Document Detail


The therapeutic effect of a new ultra low concentration estriol gel formulation (0.005% estriol vaginal gel) on symptoms and signs of postmenopausal vaginal atrophy: results from a pivotal phase III study.
MedLine Citation:
PMID:  22914208     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of a new low-concentration estriol formulation (0.005% estriol vaginal gel), providing an ultra low dose of estriol per application (50 μg), for the local treatment of postmenopausal vaginal atrophy. METHODS: Postmenopausal women with symptoms and signs of vaginal atrophy were enrolled in a prospective, double-blind, placebo-controlled study. Women received either 1 g of vaginal gel containing 50 μg of estriol or placebo gel, daily for 3 weeks and then twice weekly up to 12 weeks. A cytological vaginal study, evaluation of vaginal pH, and assessment of symptoms and signs of vaginal atrophy were performed, and changes between baseline and weeks 3 and 12 were assessed. Adverse events were recorded. RESULTS: A total of 167 women were included (114 received estriol and 53 received placebo). After 12 weeks of therapy, a superiority of estriol compared with placebo gel was shown in the change in maturation value and vaginal pH (P < 0.001 and P < 0.001, respectively). The superiority of estriol was well demonstrated in improvement of vaginal dryness (P = 0.001) and the Global Symptom Score (P = 0.018). Estriol gel proved also superior in the improvement of several of the most outstanding vaginal signs of vaginal atrophy evaluated. After 3 weeks, estriol gel also showed a superiority over the placebo gel in most symptoms and signs evaluated. Treatment-related adverse events were similar among groups. CONCLUSIONS: 0.005% Estriol vaginal gel, a new formulation providing an ultra low dose of estriol per application, was shown to be safe and effective in the treatment of postmenopausal vaginal atrophy.
Authors:
Antonio Cano; José Estévez; Ramón Usandizaga; José L Gallo; Misericord Guinot; Juan L Delgado; Elena Castellanos; Eloy Moral; Concepción Nieto; Jaime Moscoso Del Prado; Javier Ferrer
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-8-20
Journal Detail:
Title:  Menopause (New York, N.Y.)     Volume:  -     ISSN:  1530-0374     ISO Abbreviation:  Menopause     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-8-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9433353     Medline TA:  Menopause     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
From the 1Pediatrics Obstetrics and Gynecology Department, Valencia University, HU Dr Preset, Valencia, Spain; 2Obstetrics and Gynecology Department, HU Valdecilla, Santander, Spain; 3Obstetrics and Gynecology Department, Universidad Autonoma de Madrid, HU La Paz, Madrid, Spain; 4Obstetrics and Gynecology Unit, Hospital Virgen de las Nieves, Granada, Spain; 5Obstetrics and Gynecology Department, HU San Pau, Barcelona, Spain; 6Obstetrics and Gynecology Department, HU Virgen de Arrixaca, Murcia, Spain; 7Obstetrics and Gynecology Unit, Clinica Teknon, Barcelona, Spain; 8Obstetrics and Gynecology Unit, Complexo Hospitalario Pontevedra, Pontevedra, Spain; 9Medical and 10R&D Departments, Italfarmaco SA, Madrid, Spain; and 11Obstetrics and Gynecology Department, Universidad de Oviedo, Hospital Central de Asturias, Oviedo, Spain.
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