Levonorgestrel Butanoate Injectable
- User: Female
- Hormonal: Hormonal
-
Delivery type:
- Injectable
-
Intended Duration:
- Short-Acting
- Development Stage: Phase II
- Developer(s)/researcher(s): WHO HRP, CONRAD, NICHD, Oregon Health & Science University, Health Decisions
Details
- API: Levonorgestrel Butanoate
- Target: Progesterone Receptor
-
Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Inactive Materials: Not Yet Determined
- Regimen: 1 Injection/4 Months
- MPT: Not Potential MPT
- Promising Attributes: In comparison to MPA-based injectable products, LB-based injectables may have a more desirable side effect profile and more rapid return to fertility.
Product Status
Active Clinical Research
History
1983: LNG Butanoate is formulated and evaluated in vivo & in vitro by WHO chemical synthesis programme
1991: Phase I studies suggest LB viability as a female contraceptive method
2017: OHSU, NICHD, and CONRAD publish results of Phase I pilot study, which indicates that LB does not reliably suppress ovulation for 90 days.
2020: NIH launches Ph I trial with new formulation, intended to conclude in 2026
2024: NICHD files a patent for LB formulations and contraceptive methods
2025: NIH registers Ph IIb trial for subcutaneous LB injections administered at a 4-month interval in 165 female participants, intended to evaluate contraceptive efficacy, safety, and user acceptability. The trial will initiate in 2026, with its primary completion in 2028 and its full completion in 2029.