Nitinol Frame Levonorgestrel-Releasing IUD
LevoCept
- User: Female
- Hormonal: Hormonal
-
Delivery type:
- Intrauterine
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Intended Duration:
- Long-Acting
- Development Stage: Phase III
- Developer(s)/researcher(s): Sebela Pharmaceuticals
Details
- API: Levonorgestrel
- Target: Progesterone Receptor
-
Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Inactive Materials: Nitinol
- Regimen: 1 Insertion/3-5 Years
- MPT: Not Potential MPT
- Promising Attributes: Nitinol frame is intended to conform to different uterine shapes and sizes, while maintaining the contraceptive efficacy and duration of existing LNG-based IUDs.
Product Status
Public intention to initiate Phase III trial in 2026
History
2016: Sebela Women's Health initiates Phase II safety and efficacy trial, NCT02882191
2024: Sebela publicly indicates intent to initiate Phase III multi-center trial, NCT04457076, in 2026.