Study to Determine Efficacy & Safety of a Low Concentration Estriol (0.005%) in Postmenopausal Vaginal Atrophy.
Vaginal Atrophy
About this trial
This is an interventional treatment trial for Vaginal Atrophy focused on measuring Postmenopausal women
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.
Sites / Locations
- Hospital Sierrallana
- Hospital Ruber Internacional
- Centre Mèdic Teknon S.L.
- Fundació de Gestió Sanitària de l'Hospital de la Santa. Creu i Sant Pau
- Complejo Hospitalario Virgen de las Nieves
- Fundación Jiménez Díaz
- Complejo Universitario La Paz
- Hospital Universitario Virgen de la Arrixaca
- Hospital Universitario Central de Asturias
- Hospital Clínico Universitario de Valencia
- Hospital la Ribera de Alzira
- Hospital do Meixoeiro
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
0.005% Estriol group
Placebo group
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.
Placebo 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.