Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women | Zendy

Ginger D. Constantine | Zendy; Céline Bouchard | Zendy; James H. Pickar | Zendy; David F. Archer | Zendy; Shelli Graham | Zendy; Brian Bernick | Zendy; Sebastián Mirkin | Zendy

Open Access

Consistency of Effect with a Low-Dose, Estradiol Vaginal Capsule (TX-004HR): Evaluating Improvement in Vaginal Physiology and Moderate-to-Severe Dyspareunia in Subgroups of Postmenopausal Women

Author(s) -

Ginger D. Constantine,

Céline Bouchard,

James H. Pickar,

David F. Archer,

Shelli Graham,

Brian Bernick,

Sebastián Mirkin

Publication year - 2017

Publication title -

journal of women s health

Language(s) - English

Resource type - Journals

SCImago Journal Rank - 1.195

H-Index - 98

eISSN - 1931-843X

pISSN - 1540-9996

DOI - 10.1089/jwh.2016.6187

Subject(s) - medicine , vaginal atrophy , placebo , pregnancy , vagina , gynecology , menopause , body mass index , randomized controlled trial , obstetrics , surgery , alternative medicine , pathology , biology , genetics

The 12-week, randomized, double-blind, placebo-controlled, multicenter, phase 3 REJOICE trial demonstrated that TX-004HR, an investigational, applicator-free, low-dose vaginal softgel capsule containing solubilized 17β-estradiol, effectively and rapidly treats symptoms of vulvar and vaginal atrophy (VVA) with negligible to very low systemic absorption. The aim of this analysis was to assess whether the efficacy of TX-004HR varies with age, body mass index (BMI), uterine status, pregnancy status, and vaginal delivery.

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