Abstract: The invention relates to pharmaceutical dosage units for oral, transmucosal or transdermal administration containing 15- or 16-substituted testosterone analogues, as well as to therapeutic methods that employ these testosterone analogues. More particularly, the invention is concerned with such pharmaceutical dosage units containing at least 10 ?g of an androgenic steroid selected from the group consisting of 15-hydroxytestosterones, 16-hydroxytestosterones, precursors thereof and mixtures of these hydroxytestosterones and/or their precursors; and a pharmaceutically acceptable excipient. The term “15-hydroxytestosterones” encompasses both 15?-hydroxytestosterone (15?, 17?-dihydroxy-4-androsten-3-one) and 15?-hydroxytestosterone (15?, 17?-dihydroxy-4-androsten-3-one). Similarly, the term “16-hydroxytestosterones” encompasses both 16?-hydroxytestosterone hydroxytestosterone (16?, 17?-dihydroxy-4-androsten-3-one) and 16?-hydroxytestosterone (16?, 17?-dihydroxy-4-androsten-3-one).

Abstract: The invention relates to cosmetic methods of treating human skin. The method includes applying to the skin a composition containing an estrogenic component and a cosmetically acceptable vehicle. Other aspects of the invention relate to therapeutic methods of treating or preventing vaginal dryness or acne and a therapeutic method of promoting wound healing. Another aspect relates to a skin care composition comprising the aforementioned estrogenic component and a cosmetically acceptable vehicle.

Abstract: A method of treating or preventing an immune mediated disorder in a mammal, said method comprising the administration of a therapeutically effective amount of an estrogenic component to said mammal, wherein the estrogenic component is selected from the group consisting of: substances represented by the following 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; 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. Another aspect of the invention relates to a pharmaceutical formulation comprising the aforementioned estrogenic component, an immunotherapeutic agent and a pharmaceutically acceptable excipient.

Abstract: A method of contraception in mammalian females, which method comprises the parenteral or rectal administration of an estrogenic component and a progestogenic component to a female of childbearing capability in an amount effective to inhibit ovulation, wherein the estrogenic component is selected from the group consisting of substances represented by the following formula (1) in which 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: One aspect of the present invention is concerned with a method of controlled ovarian hyperstimulation in a mammalian female, said method comprising the co-administration to said female of —a substance having follicle stimulating hormone activity (FSH substance) in an amount effective to stimulate multiple follicular development; —gonadotropin releasing hormone (GnRH) antagonist in an amount equivalent to a daily subcutaneous dose of at least 0.5 mg ganirelix to prevent a premature LH-surge; and —a LH substance in an amount effective to prevent or suppress symptoms of luteinising hormone (LH) deficiency resulting from the administration of the GnRH antagonist; followed by administering a meiosis and luteinisation inducing substance (ML substance) in an amount effective to stimulate resumption of meiosis and luteinisation, and wherein the LH substance is not obtained from the urine of human females.

Abstract: One aspect of the present invention relates to the use of an estrogen in the treatment of Meconium Aspiration Syndrome (MAS) in a newborn infant, said treatment comprising administering an effective amount of estrogen to said newborn infant within 7 days after birth. The present treatment offers the advantage that estrogens can be administered using non-invasive modes of administration, e.g. oral or rectal administration. Other aspects of the present invention relate to a suppository for use in newborn infants comprising at least 1 ?g of estrogen and to an oral applicator comprising a container holding an aqueous liquid containing micronised estetrol and a metering dispenser for metering the liquid into the oral cavity of a newborn infant.

Abstract: A method of contraception in mammalian females, which method comprises the oral administration of an estrogenic component and a progestogenic component to a female of childbearing capability in an amount effective to inhibit ovulation, wherein the estrogenic component is selected from the group consisting of substances represented by the following formula (1) in which 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. Another aspect of the invention concerns a pharmaceutical kit comprising oral dosage units that contain the aforementioned estrogenic component and/or a progestogenic component.

Abstract: Disclosed is a method of increasing libido in a woman, said method comprising administering to said woman an effective amount of an estrogenic component selected from the group consisting of: substances represented by the following formula (I) 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; 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 relates to a method of treating infertility in a female mammal that involves controlled ovarian hyperstimulation. The method includes administering to the female a combination of (i) an FSH substance in an amount effective to stimulate follicular development and (ii) a steroid in an effective amount to inhibit or suppress the secretion of luteinising hormone. The steroid can be substances represented by the following 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; no more than 3 of R1, R2, R3, R4 are hydrogen atoms; derivatives of the aforementioned steroid substances; or mixtures of one or more of the aforementioned substances or derivatives.

