Miudella®
VeraCept, Copper and Nitinol Intrauterine Device
- User: Female
- Hormonal: Non-Hormonal
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Delivery type:
- Intrauterine
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Intended Duration:
- Long-Acting
- Development Stage: Single-Country Approval
- Developer(s)/researcher(s): ContraMed, LLC, Sebela Women's Health
Details
- API: Copper
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Mechanism of Action:
- Cervical Mucus Changes
- Inhibition of Sperm Motility
- Inhibition of Sperm Capacitation
- Inactive Materials: Nitinol (Nickel and Titanium Composite Material) Wire
- Regimen: 1 Insertion/3 Years
- MPT: Not Potential MPT
- Promising Attributes: Clinical trial results indicate that Miudella's unique frame design allows the device to use less copper without reducing efficacy, which may reduce pain and bleeding.
Product Status
Approved by US FDA in February 2025
History
2015: First clinical results published, indicating that the device may result in lower pain at insertion, fewer expulsions, and higher continuation than traditional copper IUDs
2020: Ph II results at 36 months show high efficacy and product safety
2023: Sebela Women's Health announces positive primary completion results from an ongoing Phase III trial of the product
2025: Sebela Women's Health announces US FDA Approval of product, now named Miudella®