208
Participants
Start Date
June 30, 2013
Primary Completion Date
September 30, 2014
Study Completion Date
October 31, 2014
TV-1380 150 mg
Subjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents).
TV-1380 300 mg
Subjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380.
Placebo
Subjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo.
Teva Investigational Site 10663, Los Angeles
Teva Investigational Site 10665, Oceanside
Teva Investigational Site 10659, San Francisco
Teva Investigational Site 10746, Torrance
Teva Investigational Site 10664, North Miami
Teva Investigational Site 10661, Boston
Teva Investigational Site 10668, New Bedford
Teva Investigational Site 10747, St Louis
Teva Investigational Site 10745, Las Vagas
Teva Investigational Site 10667, Marlton
Teva Investigational Site 10662, Columbus
Teva Investigational Site 10660, Pittsburgh
Teva Investigational Site 10658, Charleston
Teva Investigational Site 10666, Salt Lake City
Teva Investigational Site 31064, Alicante
Teva Investigational Site 31063, Barcelona
Teva Investigational Site 31065, Barcelona
Teva Investigational Site 31069, Barcelona
Teva Investigational Site 31068, Madrid
Teva Branded Pharmaceutical Products R&D, Inc.
INDUSTRY