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: NCT03070899
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 192, Birmingham, Alabama, United States
Site reference ID 169, Dothan, Alabama, United States
Site reference ID 353, Mobile, Alabama, United States
Site reference ID 232, Vestavia Hills, Alabama, United States
Site reference ID 242, Phoenix, Arizona, United States
Site reference ID 355, Tucson, Arizona, United States
Site reference ID 211, Arcadia, California, United States
Site reference ID 184, Cerritos, California, United States
Site reference ID 147, Escondido, California, United States
Site reference ID 154, Huntington Park, California, United States
Site reference ID 185, Los Angeles, California, United States
Site reference ID 199, Northridge, California, United States
Site reference ID 111, Panorama City, California, United States
Site reference ID 166, Sacramento, California, United States
Site reference ID 101, San Diego, California, United States
Site reference ID 239, Upland, California, United States
Site reference ID 112, Westminster, California, United States
Site reference ID 144, Denver, Colorado, United States
Site reference ID 246, Englewood, Colorado, United States
Site reference ID 234, Thornton, Colorado, United States
Site reference ID 189, New Haven, Connecticut, United States
Site reference ID 105, Washington, District of Columbia, United States
Site reference ID 231, Boca Raton, Florida, United States
Site reference ID 190, Boca Raton, Florida, United States
Site reference ID 168, Clearwater, Florida, United States
Site reference ID 233, DeLand, Florida, United States
Site reference ID 197, Fort Lauderdale, Florida, United States
Site reference ID 135, Hialeah, Florida, United States
Site reference ID 146, Hialeah, Florida, United States
Site reference ID 191, Jacksonville, Florida, United States
Site reference ID 204, Loxahatchee Groves, Florida, United States
Site reference ID 117, Miami Lakes, Florida, United States
Site reference ID 134, Miami Lakes, Florida, United States
Site reference ID 129, Miami Springs, Florida, United States
Site reference ID 137, Miami, Florida, United States
Site reference ID 142, Miami, Florida, United States
Site reference ID 110, Miami, Florida, United States
Site reference ID 106, Miami, Florida, United States
Site reference ID 127, Miami, Florida, United States
Site reference ID 107, Miramar, Florida, United States
Site reference ID 124, New Port Richey, Florida, United States
Site reference ID 141, Orlando, Florida, United States
Site reference ID 140, Orlando, Florida, United States
Site reference ID 207, Saint Petersburg, Florida, United States
Site reference ID 113, Tampa, Florida, United States
Site reference ID 163, Columbus, Georgia, United States
Site reference ID 158, Norcross, Georgia, United States
Site reference ID 151, Norcross, Georgia, United States
Site reference ID 150, Sandy Springs, Georgia, United States
Site reference ID 359, Idaho Falls, Idaho, United States
Site reference ID 352, Meridian, Idaho, United States
Site reference ID 174, Champaign, Illinois, United States
Site reference ID 182, Oak Brook, Illinois, United States
Site reference ID 178, Shawnee Mission, Kansas, United States
Site reference ID 354, Wichita, Kansas, United States
Site reference ID 176, Lake Charles, Louisiana, United States
Site reference ID 109, Marrero, Louisiana, United States
Site reference ID 248, Frederick, Maryland, United States
Site reference ID 226, Silver Spring, Maryland, United States
Site reference ID 228, Towson, Maryland, United States
Site reference ID 149, Fall River, Massachusetts, United States
Site reference ID 126, Fall River, Massachusetts, United States
Site reference ID 100, Bay City, Michigan, United States
Site reference ID 145, Detroit, Michigan, United States
Site reference ID 214, Saginaw, Michigan, United States
Site reference ID 170, Saginaw, Michigan, United States
Site reference ID 138, Missoula, Montana, United States
Site reference ID 236, Las Vegas, Nevada, United States
Site reference ID 245, Lawrenceville, New Jersey, United States
Site reference ID 175, Brooklyn, New York, United States
Site reference ID 188, New York, New York, United States
Site reference ID 208, Port Jefferson, New York, United States
Site reference ID 133, Staten Island, New York, United States
Site reference ID 104, Greensboro, North Carolina, United States
Site reference ID 131, Morehead City, North Carolina, United States
Site reference ID 102, Raleigh, North Carolina, United States
Site reference ID 187, Southern Pines, North Carolina, United States
Site reference ID 119, Winston-Salem, North Carolina, United States
Site reference ID 186, Cincinnati, Ohio, United States
Site reference ID 164, Cleveland, Ohio, United States
Site reference ID 230, Fairfield, Ohio, United States
Site reference ID 213, Franklin, Ohio, United States
Site reference ID 116, Bryn Mawr, Pennsylvania, United States
Site reference ID 195, Hershey, Pennsylvania, United States
Site reference ID 222, Indiana, Pennsylvania, United States
Site reference ID 165, Jenkintown, Pennsylvania, United States
Site reference ID 210, Pittsburgh, Pennsylvania, United States
Site reference ID 148, Smithfield, Pennsylvania, United States
Site reference ID 351, North Charleston, South Carolina, United States
Site reference ID 358, Spartanburg, South Carolina, United States
Site reference ID 159, Chattanooga, Tennessee, United States
Site reference ID 235, Knoxville, Tennessee, United States
Site reference ID 205, Memphis, Tennessee, United States
Site reference ID 180, Memphis, Tennessee, United States
Site reference ID 238, Austin, Texas, United States
Site reference ID 155, Austin, Texas, United States
Site reference ID 201, Beaumont, Texas, United States
Site reference ID 247, Corpus Christi, Texas, United States
Site reference ID 183, Dallas, Texas, United States
Site reference ID 216, Dallas, Texas, United States
Site reference ID 200, Dallas, Texas, United States
Site reference ID 250, Fort Worth, Texas, United States
Site reference ID 244, Fort Worth, Texas, United States
Site reference ID 115, Frisco, Texas, United States
Site reference ID 157, Houston, Texas, United States
Site reference ID 120, Houston, Texas, United States
Site reference ID 219, Houston, Texas, United States
Site reference ID 217, Houston, Texas, United States
Site reference ID 218, Pasadena, Texas, United States
Site reference ID 172, San Antonio, Texas, United States
Site reference ID 128, Webster, Texas, United States
Site reference ID 125, West Jordan, Utah, United States
Site reference ID 103, Norfolk, Virginia, United States
Site reference ID 171, Norfolk, Virginia, United States
Site reference ID 123, Richmond, Virginia, United States
Site reference ID 237, Bellevue, Washington, United States
Contact Details
Name: ObsEva SA
Affiliation: Geneva
Role: STUDY_DIRECTOR
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