Despite the popularity of injectable contraceptives, discontinuation rates can be high due to side effects and user difficulty in complying with reinjection schedules. The most common injectable contraceptive is depot-medroxyprogesterone acetate (DMPA), which requires women to return to their provider monthly or quarterly. As an alternative, researchers are developing longer-acting injectables that use levonorgestrel (LNG), which has been extensively studied in other contraceptive products.
FHI 360 is developing a six-month LNG self-injectable contraceptive, referred to as the LNG long-acting microsphere injectable, or the LLMI. Funded by the Bill & Melinda Gates Foundation, this work builds on foundational research conducted through the Contraceptive Technology Innovation (CTI) Initiative.
In collaboration with the Shanghai Institute of Planned Parenthood Research, FHI 360 is bringing this product through the preclinical development stage and into a first-in-human or Phase 1 clinical trial.
Activities under this grant include:
- Animal studies to evaluate LNG formulation
- First-in-human/Phase 1 clinical study to investigate safety and pharmacokinetics of the LLMI
- Formulation and manufacturing process optimization for the LLMI to support later stages of clinical development
This project is an important step in the development of a product that offers a unique set of attributes, including self-injection, longer duration of use and a potentially improved side-effect profile.