Trial reportMenopause (New York, N.Y.)2018
A randomized, multicenter, double-blind study to evaluate the safety and efficacy of estradiol vaginal cream 0.003% in postmenopausal women with dyspareunia as the most bothersome symptom.
Trial report in Menopause (New York, N.Y.), 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis 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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.
- Hormonal Treatments and Vaginal Moisturizers for Genitourinary Syndrome of Menopause : A Systematic Review.Annals of internal medicine · 2024Pooled it
- Association between postmenopausal vulvovaginal discomfort, vaginal microbiota, and mucosal inflammation.American journal of obstetrics and gynecology · 2021Trial
- The qualitative experience of sexuality in ageing women: a narrative review.Frontiers in global women's health · 2026Review
- Local estradiol deposition in a rat rotator cuff repair model: proof of concept.JSES international · 2025Article
- Scratching the Surface: A Comprehensive Guide to Understanding and Managing Vulvovaginal Itching.American journal of clinical dermatology · 2025Review
- Locally administered nanosuspension increases delivery of estradiol for the treatment of vaginal atrophy in mice.Drug delivery and translational research · 2025Article
- The Involvement of Glutamate-mGluR5 Signaling in the Development of Vulvar Hypersensitivity.International journal of molecular sciences · 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
- Understanding the Interplay Between Premenstrual Dysphoric Disorder (PMDD) and Female Sexual Dysfunction (FSD).Cureus · 2024Review
- Hormone therapy for sexual function in perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2023Review
- Estrogen alleviates acute and chronic itch in mice.Experimental and therapeutic medicine · 2023Article
- Modern management of genitourinary syndrome of menopause.Faculty reviews · 2021Review
- Investigating the effect of vitamin D vaginal suppository on sexual function among postmenopausal women: study protocol for a randomized controlled trial.BMC women's health · 2020Article
- Sexual functioning in 4,418 postmenopausal women participating in UKCTOCS: a qualitative free-text analysis.Menopause (New York, N.Y.) · 2019Article
- Female Sexual Function at Midlife and Beyond.Obstetrics and gynecology clinics of North America · 2018Review
- Time to advocate for better science, and better treatments for women.Menopause (New York, N.Y.) · 2018Article
Corrections and comments
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Authors and funding
5 authors at 4 institutions in 1 country.
Funding
Abstract
objectiveVulvovaginal atrophy (VVA) is characterized by vaginal changes, dyspareunia, and itching/irritation. Efficacy and safety of a lower-dose estradiol vaginal cream (0.003%) were evaluated in postmenopausal women with VVA-related dyspareunia.
methodsThis was a phase 3, randomized, double-blind, placebo-controlled study. Sexually active postmenopausal women with moderate-severe dyspareunia as the most bothersome symptom, ≤5% vaginal superficial cells, and vaginal pH >5.0 were randomized (1:1) to 0.003% estradiol vaginal cream (15 μg estradiol; 0.5 g cream) or placebo (0.5 g cream) applied daily for 2 weeks followed by three applications/week for 10 weeks. Coprimary outcomes were changes in dyspareunia severity, vaginal cytology, and vaginal pH from baseline to final assessment. Additional efficacy outcomes and safety were assessed.
resultsA total of 550 participants (average age, 58 y) were randomized. Compared with placebo, estradiol reduced dyspareunia severity (mean change from baseline ± SD: -1.5 ± 1.0 estradiol vs -1.2 ± 0.9 placebo), decreased vaginal pH (-1.36 ± 0.89 vs -0.53 ± 0.92), and improved vaginal cytology (percentage superficial and parabasal cells 10.1 ± 16.7 vs 1.4 ± 6.1 and -48.5 ± 45.1 vs -14.6 ± 39.6; P < 0.001, all) at the final assessment. In addition, estradiol decreased dyspareunia severity at weeks 8 and 12, vaginal/vulvar irritation/itching at weeks 4 and 12, and dryness at week 12 versus placebo (P < 0.01, all). VVA severity, pH, and cytology improved at week 12 with estradiol versus placebo (P < 0.001, all). Vulvovaginal mycotic infections were more frequent with estradiol. One serious event leading to discontinuation occurred with estradiol. No deaths occurred.
conclusionsLower-dose estradiol vaginal cream (0.003%) dosed three applications/week is an effective and well-tolerated treatment for VVA-related dyspareunia.
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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.