone-sulfate, or a salt thereof, and a second active agent comprising a glucocorticosteroid for the treatment of asthma, chronic obstructive pulmonary disease, allergic rhinitis, or any other respiratory disease. The composition is provided in various formulations and in the form of a kit. The products of this patent are applied to the prophylaxis and treatment of asthma, chronic obstructive pulmonary disease, or any other respiratory disease.

Abstract: A process for the recovery and purification of natural hydrophilic water-soluble products in conjugated form from vegetable aqueous extracts or physiological fluids, by adsorption of the extracts or fluids on a lipophilic resin, followed by desorption and recovery of the eluate, which process is characterized in that the resin is a porous styrene-divinyl benzene polymer brominated at the styrene and/or divinylbenzene portion, with 600 m2/g area, 1.3 ml/g volume (dry weight), about 200 Angstrom pore size.

Abstract: The use of mesoprogestins as pharmaceutical components for the manufacture of a medicament for hormone replacement therapy (HRT) and as components for the combined use together with an estrogen for the manufacture of a medicament for HRT as well as in respective HRT-methods and methods of treating hormone deficiency and hormone irregularity symptoms. Mesoprogestins are defined as compounds possessing both agonistic and antagonistic activities at the progesterone receptor (PR) in vivo. They stabilize the function of PR at an intermediate level of agonistic and antagonistic. Corresponding functional states cannot be achieved with progestins or antiprogestins. J867, J912, J956 and J1042 are the mesoprogestins preferred herein.

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: A multiphasic contraceptive kit is disclosed that may be used to practice a multiphasic method of contraception that provides for sequentially administering to a female of child bearing age: (a) a Phase I composition containing a progestogen in an amount equivalent to about 0.5 to about 1.5 mg norethindrone acetate and an estrogen in an amount equivalent to about 5 to about 30 mcg of ethinyl estradiol for about 4 to about 7 days; (b) a Phase II composition containing a progestogen in an amount equivalent to about 0.5 to about 1.5 mg of norethindrone acetate and an estrogen in an amount equivalent to about 10 to about 40 mcg of ethinyl estradiol for about 8 to about 16 days; (c) a Phase III composition containing a progestogen in an amount equivalent to about 0.5 to about 1.

Abstract: This invention relates to a method of preventing pregnancy and treating PMS including PMDD. More particularly, the invention relates to a method, which involves administering one of several combination oral contraceptive regimens in combination with an antidepressant and a kit containing the same.

Abstract: The invention relates to an drug delivery device and a method for delivering multiple drugs over a prolonged period of time. The drug delivery device has two or more unitary segments comprising a drug-permeable polymeric substance, wherein at least one of the segments further comprises a pharmaceutically active agent. The invention also relates to a method for the treatment of a benign ovarian secretory disorder in a female mammal, a method of contraception, and a method of relieving the symptoms associated with menopausal, perimenopausal and post-menopausal periods in a woman.

Abstract: Polish compositions for coating pharmaceutical solid dosage forms such as tablets are disclosed. The polish composition comprises water, coating agent, and a film forming agent. Polished pharmaceutical solid dosage forms such as tablets comprising a polished exterior surface are also disclosed. Processes of polishing pharmaceutical solid dosage forms such as tablets are disclosed.

Abstract: Disclosed herein are oral dosage forms and methods of their use, in particular oral dosage systems for the delivery of drugs for use as a female oral contraceptive. In an embodiment, an oral dosage form includes a progestogen dispersed in an enteric polymer and an estrogen.

Abstract: The invention relates to pharmaceutical compositions and administration forms, which contain compounds of the general formula (I) and methods for contraception by administering these administration forms. The invention additionally relates to compounds of the general formula (I) as medication and the use of these compounds for the production of drugs for hormone replacement therapy.

