A Phase 4 interventional study of Hidra1 in Vaginal Atrophy, sponsored by Farmoquimica S.A.. Status unknown. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2015-10-08.
Sponsored by Farmoquimica S.A. · Phase 4, Interventional, and Treatment
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
828 studies on the registry are indexed under Atrophy; 122 are open to participants now.
This study's planned enrollment of 46 is above the median of 34 across 603 interventional studies indexed under Atrophy.
Browse Atrophy studies →Farmoquimica S.A. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
two weekly applications (monday and thursday or tuesday and friday) for 12 weeks
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.
Also known as: Parameters: Vaginal health index (VHI), Scala: pH tape, Questionnaire: Sexual Function Index female (FSFI)
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
Time frame: 4 months
Scala: pH tape: It will be measured by its own value.
Time frame: 4 months
Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient.
Time frame: 4 months
Verify the tolerability and safety by identifying adverse events
Time frame: 4 months
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.
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Farmoquimica S.A.