Trial reportMenopause (New York, N.Y.)2020
Efficacy and safety of ultra-low dose 0.005% estriol vaginal gel for the treatment of vulvovaginal atrophy in postmenopausal women with early breast cancer treated with nonsteroidal aromatase inhibitors: a phase II, randomized, double-blind, placebo-controlled trial.
Trial report in Menopause (New York, N.Y.), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers, 4 of them syntheses that pooled it.
What it found
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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
19 citing papers in PubMed, 4 syntheses or guidelines pooled it, 41 citations in OpenAlex.
- Vaginal estrogen therapy for treatment of menopausal genitourinary syndrome among breast cancer survivors: a systematic review and meta-analysis.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2025Pooled it
- Measuring serum oestrogen levels in breast cancer survivors using vaginal oestrogens: a systematic review.Breast cancer research and treatment · 2024Pooled it
- A systematic review of randomised clinical trials - The safety of vaginal hormones and selective estrogen receptor modulators for the treatment of genitourinary menopausal symptoms in breast cancer survivors.Post reproductive health · 2023Pooled it
- Management of genitourinary symptoms in patients with breast cancer: an updated systematic review of available evidence from randomized trials.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2023Pooled it
- VEMORA: Vaginal Estrogen versus non-hormonal MOisturizer in women Receiving Aromatase inhibitors: a randomized, controlled trial.Breast cancer research and treatment · 2026Trial
- Survival Outcomes in Breast Cancer Patients With Use of Vaginal Estrogen Therapy: A SEER Analysis.JCO oncology practice · 2026Article
- Local estradiol deposition in a rat rotator cuff repair model: proof of concept.JSES international · 2025Article
- Vaginal health in breast cancer survivors: a practical clinical approach.Therapeutic advances in medical oncology · 2025Review
- Effect of Vaginal Laser and Topical Therapies on Vulvovaginal Atrophy Symptoms in Breast Cancer Patients: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2024Review
- Efficacy and Safety of Intravaginal Estrogen in the Treatment of Atrophic Vaginitis: A Systematic Review and Meta-Analysis.Journal of menopausal medicine · 2024Article
- Clinical guidelines for managing menopausal symptoms in women with (a history of) breast cancer.Facts, views & vision in ObGyn · 2023Article
- Clinical Practice Strategies to Address Sexual Health in Female Cancer Survivors.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2023Review
- Hormone therapy for sexual function in perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2023Review
- Therapeutic Choices for Genitourinary Syndrome of Menopause (GSM) in Breast Cancer Survivors: A Systematic Review and Update.Pharmaceuticals (Basel, Switzerland) · 2023Review
- Early Effect of 0.005% Estriol Vaginal Gel on Symptoms and Signs of Vulvovaginal Atrophy.Journal of menopausal medicine · 2022Article
- Management of genitourinary syndrome of menopause in breast cancer survivors: An update.World journal of clinical oncology · 2022Review
- Pharmacotherapy for Sexual Dysfunction in Women.Current psychiatry reports · 2022Review
- Hormonal Approach for Postmenopausal Vulvovaginal Atrophy.Frontiers in reproductive health · 2021Review
- High-Throughput Metabolomics Discovers Metabolic Biomarkers and Pathways to Evaluating the Efficacy and Exploring Potential Mechanisms of Osthole Against Osteoporosis Based on UPLC/Q-TOF-MS Coupled With Multivariate Data Analysis.Frontiers in pharmacology · 2020Article
Corrections and comments
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Authors and funding
8 authors at 5 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveTo assess the efficacy and safety of ultra-low dose 0.005% estriol vaginal gel in women with breast cancer receiving nonsteroidal aromatase inhibitors (NSAIs) and experiencing treatment-related vulvovaginal symptoms and signs.
methodsWomen with hormone receptor-positive early breast cancer receiving NSAIs were randomized to either estriol vaginal gel or placebo for 12 weeks. Vaginal maturation, vaginal pH, and total and individual scores of symptoms and signs of vulvovaginal atrophy were assessed at baseline and at weeks 3 and 12; sexual functioning was also evaluated using the Female Sexual Functioning Index (FSFI) questionnaire, as well as circulating estrogens, follicle-stimulating hormone (FSH) and luteinizing hormone (LH).
resultsSixty-one women with a mean age of 59 years were included: 50 received 0.005% estriol vaginal gel and 11 received placebo. Active treatment significantly improved maturation value and pH, vaginal dryness and global scores of symptoms and signs. Active treatment also increased the total FSFI score and all the FSFI domains, with the exception of pain. Small oscillations were observed in FSH and LH, which remained within the postmenopausal range. Estriol levels increased initially and normalized by week 12, and estradiol and estrone remained mostly undetectable throughout the study.
conclusionsUltra-low dose 0.005% estriol vaginal gel showed efficacy in improving the symptoms and signs of vulvovaginal atrophy. These results, together with minimal oscillations in hormonal levels throughout the treatment, support the use of ultra-low dose 0.005% estriol vaginal gel as a treatment option for vulvovaginal atrophy in women with breast cancer receiving NSAIs with an indication for treatment with vaginal estrogens. : Video Summary:http://links.lww.com/MENO/A531.
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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.