Spots Global Cancer Trial Database for Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
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Trial Identification
Brief Title: Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids
Official Title: A Phase 3, Multicentre, Randomized, Double-blind, Placebo-controlled Study Investigating the Efficacy and Safety of Daily Oral Administration of OBE2109 Alone and in Combination With Add-back Therapy for the Management of Heavy Menstrual Bleeding Associated With Uterine Fibroids in Premenopausal Women
Study ID: NCT03070951
Study Description
Brief Summary: The primary objective of this study is to demonstrate the superior efficacy versus placebo of OBE2109 alone and in combination with add-back therapy for the reduction of heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
Detailed Description: The study is a prospective, randomized, parallel group, double-blind, placebo-controlled phase 3 study investigating the efficacy and safety of OBE2109 alone and in combination with add-back therapy for the treatment of uterine fibroids. Subjects will be randomized to one of 5 treatment groups in a 1:1:1:1:1 ratio.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Site reference ID 905, Chino, California, United States
Site reference ID 918, Huntington Park, California, United States
Site reference ID 902, San Diego, California, United States
Site reference ID 903, Denver, Colorado, United States
Site reference ID 913, Bradenton, Florida, United States
Site reference ID 912, Orlando, Florida, United States
Site reference ID 915, Augusta, Georgia, United States
Site reference ID 924, Nampa, Idaho, United States
Site reference ID 926, Covington, Louisiana, United States
Site reference ID 927, Metairie, Louisiana, United States
Site reference ID 900, Metairie, Louisiana, United States
Site reference ID 901, Canton, Michigan, United States
Site reference ID 932, Detroit, Michigan, United States
Site reference ID 916, Jefferson City, Missouri, United States
Site reference ID 930, Albuquerque, New Mexico, United States
Site reference ID 933, West Seneca, New York, United States
Site reference ID 931, Hamlet, North Carolina, United States
Site reference ID 914, Westerville, Ohio, United States
Site reference ID 928, Erie, Pennsylvania, United States
Site reference ID 919, West Columbia, South Carolina, United States
Site reference ID 907, Houston, Texas, United States
Site reference ID 911, Salt Lake City, Utah, United States
Site reference ID 917, Madison, Wisconsin, United States
Site reference ID 265, Gabrovo, , Bulgaria
Site reference ID 255, Pleven, , Bulgaria
Site reference ID 258, Plovdiv, , Bulgaria
Site reference ID 266, Sliven, , Bulgaria
Site reference ID 264, Smolyan, , Bulgaria
Site reference ID 251, Sofia, , Bulgaria
Site reference ID 252, Sofia, , Bulgaria
Site reference ID 254, Sofia, , Bulgaria
Site reference ID 256, Sofia, , Bulgaria
Site reference ID 257, Sofia, , Bulgaria
Site reference ID 267, Sofia, , Bulgaria
Site reference ID 281, Praha, , Czechia
Site reference ID 286, Praha, , Czechia
Site reference ID 287, Praha, , Czechia
Site reference ID 288, Praha, , Czechia
Site reference ID 283, Písek, , Czechia
Site reference ID 284, Příbram, , Czechia
Site reference ID 289, Tábor, , Czechia
Site reference ID 282, Vsetín, , Czechia
Site reference ID 285, České Budějovice, , Czechia
Site reference ID 315, Baja, , Hungary
Site reference ID 303, Budapest, , Hungary
Site reference ID 307, Budapest, , Hungary
Site reference ID 301, Debrecen, , Hungary
Site reference ID 308, Debrecen, , Hungary
Site reference ID 313, Debrecen, , Hungary
Site reference ID 314, Kecskemét, , Hungary
Site reference ID 304, Kistarcsa, , Hungary
Site reference ID 306, Nyíregyháza, , Hungary
Site reference ID 451, Riga, , Latvia
Site reference ID 452, Riga, , Latvia
Site reference ID 454, Riga, , Latvia
Site reference ID 463, Kaunas, , Lithuania
Site reference ID 460, Vilnius, , Lithuania
Site reference ID 461, Vilnius, , Lithuania
Site reference ID 464, Vilnius, , Lithuania
Site reference ID 502, Białystok, , Poland
Site reference ID 504, Katowice, , Poland
Site reference ID 509, Katowice, , Poland
Site reference ID 513, Katowice, , Poland
Site reference ID 514, Katowice, , Poland
Site reference ID 501, Knurów, , Poland
Site reference ID 506, Lublin, , Poland
Site reference ID 508, Lublin, , Poland
Site reference ID 511, Lublin, , Poland
Site reference ID 519, Piaseczno, , Poland
Site reference ID 518, Poznań, , Poland
Site reference ID 505, Przemyśl, , Poland
Site reference ID 503, Szczecin, , Poland
Site reference ID 507, Warsaw, , Poland
Site reference ID 510, Łódź, , Poland
Site reference ID 517, Łódź, , Poland
Site reference ID 512, Świdnik, , Poland
Site reference ID 606, Braşov, , Romania
Site reference ID 601, Bucuresti, , Romania
Site reference ID 603, Bucuresti, , Romania
Site reference ID 604, Bucuresti, , Romania
Site reference ID 605, Târgu-Mureş, , Romania
Site reference ID 813, Chernivtsi, , Ukraine
Site reference ID 801, Ivano-Frankivs'k, , Ukraine
Site reference ID 814, Kharkiv, , Ukraine
Site reference ID 802, Kyiv, , Ukraine
Site reference ID 803, Kyiv, , Ukraine
Site reference ID 805, Kyiv, , Ukraine
Site reference ID 806, Kyiv, , Ukraine
Site reference ID 807, Kyiv, , Ukraine
Site reference ID 804, L'viv, , Ukraine
Site reference ID 811, Odesa, , Ukraine
Site reference ID 808, Ternopil', , Ukraine
Site reference ID 817, Vinnytsia, , Ukraine
Site reference ID 812, Zaporizhzhya, , Ukraine
Site reference ID 815, Zaporizhzhya, , Ukraine
Site reference ID 816, Zaporizhzhya, , Ukraine
Contact Details
Name: ObsEva SA
Affiliation: Geneva
Role: STUDY_DIRECTOR
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