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

• Status: Completed
• Trial end date: 2009-02-23
• Target enrollment: 0
• Participant gender: Female

Summary

Randomized, double-blind, placebo-controlled multicentre study, with parallel groups, to determine the efficacy and safety of a new low-concentration estriol formulation (ITFE-2026 0.005%) for application by vaginal route in the treatment of postmenopausal vaginal atrophy.

Primary objective:

• To evaluate the efficacy of 0.005% Estriol vaginal gel by evaluation of the change in the maturation value of the vaginal epithelium (MV) after 12 weeks of treatment.

Secondary objectives:

• To determine the variation of the vaginal pH, as well as symptoms and signs suggestive of vaginal atrophy after 12 weeks of treatment.

• To study the variation of the MV, pH and symptoms and signs suggestive of vaginal atrophy after an initial observation period of 3 weeks.

• To evaluate the safety of 0.005% Estriol vaginal gel

• To evaluate the acceptability of 0.005% Estriol vaginal gel

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Italfarmaco S.A

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.