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.
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.
Pediatrics Obstetrics and Gynecology Department, Valencia University, HU Dr Preset, Valencia, Spain.
Antonio
A
Cano
José
J
Estévez
Ramón
R
Usandizaga
José L
JL
Gallo
Misericord
M
Guinot
Juan L
JL
Delgado
Elena
E
Castellanos
Eloy
E
Moral
Concepción
C
Nieto
Jaime Moscoso
JM
del Prado
Javier
J
Ferrer
D001284:Atrophy / Q000188:drug therapy; D004311:Double-Blind Method; D004964:Estriol / Q000008:administration & dosage* / Q000009:adverse effects; D004967:Estrogens / Q000008:administration & dosage* / Q000009:adverse effects; D005260:Female; D006801:Humans; D006863:Hydrogen-Ion Concentration / Q000187:drug effects; D008875:Middle Aged; D017698:Postmenopause; D011446:Prospective Studies; D012720:Severity of Illness Index; D013030:Spain; D016896:Treatment Outcome; D014621:Vagina / Q000473:pathology*; D014622:Vaginal Creams, Foams, and Jellies / Q000008:administration & dosage / Q000009:adverse effects; D014623:Vaginal Diseases / Q000188:drug therapy*
D004967:Estrogens; D014622:Vaginal Creams, Foams, and Jellies; D004964:Estriol