Vaginal Atrophy Clinical Trial
Official title:
Ph IV , Longitudinal, Prospective, Open Label, Non-comparative, to Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.
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:
- Primary: Evaluation of improved vaginal moisture in post menopausal women through
vaginal health index (VHI);
- Secondaryevaluate the increase in fluid volume, vaginal elasticity and integrity of the
epithelium by the VHI, evaluate the pH control, improvement of female sexual quality by
applying the Sexual Function Index female (FSFI), evaluate through the patient's daily
treatment adherence, evaluate the acceptability (welfare, run-off and satisfaction) of
the product and the improvement of itching and stinging / burning through
questionnaires and verify the tolerability and safety by identifying adverse events.
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
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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