Nestorone®/Estradiol Transdermal Gel
Nestragel
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Transdermal
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Intended Duration:
- Short-Acting
- Development Stage: Phase II
- Developer(s)/researcher(s): Population Council, Antares Pharma
Details
- API: Nestorone®, Estradiol
- Target: Progesterone Receptor, Estrogen Receptor
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Mechanism of Action:
- Ovulation Inhibition
- Cervical Mucus Changes
- Endometrial Changes
- Regimen: 1 Application/Day
- MPT: Not Potential MPT
- Promising Attributes: Clinical evaluation determined that product was well-tolerated and effective
Product Status
While product advanced to late-stage clinical evaluation, it has been removed from the developer website and there is no indication of development following the approval of the product patent in 2017.
History
2000: Nesterone is synthesized, with its potential for transdermal absorption confirmed shortly after
2008: Population Council submits an IND application for a NES/E2 female contraceptive gel
2010: Phase II study results suggest that the product is safe, effective, and acceptable
2015: Additional Phase II study results confirm lowest effective dose
2017: Population Council is granted a patent on the concept