Prospective and open clinical trial to evaluate the rapidity of action of a 0.005% estriol vaginal gel on the signs and symptoms of vaginal atrophy in postmenopausal women. BLISSET Study

Phase 1

• Conditions: Genitourinary syndrome of menopause (GSM); MedDRA version: 20.0 Level: PT Classification code 10051775 Term: Postmenopause System Organ Class: 10041244 - Social circumstances; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2019-001435-31-ES
• Lead Sponsor: ITF Research Pharma S.L.U.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-06-11
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 40

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

• 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 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.<br><br> • Evaluate the safety and tolerability of estriol vaginal gel at 0.005% administered during two weeks in postmenopausal women with symptoms of vaginal atrophy.<br><br> • Evaluate the acceptability of estriol vaginal gel at 0.005% administered during two weeks in postmenopausal women with symptoms of vaginal atrophy.<br> ;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