E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Recurrent Urinary Tract Infection (UTI) in postmenopausal women with vaginal atrophy. |
Infección del Tracto Urinario (ITU) recurrente en mujeres postmenopáusicas con atrofia vaginal. |
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E.1.1.1 | Medical condition in easily understood language |
Recurrent Urinary Tract Infection (UTI). |
Infección del Tracto Urinario (ITU) recurrente. |
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E.1.1.2 | Therapeutic area | Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10038140 |
E.1.2 | Term | Recurrent urinary tract infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
Evaluar la eficacia del gel vaginal de estriol al 0,005% para prevenir las infecciones del tracto urinario en mujeres postmenopáusicas con atrofia vaginal e infecciones urinarias de repetición. |
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E.2.2 | Secondary objectives of the trial |
- 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. |
- Evaluar el efecto del gel vaginal de estriol al 0,005% sobre la presencia de bacteriuria asintomática en mujeres postmenopáusicas con infecciones urinarias de repetición. - Evaluar el efecto del gel vaginal de estriol al 0,005% sobre los diferentes síntomas y signos urinarios, y sobre el pH vaginal en mujeres postmenopáusicas con infecciones urinarias de repetición. - Evaluar la seguridad y la tolerabilidad del gel vaginal de estriol al 0,005% en mujeres postmenopáusicas con infecciones urinarias de repetición. - Evaluar la aceptabilidad del gel vaginal de estriol al 0,005% en mujeres postmenopáusicas con infecciones urinarias de repetición. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
1. Mujeres de entre 55 y 75 años. 2. Mujeres postmenopáusicas (que lleven como mínimo 12 meses sin tener la menstruación) por proceso natural o por intervención quirúrgica. 3. Mujeres con sequedad vaginal. 4. Mujeres con un histórico de episodios de ITUs sintomáticas de: 4a) al menos 3 episodios de ITUs en los últimos 12 meses ó 4b) al menos 2 episodios de ITUs en los últimos 6 meses. |
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E.4 | Principal 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. |
1. Mujeres con presencia de infección urinaria sintomática confirmada microbiológicamente por urocultivo de la muestra tomada en visita de selección. 2. Mujeres con bacteriuria asintomática determinada por urocultivo de la muestra tomada en la visita de selección. 3. Mujeres con antecedentes de lesiones malignas o premalignas en mama o endometrio, tumores malignos de colon o hepáticos, melanoma maligno, trastornos tromboembólicos venosos (trombosis venosa profunda, embolia pulmonar) o trastornos tromboembólicos arteriales (isquemia cardiaca, infarto de miocardio, accidente cerebrovascular), enfermedad arterial periférica, trombosis de la arteria mesentérica, trombosis de la arteria renal o coagulopatías. 4. Mujeres con sangrado vaginal de etiología desconocida. 5. Mujeres que hayan recibido cualquier tipo de tratamiento vulvovaginal en los 15 días previos al inicio del tratamiento de estudio (visita basal). 6. Mujeres que hayan recibido fitoestrógenos en el transcurso de 1 mes antes del inicio del tratamiento de estudio (visita basal), incluida la administración vía vaginal. 7. Mujeres que hayan recibido terapia hormonal en los 3 meses antes del inicio del tratamiento de estudio (visita basal), incluida la administración de estrógenos vía vaginal. 8. Mujeres que estén en tratamiento con estrógenos o progestágenos, tibolona o moduladores selectivos del receptor de estrógenos, antiepilépticos y antisépticos urinarios. 9. Mujeres que hayan recibido tratamiento antibiótico de larga duración (durante dos o más semanas) en los últimos 3 meses antes del inicio del tratamiento de estudio. 10. Mujeres con lesiones anatómicas o funcionales del tracto urogenital. 11. Mujeres con catéter urinario permanente. 12. Mujeres diagnosticadas de diabetes mellitus. 13. Mujeres diagnosticadas de insuficiencia renal o hepática severa. 14. Mujeres con patologías neurológicas. 15. Mujeres inmunodeprimidas. 16. Mujeres con reflujo vesicouretral. 17. Mujeres con incontinencia urinaria por vejiga hiperactiva. 18. Mujeres que participan o han participado en los últimos 3 meses en otro ensayo clínico. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Number of episodes of urinary tract infection at the end of treatment (week 24). |
Número de episodios de infección del tracto urinario al final del tratamiento (semana 24). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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. |
I. Número de episodios de infecciones del tracto urinario ocurridas en las primeras 3, 12 y 18 semanas. II. Porcentaje de pacientes que no experimenta una recurrencia a lo largo del tratamiento. III. Tiempo hasta la primera recurrencia. IV. Días de tratamiento antibiótico. V. Número de episodios de bacteriuria asintomática registradas en las primeras 3, 12, 18 y 24 semanas. VI. Porcentaje de pacientes que no presenta bacteriuria asintomática a lo largo del tratamiento. VII. Presencia de síntomas y signos del tracto urinario en la visita basal, en las semanas 3, 12,18, 24 y en las visitas por ITU. VIII. Determinación del pH vaginal en la visita basal y variación respecto de la visita basal en las semanas 3, 12, 18 y 24. IX. Registro de acontecimientos adversos según el Diccionario Médico para Actividades Regulatorias (MedDRA). X. Tolerabilidad del tratamiento en las semanas 3, 12, 18 y 24. XI. Aceptabilidad del tratamiento en la semana 24. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Please refer to the timepoint specified in each variable |
Por favor referirse al tiempo especificado en cada variable. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 22 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS (including safety phone call that takes place 4 weeks after the final visit on week 24) |
LPLV (incluida la llamada telefónica de seguridad que se realizará 4 semanas después de la visita final en la semana 24) |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 13 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 13 |