Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01948583
Status:
COMPLETED
Last Update Posted:
2013-09-23
First Post:
2013-09-06
Brief Title:
Humectant Activity of a New Formulation of Gynomunal Vaginalgel
Sponsor:
Derming SRL
Organization:
Derming SRL
Study Overview
Official Title:
Humectant Activity of a New Formulation of Gynomunal Vaginalgel Crossover Test Use Versus Previous Formula
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
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:
GYNOMUNAL
Brief Summary:
Aim of the study is to evaluate the humectant activity and the local tolerability of a new formulation of Gynomunal vaginalgel in menopausal women menopause since at least 2 years with referred vaginal dryness
Detailed Description:
Randomized controlled crossover clinical study the subjects will use both formulations with an interval of 1 week wash out period in reversed sequence according to the treatment arm assigned at each subject during the basal visit
Both tested products will be applied in the vagina using the dedicated applicator once a day preferably at bedtime To investigate the activity of the products under study 4 visits will be performed a baseline visit T0 a visit at the end of the first week-treatment T1 a visit at the end of the wash out period T2 and a final visit at the end of the second week-treatment T3
Volunteers will be asked to follow their normal life and sexual habits except for not having sexual intercourse 48 hours prior to each examination
Both tested products will be applied in the vagina using the dedicated applicator once a day preferably at bedtime To investigate the activity of the products under study 4 visits will be performed a baseline visit T0 a visit at the end of the first week-treatment T1 a visit at the end of the wash out period T2 and a final visit at the end of the second week-treatment T3
Volunteers will be asked to follow their normal life and sexual habits except for not having sexual intercourse 48 hours prior to each examination
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