Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2026-02-12 @ 5:20 PM
Study NCT ID:
NCT03782961
Status:
UNKNOWN
Last Update Posted:
2018-12-21
First Post:
2018-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Viscosity of a Vaginal Moisturizer
Sponsor:
Farmoquimica S.A.
Organization:
Study Overview
Official Title:
Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women
Status:
UNKNOWN
Status Verified Date:
2018-12
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:
To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women
Detailed Description:
A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.
It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.
The participant will remain in the study for one day, making use of the research product in the Research Center.
Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.
Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.
A gynecologist will be available to monitor the participants throughout the study.
It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.
The participant will remain in the study for one day, making use of the research product in the Research Center.
Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.
Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.
A gynecologist will be available to monitor the participants throughout the study.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: