Dapivirine + Levonorgestrel Intravaginal Ring
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Vaginal Ring
-
Intended Duration:
- Short-Acting
- Development Stage: Phase I
- Developer(s)/researcher(s): International Partnership for Microbicides/Population Council, Microbicide Trials Network and the Contraceptive Clinical Trials Network, NIH
Details
- API: Dapivirine, Levonorgestrel
- Target: Progesterone Receptor
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Mechanism of Action:
- Inhibition of Sperm Capacitation
- Inhibition of Sperm Motility
- Cervical Mucus Changes
- Ovulation Inhibition
- Endometrial Changes
- Anti-Microbial
- Inactive Materials: Silicone
- Regimen: 1 Insertion/90 Days
- MPT: Potential MPT
- Promising Attributes: MPTs are appealing to users who may be at risk HIV and are interested in preventing pregnancies. DPV & LNG are both widely evaluated and used in a number of approved products. Vaginal rings are also user controlled, reversible, and minimally invasive.
Product Status
Developer Website Indicates Phase Ib Trial Ongoing as of Nov. 2024
History
2016-2021: Preclinical development & formulation research for DPV+LNG based MPT, led by International Partnership for Microbicides with multi-donor support
2022: International Partnership for Microbicides acquired by Population Council, which opts to continue development following the successful development of a one-month Dapivirine ring for HIV prevention
2023: Phase I trial qualitative results published, focused on user feedback on product design
2024: Results from two Phase I trials published, showing high tolerability, LNG concentrations comparable to those of approved LNG-releasing contraceptives, and DPV concentrations above those of previous DPV ring studies
2025: Population Council publishes acceptability data from the Phase I trials, indicating a need to improve issues relating to vaginal bleeding and expulsion to enhance acceptability.