NICHD: R&D: A PHASE 2B STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SUBCUTANEOUS LEVONORGESTREL BUTANOATE FOR FEMALE CONTRACEPTION: SEVERABLE

University Of California At Davis, Davis CA

Investigators

Abstract

The NICHD serves as the lead federal agency advancing research in fertility optimization. Within NICHD, the Contraceptive Development Program (CDP) under the Division of Population Health Research (DiPHR) is tasked with developing novel contraceptive methods for both men and women. Clinical evaluation of these novel contraceptive products is conducted through CDP’s Contraceptive Clinical Trials Network (CCTN), a group of clinical sites prequalified on the basis of experienced personnel and facilities using a full and open competitive IDIQ contract mechanism. The CCTN rigorously assesses the safety, efficacy, and tolerability of candidate drugs and devices across all phases of development—from first-in-human trials to Phase III. Building on its mandate to advance fertility optimization and contraceptive innovation, NICHD’s Contraceptive Development Program (CDP) is supporting the clinical development of levonorgestrel butanoate (LB), a long-acting, progestin-only injectable contraceptive. This effort addresses a critical public health need: most currently available combined hormonal contraceptives are associated with an increased risk of venous thromboembolism (VTE), making them unsuitable or less desirable for many women—particularly those who are obese or have other risk factors. Consequently, there is a pressing need for estrogen-free, safe, and effective alternatives that provide long-term contraception without increasing thrombotic risk. The objective for 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.