| 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 |
Related Documents
:
|
10646048 - Comparison of racecadotril and loperamide in adults with acute diarrhoea. 12184518 - High-fiber diet supplementation in patients with irritable bowel syndrome (ibs): a mult... 19585728 - Irritable bowel syndrome: a mild disorder; purely symptomatic treatment. 11430708 - Efficacy of a packaged rice oral rehydration solution among children with cholera and c... 1891618 - Effects of psychological well-being, physical status, and social support on oxygen-depe... 19155748 - Melatonin fails to improve sleep or agitation in double-blind randomized placebo-contro... |
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. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
|
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Osteoporosis, fragility fracture, and periodontal disease: a cross-sectional study in Spanish postme...
Next Document: Self-reported and accelerometer-derived physical activity levels and coronary artery calcification p...