WHO ICTRP trial
Clinical trial to evaluate the efficacy of a 0.005% estriol vaginal gel in the…
EUCTR2018-001481-42-ES · EU Clinical Trials Register · Authorised
Key facts
| Trial ID | EUCTR2018-001481-42-ES |
|---|---|
| Public title | Clinical trial to evaluate the efficacy of a 0.005% estriol vaginal gel in the prevention of recurrent urinary tract infections in postmenopausal women with vaginal atrophy. |
| Scientific title | Prospective, multicentre, randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of a 0.005% estriol vaginal gel in the prevention of recurrent urinary tract infections in postmenopausal women with vaginal atrophy. "BLISSURE study" - BLISSURE |
| Primary sponsor | ITF RESEARCH PHARMA S.L.U. |
| Registry | EU Clinical Trials Register |
| Recruitment status | Authorised |
| Study type | Interventional clinical trial of medicinal product |
| Phase | Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no |
| Countries | Spain |
| Conditions | Recurrent Urinary Tract Infection (UTI) in postmenopausal women with vaginal atrophy. MedDRA version: 20.0 Level: LLT Classification code 10038140 Term: Recurrent urinary tract infection System Organ Class: 100000004862 ;Therapeutic area… |
| Interventions | Trade Name: BLISSEL Product Name: BLISSEL Pharmaceutical Form: Vaginal gel INN or Proposed INN: ESTRIOL Current Sponsor code: ITFE-2026-C11 Other descriptive name: Estriol Vaginal Gel Concentration unit: % percent Concentration type: equal… |
| Registration date | Sep 17, 2018 |
| Target size | 120 |
| Secondary IDs | ITFE-2026-C11 |
| Registry page | clinicaltrialsregister.eu |
At a glance
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Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: