1. Efficacy and safety of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause: A randomized double-blind placebo-controlled trial.
- Author
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Muiños Fernández N, Martínez Salamanca JI, Pardo González de Quevedo JI, Diz Morales MP, Palomo Alameda L, Duce Tello S, González Béjar M, Rabanal Carrera A, Rosado Martín J, Noguera Vera L, Doyle Sanchez A, Rodríguez Mariblanca A, and García Aguilar E
- Subjects
- Humans, Female, Double-Blind Method, Middle Aged, Administration, Intravaginal, Female Urogenital Diseases prevention & control, Female Urogenital Diseases drug therapy, Aged, Syndrome, Vagina microbiology, Estriol administration & dosage, Urinary Tract Infections prevention & control, Postmenopause, Vaginal Creams, Foams, and Jellies administration & dosage
- Abstract
Objectives: This study evaluated the efficacy of an ultra-low-dose 0.005 % estriol vaginal gel in the prevention of urinary tract infections in postmenopausal women with genitourinary syndrome of menopause., Study Design: Randomized, double-blind, placebo-controlled, multicenter clinical trial conducted across 28 Spanish sites involving specialists in gynecology, urology, and primary care. A total of 108 postmenopausal women were randomly assigned in a 1:1 ratio to receive 1 g of vaginal gel with 50 micrograms of estriol or an identical moisturizing vaginal gel without estriol., Main Outcome Measures: The primary outcome was the number of episodes of urinary tract infection by the end of the 24-week treatment. Secondary measures encompassed percentage of patients without recurrence, time to first recurrence, use of antibiotic treatment, vaginal pH, safety, and tolerability, among others., Results: The incidence rate of urinary tract infections (new cases per 100 women-year) was 26 % lower in the group that received estriol vs. the group that received placebo (32.34 vs. 43.76 (RR = 0.74) p < 0.001). The frequency of urinary tract infections fell during treatment in all patients in the estriol group. Favorable pH changes from baseline were observed in the estriol arm at all follow-up visits., Conclusions: Ultra-low-dose 0.005 % estriol vaginal gel is safe and effective in preventing recurrent urinary tract infections in postmenopausal women with genitourinary syndrome of menopause, reducing the incidence and potentially decreasing the susceptibility to urogenital infections by improving vaginal pH. Study registration N°: 2018-001481-42. Date of registration: 09-04-2018., Competing Interests: Declaration of competing interest Susana Duce Tello declares to have received payments or fees for lectures, presentations, manuscript writing or educational events from Novartis, Pfizer. Payment for expert testimony from Italfarmaco, and support for attending meetings and/or travel from Viatris. Milagros González has been sponsored in communications at conferences and training courses by Chiesi, Menarini, GSK, Pfizer, Daichi Sankio, Alter, Astra Zeneca and Zentivia. Javier Rosado declares to have received fees for lectures and as a consultant from Astra-Zéneca, Boehringer Ingelgheim, Chiesi, Italfármaco, Merck Sharp and Dohme, Novartis, Pfizer, Sanofi-Aventis, Recordati, Daichi-Sankyo, Almirall, Servier, Medtronic. Laura Noguera, Ana Doyle Sanchez, Amelia Rodríguez and Eva Aguilar are full time employees at ITF Research Pharma. All other authors declare that they have no competing of interest., (Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
- Published
- 2024
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