Nestragel�
Alternative Name: Nestorone (NES) + Estradiol (E2) Transdermal Gel
Description: Proprietary gel technology (Antares ATD? technology) of a hydroalcoholic gel combined with permeation enhancers to deliver Nestorone and Estradiol through the skin. The gel is administered by an airless, pre-filled metered dose pump dispenser.
Product Details
User: Female
Hormonal: Yes
Delivery Method: Transdermal
Duration Type: Short-acting
Duration: One day
Regimen: - daily
- daily
Dose: Nestorone 3mg/day; E2 1mg/day per daily dose; 10% absorbed
Active Pharmaceutical Ingredient (API): - nestorone
- estradiol
- nestorone
- estradiol
Multipurpose Preventive Technology (MPT): No
Status Details
Developer: Antares, Population Council
Project Phase: Pre-Clinical and Clinical Development
Development Stage: Phase II
Active Development: Yes
Status Details: - Phase 1 and 2 clinical trials have been conducted in Chile, the Dominican Republic, and the USA. An Investigational New Drug (IND) application was submitted to the FDA in 2008, and outcomes from the dose-finding study were used to support registration of a new patent.
- Phase 1 and 2 clinical trials have been conducted in Chile, the Dominican Republic, and the USA. An Investigational New Drug (IND) application was submitted to the FDA in 2008, and outcomes from the dose-finding study were used to support registration of a new patent.
Additional Information
References: Population Council website: www.popcouncil.org/research/nestorone-estradiol-transdermal-gel-contrace...
Population Council website: www.popcouncil.org/research/nestorone-estradiol-transdermal-gel-contrace...