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
Conditions
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 un
Sponsors
ITF RESEARCH PHARMA S.L.U.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women between 55 and 75 years old. 2. Postmenopausal women (who have at least 12 months without menstruation) by natural process or by surgical intervention. 3. Women with vaginal dryness. 4. Women with a history of episodes of symptomatic UTIs of: 4a) at least 3 episodes of UTIs in the last 12 months or 4b) at least 2 episodes of UTIs in the last 6 months. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Women with presence of symptomatic urinary infection confirmed microbiologically by uroculture of the sample taken during the screening visit. 2. Women with asymptomatic bacteriuria determined by urine culture of the sample taken at the screening visit. 3. 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. 4. Women with vaginal bleeding of unknown etiology. 5. Women who have received any type of vulvovaginal treatment in the 15 days prior to the start of the study treatment (baseline visit). 6. Women who received phytoestrogens within 1 month before the start of the study treatment (baseline visit), including vaginal administration. 7. Women who have received hormone therapy in the 3 months before the start of the study treatment (baseline visit), including the vaginal administration of estrogens. 8. Women who are being treated with estrogen or progestin, tibolone or selective modulators of the estrogen receptor, antiepileptic and urinary antiseptics. 9. Women who have received long-term antibiotic treatment (for two or more weeks) in the last 3 months before the start of the study treatment. 10. Women with anatomical or functional injuries of the urogenital tract. 11. Women with permanent urinary catheter. 12. Women diagnosed with diabetes mellitus. 13. Women diagnosed with severe renal or hepatic failure. 14. Women with neurological pathologies. 15. Immunosuppressed women. 16. Women with vesicoureteral reflux. 17. Women with urinary incontinence due to overactive bladder. 18. Women who are currently participating or have participated in the last 3 months in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluate the efficacy of 0.005% estriol vaginal gel to prevent urinary tract infections in postmenopausal women with vaginal atrophy and recurrent urinary tract infections.;Secondary Objective: - Evaluate the effect of 0.005% estriol vaginal gel on the presence of asymptomatic bacteriuria in postmenopausal women with recurrent urinary tract infections. - Evaluate the effect of 0.005% estriol vaginal gel on the different symptoms and urinary signs, and on vaginal pH in postmenopausal women with recurrent urinary tract infections. - Evaluate the safety and tolerability of vaginal estriol gel at 0.005% in postmenopausal women with recurrent urinary tract infections. - Evaluate the acceptability of 0.005% estriol vaginal gel in postmenopausal women with recurrent urinary tract infections.;Primary end point(s): Number of episodes of urinary tract infection at the end of treatment (week 24).;Timepoint(s) of evaluation of this end point: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): I. Number of episodes of urinary tract infections occurring in the first 3, 12 and 18 weeks. II. Percentage of patients who do not experience a recurrence throughout the treatment. III. Time to first recurrence IV. Days of antibiotic treatment. V. Number of episodes of asymptomatic bacteriuria recorded in the first 3, 12, 18 and 24 weeks. VI. Percentage of patients who do not present asymptomatic bacteriuria throughout the treatment. VII. Presence of urinary tract symptoms and signs at the baseline visit, weeks 3, 12, 18, 24 and visits by UTI. VIII. Determination of vaginal pH at baseline and variation with respect to the baseline visit at weeks 3, 12, 18 and 24. IX. Record of adverse events according to the Medical Dictionary for Regulatory Activities (MedDRA). X. Tolerability of treatment in weeks 3, 12, 18 and 24. XI. Acceptability of the treatment in week 24.;Timepoint(s) of evaluation of this end point: Please refer to the timepoint specified in each variable | — |
Countries
Spain
Contacts
Public ContactSyra Velasco Ortega
ITF RESEARCH PHARMA S.L.U.
Outcome results
None listed