TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol.

ABSTRACT:

Objective

To evaluate the pharmacokinetics of TX-004HR vaginal estradiol softgel capsules when used for treating moderate-to-severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy.

Methods

A substudy of the REJOICE trial (multicenter, double-blind, placebo-controlled, phase 3) evaluated the pharmacokinetics of 4, 10, and 25-μg TX-004HR doses once/d for 2 weeks, followed by twice/wk for 10 weeks. Serum samples obtained at 2, 4, 6, 10, and 24 hours postdose on days 1 and 14, and once on day 84, were analyzed for area under the serum concentration-time curve, tmax, Cmin, Cavg, and Cmax for estradiol, estrone, and estrone conjugates.

Results

Seventy-two women (mean 59 y) participated. TX-004HR 4 μg showed no statistical differences from placebo in estr

SUBMITTER: Archer DF 

PROVIDER: S-EPMC5404400 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature