136
Participants
Start Date
March 3, 2020
Primary Completion Date
September 30, 2024
Study Completion Date
September 30, 2024
levonorgestrel butanoate (LB) injection
"The initial formulation of the investigational product (IP) is LB Injectable Suspension at a concentration of 40 mg/2 mL (20 mg/mL). Each vial contains 2 mL at 20mg/mL for a total of 40 mg. This formulation will only be used for dosing groups A and B with the injections completed as 40 mg IM (2 mL) or 40 mg SQ (2 mL).~The second formulation of the investigational product (IP) is LB Injectable Suspension is a concentration of 140 mg/2 mL (70 mg/mL). Each vial contains 2 mL at 70 mg/mL for a total of 140 mg. This formulation will only be used for dosing groups B2, C, and D with the injections completed as 40 mg SQ (0.57 mL), 50 mg SQ (0.71 mL), and 60 mg SQ (0.86 mL)."
RECRUITING
Columbia University, New York
RECRUITING
Eastern Virginia Medical School, Norfolk
RECRUITING
Comprehensive Women's Health Center, Denver
RECRUITING
University of Utah, Salt Lake City
RECRUITING
University of California, Davis, Davis
RECRUITING
Oregon Health and Science University, Portland
RECRUITING
Boston Medical Center Corporation, Boston
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Premier Research
OTHER