Vaginal inserted estradiol pharmaceutical compositions and methods

  • US 10,258,630 B2
  • Filed: 02/09/2018
  • Issued: 04/16/2019
  • Est. Priority Date: 10/22/2014
  • Status: Active Grant
First Claim
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1. A method for treating moderate to severe dyspareunia in a subject, the method comprising:

  • intravaginally administering to the subject a dosage form comprising a liquid pharmaceutical composition, wherein the viscosity of the composition ranges from about 50 cP to about 1000 cP at 25°

    C., wherein the dosage form is manually inserted into the vagina, wherein the composition comprises estrogen as the only active agent, wherein all of the estradiol is encapsulated in the capsule, wherein the composition comprises about 4 μ

    g to about 25 μ

    g of estradiol, wherein the administration comprises inserting the capsule once daily for two weeks and twice weekly thereafter, and wherein upon contact of the dosage form with the vaginal mucosa, the composition comprising the estrogen is released into the vaginal tissue.

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