Intervention: Estriol
Trial phase: Phase 3
ATC code: G03CA04 | G03CC06
SMILES: [H][C@@]12CCc3cc(O)ccc3[C@@]1([H])CC[C@]1(C)[C@@H](O)[C@H](O)C[C@@]21[H]
Sex: Female
Age groups: Child | Adult | Older Adult
Healthy volunteers: No
Participants at risk: 114
Group description: 0.005% Estriol (50 μg/g) gel for vaginal administration. Route: Vaginal by a cannula inserted deep inside the vagina Single dose: 1 g of gel Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: single application 2 times per week.

Estriol: Gel for vaginal application
Eligibility criteria:
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 minimum vaginal dryness as a symptom stated by the patient, together with at least one sign of the disease verified by the investigator.

As symptoms the patient could state vaginal dryness, pruritus, burning, dyspareunia, dysuria or any other symptom that the investigator considered related to the presence of vaginal atrophy.
As signs the investigator assessed in the gynaecological examination with a speculum, a thinned vaginal mucosa or with flattening of folds, a dry, fragile and pale vaginal mucosa, the presence of petechiae or any other sign that the investigator considered indicative of the existence of vaginal atrophy
Patients with mammography carried out in the period of one year prior to inclusion in the study.
Patients able to understand the nature and purpose of the study, to cooperate with the investigator 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 a history 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) or arterial thromboembolic conditions (angor pectoris, myocardial infarction, cerebrovascular accident), peripheral arterial disease, mesenteric artery thrombosis, renal artery thrombosis
Coagulopathies
Vaginal bleeding of unknown etiology
Patients who had abnormal laboratory values at the start of the study that the investigator considered clinically relevant for the purposes of the present study.
Patients with signs and symptoms suggestive of infection of the genital or urinary tract at the start of the study.
Patients with any medical-surgical pathology, which was uncontrolled at the time of inclusion in the study.
Patients with any acute process whose handling or evolution the investigator considered could interfere in the development of the study.
Patients with endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound.
Patients with grade II or higher uterovaginal prolapse.
Patients who had received any type of vulvovaginal treatment in the 15 days prior to the start of the study.
Patients who had received phytoestrogens in the period of one month prior to the start of the study, including administration by vaginal route.
Patients who had received hormone therapy in the period of 3 months prior to the start of 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 under study (see the composition in section 3.3. of the protocol).
Patients who had participated in the experimental evaluation of any drug during the 8 weeks before the start of the present study.