NCT02571127

Evaluate the Efficacy, Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness.

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.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 46 (estimated)
• Sponsor: Farmoquimica S.A. · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Vaginal Atrophy

Interventions

Type	Name	Description
DRUG	Hidra1	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.

Timeline

• Start date: 2015-10-01
• Primary completion: 2016-02-01
• Completion: 2016-03-01
• First posted: 2015-10-08
• Last updated: 2015-10-08