Short and long-term effect of polycarbophil vaginal gel on vaginal atrophy of peri- and post-menopausal women. The TRIPLE study.

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  • Additional Information
    • Source:
      Publisher: Elsevier Scientific Publishers Country of Publication: Ireland NLM ID: 0375672 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1872-7654 (Electronic) Linking ISSN: 03012115 NLM ISO Abbreviation: Eur J Obstet Gynecol Reprod Biol Subsets: MEDLINE
    • Publication Information:
      Publication: Limerick : Elsevier Scientific Publishers
      Original Publication: Amsterdam, Excerpta Medica.
    • Subject Terms:
      Atrophy*/drug therapy ; Vaginal Creams, Foams, and Jellies*/administration & dosage ; Postmenopause* ; Vagina*/pathology ; Vagina*/drug effects ; Acrylic Resins*/administration & dosage ; Acrylic Resins*/therapeutic use ; Vaginal Diseases*/drug therapy ; Vaginal Diseases*/pathology; Humans ; Female ; Middle Aged ; Perimenopause ; Administration, Intravaginal ; Treatment Outcome ; Adult
    • Abstract:
      Objectives: This TRIPLE study was aimed to evaluate the efficacy of polycarbophil vaginal gel (PCV) in treating symptoms of vaginal atrophy (VA) of peri- and post-menopausal women.
      Materials and Methods: Sexually active women in peri- (n = 29) and post-menopause (n = 54) suffering from VA, were progressively enrolled and treated for 30 days with PCV. Those wishing to continue (n = 73) were treated for additional 180 days. PCV was administered as one application twice a week. The vaginal health index (VHI; range 5 to 25) and the visual analogue score (VAS range for 0 to 100 mm for each item) for vaginal dryness, irritation, and pain at intercourse, along with the global symptoms score (GSS; range 1 to 15) and treatment safety, were evaluated at baseline and after 30 days. In those continuing the treatment an evaluation was performed after additional 180 days.
      Results: Women in peri and post-menopause were of 48.7 ± 3.3 years and 57.5 ± 5.7 years old., respectively. At baseline all outcomes were significantly worse (p<0.002) in postmenopausal group, except the VHI (p < 0.056). After 30 days VHI increased (p < 0.001) of 4.1 ± 0.5 (mean ± SE), and 5.1 ± 0.4 in peri- and post-menopausal women respectively. VAS of vaginal dryness decreased (p < 0.001) of -24.4 ± 3.6, and -52.7 ± 2.6 (p < 0.001), VAS of irritation decreased (p<0.001) of -18.6 ± 4.4 and -47.8 ± 3.2, VAS of pain decreased (p < 0.001) of -26.2 ± 4.3 and -55.6 ± 3.1 and the GSS decreased (p < 0.001) of -3.9 ± 0.3, and -4.9 ± 0.2, in peri and post-menopausal women, respectively. All the modifications were significantly greater (p < 0.001)(p < 0.032 for GSS) in postmenopausal women, and after 30 days all outcomes were similar in the two groups of women. In comparison to baseline, after 210 days of treatment VHI increased of 7.7 ± 0.3 (p < 0.001), VAS of vaginal dryness decreased of -53.6 ± 1.9 (p < 0.001) VAS of irritation of -42.6 ± 1.4 (p < 0.001) VAS of pain of -46.7 ± 2.3 (p < 0.001) and the GSS of -6.5 ± 0.2 ± 0.2 (p < 0.001). All outcomes improved (p < 0.001) over the values observed after 30 days of treatment (p < 0.001). No side effect was reported.
      Conclusions: In peri- and post-menopausal women PCV administration rapidly improves VA symptoms, and its prolongation up to 6 months further increases its efficacy.
      Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Angelo Cagnacci received a fee as invited speaker for Italfarmaco, Shionogi, Bayer, Gedon-Richter, Theramex, MSD and Exeltis. Dionisio Franco Barattini is employed at Opera CRO, the Contract Research Organization that managed the study. Elena Casolati is a medical consultant for Italfarmaco SpA. Alberto Pecoroni and Mario Mangrella are employed at Italfarmaco SpA. Serban Marius Rosu and Liviu Cristian Patrascu certifies that there is no conflict of interest with any financial organization regarding the material discussed in the manuscript.
      (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
    • Contributed Indexing:
      Keywords: Late menopausal transition; Polycarbophil; Post-menopause; Sexuality; Vaginal dryness
    • Accession Number:
      0 (Vaginal Creams, Foams, and Jellies)
      0 (Acrylic Resins)
      8F049NKY49 (calcium polycarbophil)
    • Publication Date:
      Date Created: 20240701 Date Completed: 20240718 Latest Revision: 20240718
    • Publication Date:
      20240719
    • Accession Number:
      10.1016/j.ejogrb.2024.06.033
    • Accession Number:
      38950453