{
    "abstract": "To evaluate the efficacy and safety of a single injection session of cross-linked hyaluronic acid gel for vulvovaginal atrophy, versus placebo.\nTwo-step study comprising a 12-week randomised, placebo-controlled, single-blind phase, followed by an open-label phase. Eligible postmenopausal women with vulvovaginal atrophy were randomised (2:1) to a single injection session of either hyaluronic acid or placebo. This is the report of the single-blind phase.\nThe primary outcome was the mean change in the severity score for the most bothersome symptom at 12\u00a0weeks compared with baseline. Secondary outcomes included differences in scores for individual vulvovaginal atrophy symptoms, score on the Female Sexual Function Index and vaginal pH.\nA total of 116 of the 117 patients in the randomised population contributed outcome data to the study (79 receiving hyaluronic acid and 37 placebo). Compared with baseline, the mean score for the severity of the most bothersome symptom was significantly reduced in the hyaluronic acid arm at 12\u00a0weeks (between-group difference [95\u00a0% confidence interval]: -0.58 [-1.01; -0.16], p\u00a0=\u00a00.008). Similarly, there were significant reductions in mean scores for dryness (-0.87 [-1.27; -0.47]; p\u00a0<\u00a00.001) and dyspareunia (-0.65 [-1.09; -0.21]; p\u00a0=\u00a00.004) and improvement in score on the Female Sexual Function Index (3.81 [0.91; 6.72]; p\u00a0=\u00a00.011) in the hyaluronic acid group. There were no differences in itching/irritation, pain or vaginal pH in either group. Hyaluronic acid treatment was well tolerated.\nA single injection session of cross-linked hyaluronic acid is effective in reducing vulvovaginal symptoms and sexual dysfunction compared with placebo at 12\u00a0weeks, making it a suitable management option for moderate to severe vulvovaginal atrophy symptoms.\nNCT04219722 (https://clinicaltrials.gov/study/NCT04219722).",
    "authors": [
        {
            "affiliation": "Polyclinique Sant\u00e9 Atlantique, Avenue Claude Bernard, Saint-Herblain, 44800 Nantes, France.",
            "firstname": "Fabienne",
            "initials": "F",
            "lastname": "Marchand Lamiraud"
        },
        {
            "affiliation": "Clinique Aquitaine de la Femme, 33 Boulevard George V, 33000 Bordeaux, France.",
            "firstname": "Hichem",
            "initials": "H",
            "lastname": "Bensmail"
        },
        {
            "affiliation": "Service de Gyn\u00e9cologie M\u00e9dicale, Orthog\u00e9nie et Sexologie, H\u00f4pital Jeanne-de-Flandre, Centre Hospitalo-Universitaire, 2 rue Eug\u00e8ne Avin\u00e9e, 59037 Lille, France.",
            "firstname": "Carine",
            "initials": "C",
            "lastname": "Martin"
        },
        {
            "affiliation": "Gynaecology Centre, 49 Schuttersvest, 2800 Mechelen, Belgium.",
            "firstname": "Sofie",
            "initials": "S",
            "lastname": "Pelckmans"
        },
        {
            "affiliation": "Gynaecology private practice, 153/1a Lange Lozanastraat, 2018 Antwerpen, Belgium.",
            "firstname": "Firas",
            "initials": "F",
            "lastname": "Cha'ban"
        },
        {
            "affiliation": "Gynaecology private practice, 72 Boulevard de Strasbourg, 31000 Toulouse, France.",
            "firstname": "Aliette",
            "initials": "A",
            "lastname": "Siboni Frisch"
        },
        {
            "affiliation": "Gynaecology private practice, 61 Jozef van Elewijckstraat, 1853 Strombeek, Belgium.",
            "firstname": "Gulcan",
            "initials": "G",
            "lastname": "Deniz"
        },
        {
            "affiliation": "Gynaecology private practice, 17 Chauss\u00e9e de la Muette, 75016 Paris, France.",
            "firstname": "Pascale",
            "initials": "P",
            "lastname": "Sabban Serfati"
        },
        {
            "affiliation": "Gynaecology private practice, 7c Boulevard d'Avroy, 4000 Liege, Belgium.",
            "firstname": "Brigitte",
            "initials": "B",
            "lastname": "Caubo"
        },
        {
            "affiliation": "Gynaecology private practice, 6 Rue Fran\u00e7ois Rocca, 13008 Marseille, France.",
            "firstname": "Brice",
            "initials": "B",
            "lastname": "Gurriet"
        },
        {
            "affiliation": "Gynaecology private practice, 16 Boulevard Jacques Duclos, 40220 Tarnos, France.",
            "firstname": "Isabelle",
            "initials": "I",
            "lastname": "Petit Breuilh"
        },
        {
            "affiliation": "Mirha Multidisciplinar Women's Health and Pelvic Care Centre, 56 Alex Feldheimstraat, 1930 Zaventem, Belgium.",
            "firstname": "Ann Inge",
            "initials": "AI",
            "lastname": "Pastijn"
        },
        {
            "affiliation": "Gynaecology private practice, 88 Chemin de la Roseraie, 66000 Perpignan, France.",
            "firstname": "Nicolas",
            "initials": "N",
            "lastname": "Berreni"
        },
        {
            "affiliation": "Service de Chirurgie Gyn\u00e9cologique, H\u00f4pital Jeanne-de-Flandre, Centre Hospitalo-Universitaire, 2 rue Eug\u00e8ne Avin\u00e9e, 59037 Lille, France. Electronic address: michel.cosson@chu-lille.fr.",
            "firstname": "Michel",
            "initials": "M",
            "lastname": "Cosson"
        }
    ],
    "conclusions": null,
    "copyrights": "Copyright \u00a9 2025 The Authors. Published by Elsevier B.V. All rights reserved.",
    "doi": "10.1016/j.maturitas.2025.108264",
    "journal": "Maturitas",
    "keywords": [
        "Genitourinary syndrome of menopause (GSM)",
        "Hyaluronic acid",
        "Menopause",
        "Pain",
        "Vaginal dryness",
        "Vulvovaginal atrophy (VVA)"
    ],
    "methods": null,
    "publication_date": "2025-04-25",
    "pubmed_id": "40273666",
    "results": "A total of 116 of the 117 patients in the randomised population contributed outcome data to the study (79 receiving hyaluronic acid and 37 placebo). Compared with baseline, the mean score for the severity of the most bothersome symptom was significantly reduced in the hyaluronic acid arm at 12\u00a0weeks (between-group difference [95\u00a0% confidence interval]: -0.58 [-1.01; -0.16], p\u00a0=\u00a00.008). Similarly, there were significant reductions in mean scores for dryness (-0.87 [-1.27; -0.47]; p\u00a0<\u00a00.001) and dyspareunia (-0.65 [-1.09; -0.21]; p\u00a0=\u00a00.004) and improvement in score on the Female Sexual Function Index (3.81 [0.91; 6.72]; p\u00a0=\u00a00.011) in the hyaluronic acid group. There were no differences in itching/irritation, pain or vaginal pH in either group. Hyaluronic acid treatment was well tolerated.",
    "title": "Hyaluronic acid injection to treat symptoms of vulvovaginal atrophy in postmenopausal women: A 12-week randomised, placebo-controlled, multicentric study.",
    "xml": "<Element 'PubmedArticle' at 0x788506f35e90>"
}