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Primary: Evaluation of improved vaginal moisture in postmenopausal women.
Secondary: the improvement of symptoms resulting from the dryness Rating (VHI), evaluation of the decrease in vaginal pH, assessment of Sexual Function Index female (FSFI), evaluation of adherence to study treatment by patient diary, assessing the acceptability of the product and subjective assessment of the patient as the itching and stinging / burning, beyond the safety assessment.
ENDPOINT:
STUDY DESING: Phase IV study, longitudinal, prospective, open label, non-comparative
POPULATION: Forty-six (46) post menopausal women with vaginal dryness
DRUG: Polimers and Sodium Lactate
TREATMENT: Only treatment - two weekly applications (monday and thursday or tuesday and friday) for 12 weeks
EVALUATION: The evaluation of the effectiveness will be held on all visits by medical clinical evaluation, evaluation of symptoms resulting from the dryness (VHI), pH evaluation (pH tape) and evaluation of female sexual quality (FSFI) and subjective evaluation as well as the compliance through the patient diary. The evaluation of the acceptability of the product will be the last visit by a questionnaire. The safety assessment will be carried out on all visits by identifying adverse events
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Only treatment | Experimental | two weekly applications (monday and thursday or tuesday and friday) for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hidra1 | Drug | Parameters: Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none / inflamed area ; 2 = no / NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal. Will be described through the Media and Standard Deviation or median and interquartile rank , as Minimum and Maximum. Scala: pH tape: It will be measured by its own value. Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of improved vaginal moisture in post menopausal women by the Vaginal health index (VHI). | Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none / inflamed area ; 2 = no / NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal | 4 months |
| Scala: pH tape: It will be measured by its own value. | 4 months | |
| Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient. | 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Verify the tolerability and safety by identifying adverse events | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fabiene Vale, Physician | Contact | 55 31 91878133 | fabienebcv@yahoo.com.br |
| Name | Affiliation | Role |
|---|---|---|
| Thales Braga, Analist | Famorquimica SA | Study Chair |
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