Trial reportMenopause (New York, N.Y.)2017
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.
Trial report in Menopause (New York, N.Y.), 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05457972 (Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients), which is not on this map. Cited by 21 papers, 4 of them syntheses that pooled 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.
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.
Postpartum Vaginal Estrogen for Sexual Function in Breastfeeding Patients: A Randomized Controlled Trial
Who cites it
21 citing papers in PubMed, 4 syntheses or guidelines pooled it, 81 citations in OpenAlex.
- Let's talk about sex: consensus guidelines of the GINECOR working group of the Spanish Society of Radiation Oncology: clinical recommendations after pelvic radiotherapy.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Guideline
- Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review.Annals of internal medicine · 2024Pooled it
- Systemic estradiol levels with low-dose vaginal estrogens.Menopause (New York, N.Y.) · 2020Pooled it
- Endometrial safety of low-dose vaginal estrogens in menopausal women: a systematic evidence review.Menopause (New York, N.Y.) · 2019Pooled it
- Physical characteristics and properties of estradiol softgel vaginal inserts.Menopause (New York, N.Y.) · 2020Trial
- Efficacy and safety of ospemifene in postmenopausal women with moderate-to-severe vaginal dryness: a phase 3, randomized, double-blind, placebo-controlled, multicenter trial.Menopause (New York, N.Y.) · 2019Trial
- Efficacy of Vaginal Estradiol or Vaginal Moisturizer vs Placebo for Treating Postmenopausal Vulvovaginal Symptoms: A Randomized Clinical Trial.JAMA internal medicine · 2018Trial
- Visual improvements in vaginal mucosa correlate with symptoms of VVA: data from a double-blind, placebo-controlled trial.Menopause (New York, N.Y.) · 2017Trial
- Patient acceptability and satisfaction with a low-dose solubilized vaginal estradiol softgel capsule, TX-004HR.Menopause (New York, N.Y.) · 2017Trial
- 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.Journal of women's health (2002) · 2017Trial
- TX-004HR vaginal estradiol has negligible to very low systemic absorption of estradiol.Menopause (New York, N.Y.) · 2017Trial
- Bile acids and nanotechnology as emerging platforms for drug delivery.Therapeutic delivery · 2026Review
- Vaginal Estrogen Utilization Among Medicare Beneficiaries With Genitourinary Syndrome of Menopause.JAMA network open · 2025Article
- Effectiveness and safety of hormone replacement therapy in the treatment of menopausal syndrome: a meta-analysis.American journal of translational research · 2025Review
- Efficacy and Safety of Intravaginal Estrogen in the Treatment of Atrophic Vaginitis: A Systematic Review and Meta-Analysis.Journal of menopausal medicine · 2024Article
- Estrogen alleviates acute and chronic itch in mice.Experimental and therapeutic medicine · 2023Article
- Microablative fractional radiofrequency for the genitourinary syndrome of menopause: protocol of randomised controlled trial.BMJ open · 2021Article
- Lights on MsFLASH: a review of contributions.Menopause (New York, N.Y.) · 2020Review
- Time to advocate for better science, and better treatments for women.Menopause (New York, N.Y.) · 2018Article
- Randomized, Double-Blind, Placebo-Controlled Study of Modified Erzhi Granules in the Treatment of Menopause-Related Vulvovaginal Atrophy.Evidence-based complementary and alternative medicine : eCAM · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo 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.
methodsIn 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. Secondary endpoints included severity of vaginal dryness and vulvar and/or vaginal itching or irritation. Endometrial histology and adverse events (AEs) were included in the safety endpoints.
resultsIn all, 764 women were randomized (modified intent-to-treat population, n = 747; mean age 59 y). Compared with placebo, all three doses of TX-004HR significantly improved the four co-primary endpoints (P < 0.0001 for all, except dyspareunia with 4 μg, P = 0.0149). Changes in cytology, pH, and dyspareunia were also significant at weeks 2, 6, and 8. Vaginal dryness and vaginal itching/irritation improved. Sex hormone binding globulin concentrations did not change with treatment. TX-004HR was well-tolerated, with no clinically meaningful differences in treatment-emergent AEs versus placebo, and no treatment-related serious AEs or deaths.
conclusionsTX-004HR (4, 10, and 25 μg) was safe, well-tolerated, and effective for treating moderate-to-severe dyspareunia within 2 weeks with minimal systemic estrogen exposure. This novel product may be a potential new treatment option for women experiencing postmenopausal vulvar and vaginal atrophy.
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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.