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WO 2012/055840 Al (12) INTERNATIONAL APPLICATION PUBLISHED UNDER THE PATENT COOPERATION TREATY (PCT) (19) World Intellectual Property Organization International Bureau (10) International Publication Number (43) International Publication Date _ . _ . 3 May 2012 (03.05.2012) WO 2012/055840 Al (51) International Patent Classification: (81) Designated States (unless otherwise indicated, for every A61K 31/00 (2006.01) A61P 5/30 (2006.01) kind of national protection available): AE, AG, AL, AM, A61K 31/565 (2006.01) A61P 5/34 (2006.01) AO, AT, AU, AZ, BA, BB, BG, BH, BR, BW, BY, BZ, A61K 31/57 (2006.01) A61P 15/00 (2006.01) CA, CH, CL, CN, CO, CR, CU, CZ, DE, DK, DM, DO, A61K 33/30 (2006.01) A61P 15/18 (2006.01) DZ, EC, EE, EG, ES, FI, GB, GD, GE, GH, GM, GT, HN, HR, HU, ID, IL, IN, IS, JP, KE, KG, KM, KN, KP, (21) International Application Number: KR, KZ, LA, LC, LK, LR, LS, LT, LU, LY, MA, MD, PCT/EP201 1/068596 ME, MG, MK, MN, MW, MX, MY, MZ, NA, NG, NI, (22) International Filing Date: NO, NZ, OM, PE, PG, PH, PL, PT, QA, RO, RS, RU, 25 October 201 1 (25.10.201 1) RW, SC, SD, SE, SG, SK, SL, SM, ST, SV, SY, TH, TJ, TM, TN, TR, TT, TZ, UA, UG, US, UZ, VC, VN, ZA, (25) Filing Language: English ZM, ZW. (26) Publication Langi English (84) Designated States (unless otherwise indicated, for every (30) Priority Data: kind of regional protection available): ARIPO (BW, GH, 61/407,570 28 October 2010 (28.10.2010) US GM, KE, LR, LS, MW, MZ, NA, RW, SD, SL, SZ, TZ, UG, ZM, ZW), Eurasian (AM, AZ, BY, KG, KZ, MD, (71) Applicant (for all designated States except US): BAYER RU, TJ, TM), European (AL, AT, BE, BG, CH, CY, CZ, PHARMA AKTIENGESELLSCHAFT [DE/DE]; DE, DK, EE, ES, FI, FR, GB, GR, HR, HU, IE, IS, ΓΓ, Muller Strasse 178, 13353 Berlin (DE). LT, LU, LV, MC, MK, MT, NL, NO, PL, PT, RO, RS, SE, SI, SK, SM, TR), OAPI (BF, BJ, CF, CG, CI, CM, (72) Inventors; and GA, GN, GQ, GW, ML, MR, NE, SN, TD, TG). (75) Inventors/ Applicants (for US only): LEZZAIQ, Samer [LB/US]; 501 9th Street #5 15, Hoboken, New Jersey Published: 07030 (US). SCHNEEWEIS, Axel [DE/DE]; Schreiner- — with international search report (Art. 21(3)) str. 27, 10247 Berlin (DE). PATCHED, Vladimir [DE/DE]; Illtisweg 16, 07749 Jena (DE). (74) Common Representative: BAYER PHARMA AK¬ TIENGESELLSCHAFT; Patents & Licensing, Muller Strasse 178, 13353 Berlin (DE). (54) Title: COMPOSITION AND PREPARATION FOR TREATMENT OF DYSMENORRHEA AND MENSTRUAL PAIN AND USE OF A HORMONAL AGENT AND A ZINC SALT FOR TREATMENT OF MENSTRUAL DISORDERS o 00 © © (57) Abstract: The inventions refers to a pharmaceutical composition and a preparation (regime) containing a hormone and a bio - compatible zinc salt, as well as the use of a zinc salt and a contraceptive active hormone for the treatment of menstrual disorders, Q in particular to alleviate dysmenorrhea. Composition a d preparation for treatment of dysmenorrhea and menstrual pain and use of a hormonal agent and a zinc salt for treatment of menstrual disorders Field of the invention [0001] The present invention is related to a composition and a preparation (regime) for the treatment of dysmenorrhea (or dysmenorrhoea) and menstrual pain, otherwise known as menstrual cramping. A preparation comprising a progestin or an agent having a progestogenic activity and a sufficient amount of zinc to alleviate menstrual disorders, especially dysmenorrhea and menstrual pain. The invention refers furthermore to the use of a progestin and a biocompatible zinc salt for the preparation of a medicament for treatment of menstrual disorders. Background of the invention [0002] Dysmenorrhea (Greek for painful menstruation) is one of the most common gynecological complaints in young women who visit clinicians (Dawood, 2006 4 ; Jamieson and Steege, 1996( ) . [0003] Dysmenorrhea is a medical condition characterized by severe uterine pain during menstruation. While many individuals experience minor pain during menstruation, dysmenorrhea is diagnosed when the pain is so severe as to limit normal activities, or require medication. Most women begin having dysmenorrhea during adolescence, usually within four to five years of the first menstrual period. Painful periods become less common as women age. Dysmenorrhea may coexist with excessively heavy blood loss, known as menorrhagia or heavy menstrual bleeding (HMB). For clinical purposes, dysmenorrhea is divided into two broad categories, primary and secondary (congestive) dysmenorrhea (Dawood, 1985 ( ) . [0004] Primary dysmenorrhea is defined as menstrual pain not associated with macroscopic pelvic pathology. It occurs in the first few years after menarche (Koltz in Lemek et a/., 1992 ) and affects up to 50% of post-pubescent females (Dawood, 1988(¾) . The peak incidence of primary dysmenorrhea occurs in late adolescence and the early 