Genitourinary syndrome of menopause (GSM) MedDRA version: 20.0 Level: PT Classification code 10051775 Term: Postmenopause System Organ Class: 10041244 - Social circumstances
Conditions
Interventions
Trade Name: Blissel
Product Name: Blissel
Pharmaceutical Form: Vaginal gel
INN or Proposed INN: ESTRIOL
CAS Number: 50-27-1
Sponsors
ITF Research Pharma S.L.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Women between 45 and 75 years old. • Postmenopausal women (who have at least 12 months without menstruation) by natural process or by surgical intervention. • Women who present with vaginal symptoms resulting from vaginal atrophy, at least moderate-severe vaginal dryness, and in whom a local estrogen treatment is considered necessary to relieve their symptoms. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: • Women with a history of malignant or premalignant lesions in breast or endometrium, malignant colon or hepatic tumors, malignant melanoma, venous thromboembolic disorders (deep vein thrombosis, pulmonary embolism) or arterial thromboembolic disorders (cardiac ischemia, myocardial infarction, cerebrovascular accident) , peripheral arterial disease, thrombosis of the mesenteric artery, thrombosis of the renal artery or coagulopathies. • Women with vaginal bleeding of unknown etiology. • Women with uterovaginal prolapse grade II or higher, or signs and symptoms suggestive of infection of the genitals or urinary tract. • Women with an endometrial thickness equal to or greater than 4 mm measured by transvaginal ultrasound before the start of the study. • Women who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study. • Women who have received phytoestrogens within 1 month before the start of the study (including vaginal administration). • Women who have received hormone therapy in the 3 months before the start of the study (including the administration of estrogen via the vagina). • Women who are being treated with estrogen or progestin, tibolone or selective modulators of the estrogen receptor, antiepileptic and urinary antiseptics. • Women who have received long-term antibiotic treatment (for two or more weeks) in the last 3 months before the start of the study. • Women in treatment with medications such as: antiepileptic drugs, antibiotics and anti-infectives. • Women who, for any reason, the researcher considers that they are not candidates to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • Evaluate the efficacy of vaginal estriol gel at 0.005% on the different symptoms and signs of vaginal atrophy in postmenopausal women with symptoms of vaginal atrophy. • Evaluate the safety and tolerability of estriol vaginal gel at 0.005% administered during two weeks in postmenopausal women with symptoms of vaginal atrophy. • Evaluate the acceptability of estriol vaginal gel at 0.005% administered during two weeks in postmenopausal women with symptoms of vaginal atrophy. ;Main Objective: • The main objective is to evaluate the rapidity of action of vaginal estriol gel at 0.005% in the treatment of vaginal atrophy in postmenopausal women with symptoms of vaginal atrophy.;Primary end point(s): Changes in the vaginal epithelium maturation value compared to the baseline values ??after two weeks of treatment with estriol vaginal gel at 0.005%.;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in the value of vaginal maturation after one week of treatment with vaginal estriol gel at 0.005% against baseline values. Changes in vaginal pH after one and two weeks of treatment compared to baseline values. Changes in vaginal dryness and other symptoms and signs of vaginal atrophy after one and two weeks of treatment against baseline. Evolution of the symptoms collected in the diary of the patient in weeks 1 and 2 of treatment. Determination of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA). To evaluate the acceptability after two weeks of treatment with vaginal estriol gel at 0.005%. For its determination, the patient must answer a simple questionnaire regarding the properties that the product confers (moisturizing capacity and cleanliness of the product) and its evaluation in relation to the general effectiveness of the therapy. ;Timepoint(s) of evaluation of this end point: 14 days | — |
Countries
Spain
Contacts
Public ContactTeresa Bricio
ALPHA BIORESEARCH S.L.
Outcome results
None listed