Evidence map›Paper›PMID 28355090›Full record

Trial reportJournal of women's health (2002)2017

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.

Ginger D Constantine, Celine Bouchard, James H Pickar, David F Archer, Shelli Graham, Brian Bernick, Sebastian Mirkin

Registry-linked trialOpen access · hybridAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of women's health (2002), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02253173 (A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy), which is not on this map. Cited by 2 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed, 1 pooled it
1.1field-weighted citation impact, top 22% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02253173 phase3completednot on this map

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multi-center Trial to Evaluate the Safety and Efficacy of TX-004HR in Postmenopausal Women With Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy

TypeinterventionalSponsorTherapeuticsMDRan2014 to 2015Enrolled764ConditionsVulvovaginal Atrophy, Menopause, Dyspareunia, Painful IntercourseArmsEstradiol, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Trial
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 5 institutions in 4 countries.

Ginger D Constantine1 EndoRheum Consultants, LLC , Media, Pennsylvania.
Celine Bouchard2 Clinique de Recherche en Santé des Femmes , Quebec City, Canada .
James H Pickar3 Columbia University Medical Center , New York, New York.
David F Archer4 Department of Obstetrics and Gynecology, Clinical Research Center , Eastern Virginia Medical School, Norfolk, Virginia.
Shelli Graham5 TherapeuticsMD , Boca Raton, Florida.
Brian Bernick5 TherapeuticsMD , Boca Raton, Florida.
Sebastian Mirkin5 TherapeuticsMD , Boca Raton, Florida.
TherapeuticsMD (United States) · USBaum Consult · DEColumbia University Irving Medical Center · USEastern Virginia Medical School · USHôpital Femme Mère Enfant · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe 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.

methodsThe REJOICE trial evaluated the efficacy of 4-, 10-, and 25-μg doses of TX-004HR in postmenopausal women (40-75 years) with VVA and a self-identified most bothersome symptom of moderate-to-severe dyspareunia. Prespecified subgroup analyses of the four co-primary endpoints (percentages of superficial cells and parabasal cells, vaginal pH, and severity of dyspareunia) were analyzed with respect to age, BMI, uterine status, pregnancy status, and vaginal births. Each dose was compared with placebo for change from baseline to week 2 through week 12, respectively.

resultsTX-004HR significantly improved superficial cells, parabasal cells, and vaginal pH from baseline to weeks 2 and 12 in most subgroups. All TX-004HR doses numerically reduced the severity of dyspareunia by 2 weeks and maintained efficacy over 12 weeks, with many of the subgroups having statistically significant improvement relative to placebo.

conclusionsTX-004HR was efficacious for treating symptomatic VVA, and it demonstrated a consistency of effect when women's age, BMI, uterine status, pregnancy status, and vaginal births were evaluated. Clinical Trial Identifier: NCT02253173.

Indexed as

PostmenopauseAdministration, IntravaginalAgedDouble-Blind MethodDyspareuniaEstradiolFemaleHumansMiddle AgedTreatment OutcomeVaginaVulvaEstradiol17-β estradiolagebody mass indexdyspareuniavaginal atrophy

Identifiers

PMID28355090
PMCPMC5512333
OpenAlexW2600400743

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.