Efficacy and Safety of OBE2109 in Subjects With Heavy Menstrual Bleeding Associated With Uterine Fibroids

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

May 23, 2017

Primary Completion Date

September 16, 2019

Study Completion Date

October 4, 2020

Conditions
Uterine FibroidsHeavy Menstrual Bleeding
Interventions
DRUG

OBE2109

OBE2109 100mg tablets for oral administration once daily

DRUG

Placebo to match OBE2109

Placebo to match OBE2109 100mg tablets for oral administration once daily

DRUG

Placebo to match Add-back

Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

DRUG

Add-back

Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily

Trial Locations (96)

14224

Site reference ID 933, West Seneca

16507

Site reference ID 928, Erie

28345

Site reference ID 931, Hamlet

29572

Site reference ID 918, Huntington Park

30912

Site reference ID 915, Augusta

32806

Site reference ID 912, Orlando

34209

Site reference ID 913, Bradenton

37203

Site reference ID 919, West Columbia

43081

Site reference ID 914, Westerville

48187

Site reference ID 901, Canton

48201

Site reference ID 932, Detroit

53717

Site reference ID 917, Madison

65109

Site reference ID 916, Jefferson City

70006

Site reference ID 927, Metairie

70433

Site reference ID 926, Covington

77058

Site reference ID 907, Houston

80209

Site reference ID 903, Denver

83687

Site reference ID 924, Nampa

84124

Site reference ID 911, Salt Lake City

87102

Site reference ID 930, Albuquerque

91710

Site reference ID 905, Chino

92123

Site reference ID 902, San Diego

Site reference ID 900, Metairie

Unknown

Site reference ID 265, Gabrovo

Site reference ID 255, Pleven

Site reference ID 258, Plovdiv

Site reference ID 266, Sliven

Site reference ID 264, Smolyan

Site reference ID 251, Sofia

Site reference ID 252, Sofia

Site reference ID 254, Sofia

Site reference ID 256, Sofia

Site reference ID 257, Sofia

Site reference ID 267, Sofia

Site reference ID 285, České Budějovice

Site reference ID 283, Písek

Site reference ID 281, Prague

Site reference ID 286, Prague

Site reference ID 287, Prague

Site reference ID 288, Prague

Site reference ID 284, Příbram

Site reference ID 289, Tábor

Site reference ID 282, Vsetín

Site reference ID 315, Baja

Site reference ID 303, Budapest

Site reference ID 307, Budapest

Site reference ID 301, Debrecen

Site reference ID 308, Debrecen

Site reference ID 313, Debrecen

Site reference ID 314, Kecskemét

Site reference ID 304, Kistarcsa

Site reference ID 306, Nyíregyháza

Site reference ID 451, Riga

Site reference ID 452, Riga

Site reference ID 454, Riga

Site reference ID 463, Kaunas

Site reference ID 460, Vilnius

Site reference ID 461, Vilnius

Site reference ID 464, Vilnius

Site reference ID 502, Bialystok

Site reference ID 504, Katowice

Site reference ID 509, Katowice

Site reference ID 513, Katowice

Site reference ID 514, Katowice

Site reference ID 501, Knurów

Site reference ID 510, Lodz

Site reference ID 517, Lodz

Site reference ID 506, Lublin

Site reference ID 508, Lublin

Site reference ID 511, Lublin

Site reference ID 519, Piaseczno

Site reference ID 518, Poznan

Site reference ID 505, Przemyśl

Site reference ID 503, Szczecin

Site reference ID 512, Świdnik

Site reference ID 507, Warsaw

Site reference ID 606, Brasov

Site reference ID 601, Bucharest

Site reference ID 603, Bucharest

Site reference ID 604, Bucharest

Site reference ID 605, Târgu Mureş

Site reference ID 813, Chernivtsi

Site reference ID 801, Ivano-Frankivsk

Site reference ID 814, Kharkiv

Site reference ID 802, Kyiv

Site reference ID 803, Kyiv

Site reference ID 805, Kyiv

Site reference ID 806, Kyiv

Site reference ID 807, Kyiv

Site reference ID 804, Lviv

Site reference ID 811, Odesa

Site reference ID 808, Ternopil

Site reference ID 817, Vinnytsia

Site reference ID 812, Zaporizhzhya

Site reference ID 815, Zaporizhzhya

Site reference ID 816, Zaporizhzhya

Sponsors

Lead Sponsor

All Listed Sponsors
lead

ObsEva SA

INDUSTRY