Ignite Creation Date:
2024-05-06 @ 7:38 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02571127
Status:
UNKNOWN
Last Update Posted:
2015-10-08
First Post:
2015-09-01
Brief Title:
Evaluate the Efficacy Safety and Tolerability of a Non-hormonal Intravaginal Gel in Postmenopausal Women With Symptoms of Vaginal Dryness
Sponsor:
Farmoquimica SA
Organization:
Farmoquimica SA
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2015-09
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients 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
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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None