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

Dose: Nestorone 3mg/day; E2 1mg/day per daily dose; 10% absorbed

Active Pharmaceutical Ingredient (API):
  • 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.

Additional Information

References:

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