20s (Fraser, 992 18 ) . [0005] In an epidemiological study of an adolescent population (aged 12-17 y, n=2700), Klein and Litt (1981) ( reported a prevalence of dysmenorrhea of 59.7%. Of patients reporting pain, 12% described it as severe; 37%, as moderate; and 49%, as mild. Dysmenorrhea caused 14% of patients to miss school frequently. Although black adolescents reported no increased incidence of dysmenorrhea, they were absent from school more frequently (23.6%) than whites (12.3%), even after adjusting for socioeconomical status. [0006] Similar figures have been reported by Proctor and Farquhar (2006( after Weissman et a!., 2004 ) , reporting that absenteeism from work and school as a result of dysmenorrhea is common (13% to 51% women have been absent at least once and 5% to 14% are often absent owing to the severity of symptoms). [0007] Davis et al. (2005) 2 stress that morbidity, due to dysmenorrhea, represents a substantial public health burden. Based on estimates from the U.S. Census (2000), approximately 2 million adolescents, or 15% of the total females aged 13-19 years, experience severe dysmenorrhea (Davis et al., 2003 after Census 2000 data for the United States). Ylikorkal and Dawood (1978) estimated that dysmenorrhea is the single greatest cause of lost working hours and school absence in adolescent girls. [0008] Primary dysmenorrhea has been associated with alterations in prostaglandin synthesis and metabolism. Investigations of women with primary dysmenorrhea reveal elevated levels of prostaglandin F2a in the endometrium. [0009] Prostaglandins are modified forms of unsaturated fatty acids and function as mediators of a variety of physiological responses such as inflammation, vascular dilation, platelet aggregation and muscle contraction by regulating the tone of smooth muscles. The levels of prostaglandins formed in the lining of the uterus increase as menstruation approaches, with the highest levels at the onset of the menstrual period. An excessive amount of prostaglandins increases uterine contractions causing cramps and pain, also resulting from vasoconstriction, decreased blood perfusion and hypoxia. Generalized effects of prostaglandin excess may account for the headaches, dizziness, hot and cold flashes, diarrhea and nausea that can accompany painful periods. [0010] The role of prostaglandins (PGs) in the pathogenesis of primary dysmenorrhea has been explained by several observations. Prostaglandins, especially prostaglandin F2 (PGF2a) are considered essential factors in the pathogenesis of dysmenorrhea, excess menstrual bleeding and associated pelvic pain (Rosenwaks , Seegar-Jones 2 (2003) in Wright et al. Accordingly, suppression of prostaglandin production or diminution of the uterus liability to their action represent efficient therapeutic approaches to dysmenorrhea and heavy menstrual bleeding (Lethaby et al. (2007) (2¾ . [0011] Prostaglandin synthesis and metabolism in the uterus is controlled by 2 2 progesterone (Rebsamen et a/.,2004)< ; Young M and Funder J (2003)< ; Zhang Z et al. (2002) 2 . Deficient progesterone secretion (e.g. as a result of anovulation or corpus luteum insufficiency in adolescents), and the resulting increase in prostaglandin production, causally contribute to painful menstruation and increased menstrual blood loss. Although progestin treatment (e.g. in the form of oral contraceptives) is a proven therapeutic option, abrupt treatment cessation (e.g. hormone-free pause of oral contraceptive administration) can rapidly evoke increased prostaglandin production and sensitivity in the uterus and recurrence of painful pelvic sensation and increased blood loss. [001 2] The clinical symptoms of primary dysmenorrhea are similar to those induced by the administration of prostaglandins (PGF-2ct and PGE2) for the induction of labour. The increased production of prostaglandins by the endometrium during the luteal and menstrual phases of ovulatory cycles is consistent with the occurrence of primary dysmenorrhea mainly in ovulatory cycles. The concentrations of prostaglandins in the endometrium and menstrual fluid of dysmenorrheic women are significantly higher than in controls [Dawood (2006) after Pickles (1957) and Pickles et al. (1963)]<1 >and certain prostaglandin inhibitors are useful in the treatment of dysmenorrhea. The change in prostaglandin production can explain the major symptoms of primary dysmenorrhea, including the increased uterine contractility, uterine ischemia and the lowering of the pain threshold to chemical and physical stimuli in the pelvic nerve terminals. Since ovulation is a prerequisite for primary dysmenorrhea, ovarian steroid hormones are likely to be involved in regulating the intrauterine production of prostaglandins at menstruation. It has been suggested
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