Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.

Main Inclusion Criteria:

• Women of any age.
• Menopause with amenorrhea time ≥ 2 years, either due to natural or surgical menopause (bilateral oophorectomy).
• Presence of symptoms and signs of atrophy of the vaginal mucosa including at minimumvaginal dryness as a symptom stated by the patient, together with at least one sign ofthe disease verified by the investigator.
• As symptoms the patient could state vaginal dryness, pruritus, burning,dyspareunia, dysuria or any other symptom that the investigator consideredrelated to the presence of vaginal atrophy.
• As signs the investigator assessed in the gynaecological examination with aspeculum, a thinned vaginal mucosa or with flattening of folds, a dry, fragileand pale vaginal mucosa, the presence of petechiae or any other sign that theinvestigator considered indicative of the existence of vaginal atrophy
• Patients with mammography carried out in the period of one year prior to inclusion inthe study.
• Patients able to understand the nature and purpose of the study, to cooperate with theinvestigator and meet the study requirements.
• Patients who gave written informed consent to participate in the study.

Exclusion Criteria:

• Patients with contraindications for hormone therapy with estrogens because they had ahistory of:
• Malignant or premalignant lesions of the breasts or endometrium.
• Pathology of malignant colon tumour.
• Malignant melanoma
• Hepatic tumour pathology
• Venous thromboembolic conditions (deep vein thrombosis, pulmonary embolism) orarterial thromboembolic conditions (angor pectoris, myocardial infarction,cerebrovascular accident), peripheral arterial disease, mesenteric arterythrombosis, renal artery thrombosis
• Coagulopathies
• Vaginal bleeding of unknown etiology
• Patients who had abnormal laboratory values at the start of the study that theinvestigator considered clinically relevant for the purposes of the present study.
• Patients with signs and symptoms suggestive of infection of the genital or urinarytract at the start of the study.
• Patients with any medical-surgical pathology, which was uncontrolled at the time ofinclusion in the study.
• Patients with any acute process whose handling or evolution the investigatorconsidered could interfere in the development of the study.
• Patients with endometrial thickness equal to or greater than 4 mm measured bytransvaginal ultrasound.
• Patients with grade II or higher uterovaginal prolapse.
• Patients who had received any type of vulvovaginal treatment in the 15 days prior tothe start of the study.
• Patients who had received phytoestrogens in the period of one month prior to the startof the study, including administration by vaginal route.
• Patients who had received hormone therapy in the period of 3 months prior to the startof the study, including the administration of estrogens by vaginal route.
• Patients on treatment with drugs described in section 7.3 of the protocol
• Patients with a history of allergy to any of the components of the medication understudy (see the composition in section 3.3. of the protocol).
• Patients who had participated in the experimental evaluation of any drug during the 8weeks before the start of the present study.