NICHD: R&D: SUPPORTING THE PHASE IIB CLINICAL TRIAL OF SUBCUTANEOUS LEVONORGESTREL BUTANOATE (LB) FOR FEMALE CONTRACEPTION: NON-SEVERABLE

Health Decisions, Inc., Durham NC

Investigators

Abstract

The Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), through its Contraceptive Development Program (CDP), is conducting a Phase IIb clinical trial to evaluate the safety, efficacy, and acceptability of a novel long-acting injectable formulation of Levonorgestrel Butanoate (LB) for female contraception. This multicenter, open-label trial will be executed through the Contraceptive Clinical Trials Network (CCTN), leveraging six experienced clinical sites and coordinated by the Statistical and Clinical Coordinating Center (SCCC). The SCCC provides the infrastructure and expertise to ensure rigorous clinical data collection, quality assurance, compliance with regulatory requirements, and statistical oversight from study design through final reporting. Scope of Work: The Contractor shall independently provide full-service clinical coordination, statistical and data management support, and regulatory tracking throughout all phases (A-D) of the LB Phase IIb trial. This includes, but is not limited to, protocol development assistance, site monitoring, data system setup and oversight, safety tracking, and clinical study reporting.