CCTN LB PHASE 2B CLINICAL TRIAL

University Of Colorado, Boulder CO

Investigators

Abstract

This acquisition is to continue CPD’s development of LB to address FDA regulatory requirements and transition to approval for a Phase 3 study. This study will be separated into 4 separate phases, with distinct aims and deliverables. The Government estimates the Contractor(s) to complete protocol finalization, regulatory approvals, start-up, and commencement of initial recruitment and enrollment in Phase A, optimization and continuation of recruitment, screening, and enrollment and initiation of follow-up of enrolled subjects, and finalization of regulatory requirements in Phase B, completion of follow-up and monitoring of active subjects, clinical follow-up, and data collection for all enrolled participants in Phase C, and exit, site close-out, completion of study reports and clinical summary report in Phase D. The estimated time for each Phase is outlined in the Technical Requirements below. The Scope is to evaluate in obese and non-obese women the pharmacokinetics (PK), pharmacodynamic (PD) effects, safety, and contraceptive efficacy of levonorgestrel butanoate (LB) formulated as a long acting injectable. The Objective is to obtain valid and reliable data to determine the effects, duration of action, PK and PD, contraceptive efficacy, and safety of long-acting formulations of LB for use in obese and nonobese women of reproductive age.