Abstract: The present invention provides an enhanced gelling agent composition comprising a mixture of an anionic surfactant and a coupling agent. The invention also describes compositions in gel form comprising: (a) a solvent selected from the group consisting of polar solvents, non-polar solvents and combinations thereof; and (b) a gelling agent in an amount sufficient to impart gelation to the composition, the gelling agent being a mixture comprising an anionic surfactant and a coupling agent. The gels of the invention may be substantially anhydrous or may optionally contain water as part of the formulation.

Abstract: A method for treating an inflamed tissue includes locally applying a solution comprising a corticosteroid and an anesthetic agent to the inflamed tissue so that the solution directly contacts the inflamed tissue. The corticosteroid may be a 4 mg/ml dexamethasone solution and the anesthetic agent may be a 1% lidocaine solution. The dexamethasone solution and the lidocaine solution may be mixed in a 1 to 3 ratio. Locally applying the solution may include penetrating the skin with a hypodermic needle, directing the hypodermic needle parallel to and past the inflamed tissue, and while withdrawing the hypodermic needle, spraying the solution directly onto the surface of the inflamed tissue.

Abstract: The present invention relates to methods of stimulating estrogen production that can be used to treat peri-menopausal or estrogen deficiency conditions utilizing regimens involving administration of estrogen and progestin, followed by a hormone-free period.

Abstract: Methods and compositions for enhancing the activity and/or duration of action of loteprednol etabonate and other soft anti-inflammatory steroids of the haloalkyl 17?-alkoxycarbonyloxy-11?-hydroxyandrost-4-en-3-one-17?-carboxylate type and the corresponding ?1,4-compounds are described. The enhancing agents have the formula: wherein R is H or C1-C4 alkyl; Z1 is carbonyl or ?-hydroxymethylene; X1 is —O— or —S—; R5 is —OH, —OR6, —OCOOR6 or —OCOR7 wherein R6 is C1-C4 alkyl and R7 is C1-C4 alkyl, fluoromethyl or chloromethyl; and the dotted line in ring A indicates that the 1,2-linkage is saturated or unsaturated; with the proviso that when R is C1-C4 alkyl, then R5 is —OH.

Abstract: The present invention provides slow release estradiol-progesterone formulations that can be used in either contraception or hormone replacement therapies. The formulations comprise shaped particles of estradiol that is in a hemicrystalline form that exhibits especially low dissolution rates. The shaped particles comprise estradiol compounded in a 1:1 molar ratio with cholesterol, and are administered in combination with progesterone. The slow release formulations of the present invention afford the dual advantages of a low dose estradiol formulation with a low frequency administration regimen. The formulations can be parenterally administered once a month or less often.

Abstract: A pharmaceutical composition of drospirenone and ethynylestradiol with an improved dissolution rate. A method of preparation of a pharmaceutical formulation of drospirenone and ethynylestradiol in order to improve its dissolution profile. The formulation can be used to produce an anovulatory effect when administered correctly in humans.

Abstract: The present invention is directed generally to pharmaceutical compositions, methods, and kits for improving side effects associated with aromatase inhibitor treatment in a subject diagnosed with breast cancer. More specifically, the present invention provides compositions, methods, and kits comprising an aromatase inhibitor and an androgenic agent.

Abstract: A pharmaceutical dosage unit for oral administration to a human female comprising a therapeutically effective amount of 17?-estradiol-3-lower alkanoate, most preferably 17?-estradiol-3-acetate, and a pharmaceutically acceptable carrier is disclosed. Also disclosed is a method for treating a human female in need of 17?-estradiol and a contraceptive method by oral administration of the pharmaceutical dosage unit and a method of preparing a pharmaceutical composition that may be used to form the pharmaceutical dosage unit of the invention.

Abstract: The present invention provides a therapeutic agent for neuropathic pain having an excellent treating effect on neuropathic pain, which is an intractable disorder. More specifically, the present invention provides a therapeutic agent for neuropathic pain and a pharmaceutical composition for treating neuropathic pain, comprising (1) a compound having an anti-progesterone activity (for example, fulvestrant (ICI182.780), fluocinolone acetonide, triamcinolone acetonide, etc.), (2) a compound having an estrogen activity (for example, 17?-estradiol), or (3) a mixture of a compound having an anti-progesterone activity and a compound having an estrogen activity (for example, 17?-estradiol and fulvestrant), as an active ingredient; a method for treating neuropathic pain using such a compound, and the like.

