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TX-004HR

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https://www.readbyqxmd.com/read/27922936/the-rejoice-trial-a-phase-3-randomized-controlled-trial-evaluating-the-safety-and-efficacy-of-a-novel-vaginal-estradiol-soft-gel-capsule-for-symptomatic-vulvar-and-vaginal-atrophy
#1
Ginger D Constantine, James A Simon, James H Pickar, David F Archer, Harvey Kushner, Brian Bernick, Gina Gasper, Shelli Graham, Sebastian Mirkin
OBJECTIVE: To evaluate the safety and efficacy of TX-004HR vaginal estradiol soft-gel capsules for moderate-to-severe dyspareunia associated with postmenopausal vulvar and vaginal atrophy. METHODS: In this randomized, double-blind, placebo-controlled, phase 3 study, postmenopausal women with a self-identified most bothersome symptom of dyspareunia received 4, 10, or 25 μg TX-004HR or placebo for 12 weeks. Four co-primary efficacy endpoints were change from baseline to week 12 in percentages of superficial and parabasal cells, vaginal pH, and severity of dyspareunia...
December 5, 2016: Menopause: the Journal of the North American Menopause Society
https://www.readbyqxmd.com/read/27914565/response-and-rebuttal-to-editorial-comment-on-tx-004hr-improves-sexual-function-as-measured-by-the-female-sexual-function-index-in%C3%A2-postmenopausal-women-with-vulvar-and-vaginal-atrophy-the%C3%A2-rejoice%C3%A2-trial
#2
Sheryl A Kingsberg, Leonard Derogatis, James A Simon, Ginger D Constantine, Shelli Graham, Brian Bernick, Gina Gasper, Sebastian Mirkin
No abstract text is available yet for this article.
December 2016: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/27914564/editorial-comment-on-tx-004hr-improves-sexual-function-as-measured-by-the-female-sexual-function-index-in-postmenopausal-women-with-vulvar-and-vaginal-atrophy-the-rejoice-trial
#3
https://www.readbyqxmd.com/read/27692842/tx-004hr-improves-sexual-function-as-measured-by-the-female-sexual-function-index-in-postmenopausal-women-with-vulvar-and-vaginal-atrophy-the-rejoice-trial
#4
Sheryl A Kingsberg, Leonard Derogatis, James A Simon, Ginger D Constantine, Shelli Graham, Brian Bernick, Gina Gasper, Sebastian Mirkin
INTRODUCTION: TX-004HR is an investigational, applicator-free, vaginal soft gel capsule containing low-dose solubilized 17β-estradiol. The phase 3, randomized, double-blinded, placebo-controlled, multicenter REJOICE trial has shown TX-004HR to be safe and effective for the treatment of moderate to severe dyspareunia in postmenopausal women with vulvar and vaginal atrophy (VVA). AIM: To evaluate the effect of TX-004HR on female sexual dysfunction in postmenopausal women with VVA...
December 2016: Journal of Sexual Medicine
https://www.readbyqxmd.com/read/26857443/pharmacokinetic-studies-of-solubilized-estradiol-given-vaginally-in-a-novel-softgel-capsule
#5
J H Pickar, J M Amadio, B A Bernick, S Mirkin
OBJECTIVE: To evaluate the bioavailability and safety of a novel vaginal capsule containing solubilized bioidentical 17β-estradiol for vulvar and vaginal atrophy and compare its pharmacokinetics with that of an approved vaginal estradiol tablet in healthy postmenopausal women. METHODS: Two randomized, single-dose, two-way cross-over, relative bioavailability trials compared the pharmacokinetics of a solubilized vaginal estradiol softgel capsule (TX-004HR, test) with that of a vaginal estradiol tablet (Vagifem®, reference) in postmenopausal women (aged 40-65 years) at 10-μg and 25-μg doses...
April 2016: Climacteric: the Journal of the International Menopause Society
https://www.readbyqxmd.com/read/25557757/emerging-hormonal-treatments-for-menopausal-symptoms
#6
REVIEW
Andrea R Genazzani, Barry S Komm, James H Pickar
INTRODUCTION: The majority of women experience bothersome symptoms postmenopause (e.g., hot flushes, vaginal symptoms). Estrogen receptor agonists remain the most effective options for ameliorating menopausal symptoms. However, use of hormonal therapies has declined in the wake of issues raised by the Women's Health Initiative trials. As a result, there is a need for new safe and effective alternatives to estrogen-progestogen hormone therapy. AREAS COVERED: We review the efficacy and safety profile of hormonal menopausal therapies that are in Phase III clinical trials or recently approved...
March 2015: Expert Opinion on Emerging Drugs
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