Abstract: The invention relates to a method of treating an acute vascular disorder in a mammal. The method comprises orally administering to the mammal an effective amount of a steroid. The steroid is selected from the group consisting of: substances represented by formula (I), in which 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; 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 relates to a method of treating or preventing unscheduled bleeding in women, the unscheduled bleeding being the result of repeated administration of a hormonal composition that contains a progestogen, wherein the method includes the administration of an effective amount of Renin Angiotensin System (RAS) suppressor selected from angiotensin converting enzyme inhibitors; angiotensin II receptor antagonists; renin inhibitors and combinations thereof. Other aspects of the invention relate to a pharmaceutical composition containing a RAS suppressor and a progestogen and to a pharmaceutical kit having a plurality of dosage units, wherein at least one dosage unit contains a progestogen; at least one dosage unit contains an estrogen; and at least one dosage unit contains a RAS suppressor.

Abstract: The invention relates to therapeutic and prophylactic treatment of ovarian cancer and metastases thereof. More specifically, the invention relates to immunogenic polypeptides comprising at least a portion of an ovarian tissue cell-associated protein or immunologically active variants thereof and to nucleic acids encoding such polypeptides and to the use thereof in immunotherapeutic methods of treatment. Said immunogenic polypeptides are provided by the zona pellucida (ZP) glycoproteins. ZP glycoproteins and fragments thereof that can induce a CD8+ and/or CD4+ T cell response as well as nucleic acid sequences encoding them can suitably be used in the present immunotherapeutic strategies.

Abstract: The invention is concerned with a method of contraception in a female mammal of childbearing capability. The method has two alternating phases—a preservation phase and a shedding phase—and has at least two sequences of (a) a preservation phase of 3-12 months involving continuous oral administration to the female of dosage units containing: (i) an estrogen selected from 17?-estradiol, esters of 17?-estradiol and combinations thereof, in an amount equivalent to a daily oral dosage of 2.2-5 mg 17?-estradiol, and (ii) a progestogen in an amount equivalent to a daily oral dosage of 30-750 ?g levonorgestrel; and (b) a shedding phase of 4-12 days during which no progestogen is administered. The invention also relates to a contraceptive kit having one or more packaging units that are separately packaged, individually removable oral dosage units for use in the aforementioned contraceptive method.

Abstract: The present invention relates to a method of treating or preventing musculoskeletal pain in a mammal receiving administration of an estrogen. suppressant selected from the group consisting of aromatase inhibitors, GnRH analogues, cyclo-oxy-genase 2 (COX-2) inhibitors, 17?-hydroxysteroid dehydrogenase type 1 inhibitors, progestogens, anti-estrogens and combinations thereof, said method comprising the administration of an effective amount of an estrogenic component, wherein the estrogenic component is selected from the group consisting of: substances represented by the following formula (1) in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alkoxy group with 1-5 carbon 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 is concerned with a kit containing a plurality of hormone units for use in a contraceptive method which consists of two alternating consecutive phases, sometimes referred to as a sequential method or sequential regimen.

Abstract: The present invention relates to a contraceptive method comprising the administration of a hormone composition in an amount effective to inhibit ovulation. More specifically the invention relates to the use of a hormone composition in the manufacture of a kit containing a plurality of dosage units for use in a contraceptive method, which method comprises administering a sequence of said dosage units to a female of childbearing capability so as to provide the hormone composition in an amount which is effective to inhibit ovulation, wherein the hormone composition is dydrogesterone component or a combination of estrogen and dydrogesterone component.

Abstract: One aspect of the invention is concerned with a method of hormone replacement therapy, which method comprises administering to a person in need of such a therapy an effective amount of an estrogenic component selected from the group consisting of: substances represented by the formula (I) in which formula R1, R2, R3, R4 independently are a hydrogen atom, a hydroxyl group or an alokxy 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 thereof; said composition containing virtually no progestogen or anti-progestin. Another aspect of the invention relates to a drug delivery system for enteral or parenteral administration that contains at least 1 &mgr;g of the aforementioned estrogenic component and virtually no progestogen or anti-progestin.

Abstract: The present invention is concerned with a kit containing a plurality of hormone units for use in a contraceptive method which consists of three alternating consecutive phases, sometimes referred to as a sequential method or sequential regimen.

Abstract: A method of contraception in mammalian females, which method comprises the parenteral or rectal administration of an estrogenic component and a progestogenic component to a female of childbearing capability in an amount effective to inhibit ovulation, wherein the estrogenic component is selected from the group consisting of substances represented by the following formula (1) 1

Abstract: Disclosed is a method of increasing libido in a woman, said method comprising administering to said woman an effective amount of an estrogenic component selected from the group consisting of: substances represented by the following formula (I) 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; 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.