Abstract: A multiphasic method of contraception provides for sequentially administering to a female of child bearing age: (a) a Phase I composition containing a progestogen and an estrogen for about 4 to about 7 days; (b) a Phase II composition containing a progestogen and an estrogen for about 8 to about 16 days; (c) a Phase III composition containing a progestogen and an estrogen for about 4 to about 7 days; and (d) optionally, a Phase IV composition which is a placebo or a non-steroidal component, wherein the ethinyl estradiol equivalent amount of estrogen in the Phase II composition is at least 5 mcg greater than the ethinyl estradiol equivalent amount of estrogen in each of the Phase I and III compositions. Preferably the sequential administration is repeated the day following the completion of the administration of the Phase III compositions providing an extended cycle multiphasic oral contraceptive method.

Abstract: This invention generally relates to a method for promoting growth and increasing feed utilization efficiency in animals, and, more specifically, to combinations comprising zilpaterol (and salts thereof) and melengestrol acetate. Included within this invention are treatment methods comprising the administration of such combinations to animals, compositions comprising such combinations, uses of such combinations to prepare medicaments, and kits for using such combinations.

Abstract: A transdermal drug delivery device comprising an adhesive matrix, an effective amount of drospirenone, and an oligomeric adjuvant selected from an oligolactic acid, oligolactic acid derivatives, or mixtures thereof. Also, a transdermal drug delivery device comprising a backing film and an adhesive matrix which comprises an effective amount of drospirenone, a solubilizing agent, and a permeation enhancer selected from the group consisting of alkyl lactates, carboxylic acids, alkyl esters of fatty acids, and mixtures thereof.

Abstract: Methods and compositions for treating retinal edema and NPDR are disclosed.

Abstract: Methods and compositions for enhancing the activity and/or duration of action of loteprednol etabonate and other soft anti-inflammatory steroids of the haloalkyl 17?-alkoxycarbonyloxy-11?-hydroxyandrost-4-en-3-one-17?-carboxylate type and the corresponding ?1,4-compounds are described. The enhancing agents have the formula: wherein R is H or C1-C4 alkyl; Z1 is carbonyl or ?-hydroxymethylene; X1 is —O— or —S—; R5 is —OH, —OR6, —OCOOR6 or —OCOR7 wherein R6 is C1-C4 alkyl and R7 is C1-C4 alkyl, fluoromethyl or chloromethyl; and the dotted line in ring A indicates that the 1,2-linkage is saturated or unsaturated; with the proviso that when R is C1-C4 alkyl, then R5 is —OH.

Abstract: The present invention comprises a composition, method of enhancing potency and method of delivering corticosteroids in a vehicle comprising at least two penetration enhancers, and solvents and emulsifiers. The propylene glycol and penetration enhancers are present in ratio to the total of the propylene glycol, penetration enhancers, and solvents and emulsifiers of at least about 0.70.

Abstract: The present invention relates to methods of step-down hormone treatment in which an estrogen and progestin combination regimen is administered for one or more cycles prior to administration of a lower dose hormone regimen containing a lower daily dosage amount of estrogen and/or progestin.

Abstract: Described are methods for providing prolonged physiologically acceptable steady state serum testosterone levels in a patient deficient in endogenous testosterone levels, methods for male contraception and methods for treating a disease or symptom associated with deficient endogenous levels of testosterone in a man, by intramuscularly administering testosterone esters in a vehicle.

Abstract: The present invention provides for methods of treating cancer comprising administering a topical active corticosteroid in conjunction with a form of non-myeloablative conditioning, wherein the above regimen results in a reduction or elimination of cancer cells in an individual.