A Study to Evaluate the PK and PD of IM or SQ Injections of Levonorgestrel Butanoate (LB) for Female Contraception

PHASE1UnknownINTERVENTIONAL
Enrollment

136

Participants

Timeline

Start Date

March 3, 2020

Primary Completion Date

September 30, 2024

Study Completion Date

September 30, 2024

Conditions
Healthy WomenFemale Contraception
Interventions
BIOLOGICAL

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)."

Trial Locations (7)

10032

RECRUITING

Columbia University, New York

23507

RECRUITING

Eastern Virginia Medical School, Norfolk

80230

RECRUITING

Comprehensive Women's Health Center, Denver

84132

RECRUITING

University of Utah, Salt Lake City

95817

RECRUITING

University of California, Davis, Davis

97239

RECRUITING

Oregon Health and Science University, Portland

02118

RECRUITING

Boston Medical Center Corporation, Boston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Premier Research

OTHER