On Demand Oral Levonorgestrel
- User: Female
- Hormonal: Hormonal
-
Delivery type:
- Oral
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Intended Duration:
- Pericoital
- Development Stage: Pre-Clinical
- Developer(s)/researcher(s): FHI 360, HRA Pharma, Gynuity Health Projects, Population Council, PATH
Details
- API: Levonorgestrel
- Target: Progesterone Receptor
-
Mechanism of Action:
- Ovulation Delay
- Cervical Mucus Changes
- Regimen: On Demand
- MPT: Not Potential MPT
- Promising Attributes: LNG 1.5mg is widely approved as an emergency contraceptive, and study of its use as an on-demand method has been active for more than a decade. It may be a safe option for users who do not want to use a hormonal method taken at a regular interval.
Product Status
Active Pre-Clinical Development & Recent Feasibility/Acceptability Evaluation
History
Post-coital LNG was first approved as an emergency contraception in 1999, and has been evaluated for pericoital non-emergency use in a number of studies. A 2011 review identified at least 15 publications focused on pericoital LNG use. But all studies were old and of suboptimal quality; the reviewers concluded that a more rigorous research was needed. FHI 360 led a 2013 study that was discontinued early due to slow enrollment - results could not prove that 0.75 mg LNG when used pericoitally was more effective than condoms. The WHO led a 2016 Ph III multi-center study that found that with a higher dose of LNG (1.5 mg) for pericoital use, the method was reasonably effective and acceptable, and recommended further research. Socio-behavioral research indicates strong user interest in the potential method, and feasibility/acceptability research conducted by Camber Collective and PSI Population Council suggests potential demand and health system readiness. FHI 360 is pursuing additional development.