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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

Cano, Antonio MD, PhD1; Estévez, José MD2; Usandizaga, Ramón MD, PhD3; Gallo, José L. MD4; Guinot, Misericord MD, PhD5; Delgado, Juan L. MD6; Castellanos, Elena MD, PhD7; Moral, Eloy MD8; Nieto, Concepción MD, PhD9; del Prado, Jaime Moscoso PhD10; Ferrer, Javier MD, PhD11

doi: 10.1097/gme.0b013e3182518e9a
Original Articles

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.

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.

Received January 5, 2012; revised and accepted February 22, 2012.

Funding/support: This study was funded by Italfarmaco SA.

Financial disclosure/conflicts of interest: All the authors received compensation for their activity as investigators of the study. Dr. Nieto and Dr. Moscoso del Prado are full-time employees of Italfarmaco SA.

Address correspondence to: Concepción Nieto, MD, PhD, Italfarmaco SA, C/ San Rafael 3, Poligono Industrial de Alcobendas, 28108 Madrid, Spain. E-mail: concepción@itfsp.com

©2012The North American Menopause Society