Ignite Creation Date:
2024-05-06 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05738733
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2023-01-31
Brief Title:
A Clinical Efficacy Study of MsChief Personal Lubricant in Healthy Female Subjects
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
NovoBliss Research Pvt Ltd
Study Overview
Official Title:
A Proof of Science In-Use Tolerance Safety and Efficacy Clinical Study of MsChief Personal Lubricant in Healthy Female Subjects
Status:
COMPLETED
Status Verified Date:
2023-07
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:
None
Brief Summary:
A Proof of Science Open-Label Single Centre Four-Arm In-Use Tolerance Safety and Efficacy Clinical Study of MsChief Personal Lubricant in Healthy Female Subjects
30 subjectsproduct 33 subjects enrolmenttreatment healthy non-pregnantnon-lactating females with an age of 18 - 65 years old
A total of up to 132 subjects 33 subjectsproduct will be enrolled to get 120 completed subjects 30 subjectsproduct in the study
30 subjectsproduct 33 subjects enrolmenttreatment healthy non-pregnantnon-lactating females with an age of 18 - 65 years old
A total of up to 132 subjects 33 subjectsproduct will be enrolled to get 120 completed subjects 30 subjectsproduct in the study
Detailed Description:
A sufficient number of healthy female subjects with an age group of 18 - 65 years old with a Nugent score 3 will be recruitedenrolled
The potential subjects will be screened as per the inclusion exclusion criteria only after obtaining written informed consent from the subjects The subjects will be instructed to visit the facility as per the below visits
Visit 01 Within 07 Days Screening Baseline evaluations
Visit 02 Day 01 Enrolment Test Products usage phase start
Visit 03 Day 16 Test Products usage ends End of the study Subjects will be pre-screened by the screening department of NovoBliss Research Subjects will be telephonically contacted by recruiting department prior to the enrolment visit Subjects will be instructed during screening prior to enrolment not to use any other product for intimate washes lubricant or any other product during the study
Assessment of efficacy parameters will be done before test products usage on Day 1 and will be compared with after test products usage during Day 16 as listed below
1 Gynaecological Assessments
Local irritation pruritus erythema edema
Moisturizing effect - moisture dryness flaking epithelial mucosa
Quality and odour of vaginal discharge
Vaginal pH measure using pH paper
Clinical symptoms associated with infections
Verbal rating scale 0-4 score- Vaginal itching
2 Subjective Self-assessments
Perceived irritations - Burning Itching Stinging Discomfort
Sexual activity where appropriate
VAS Scoring for Vaginal itchiness
Quality of life assessment
3 Microbiological Assessments Nugents scoring
The potential subjects will be screened as per the inclusion exclusion criteria only after obtaining written informed consent from the subjects The subjects will be instructed to visit the facility as per the below visits
Visit 01 Within 07 Days Screening Baseline evaluations
Visit 02 Day 01 Enrolment Test Products usage phase start
Visit 03 Day 16 Test Products usage ends End of the study Subjects will be pre-screened by the screening department of NovoBliss Research Subjects will be telephonically contacted by recruiting department prior to the enrolment visit Subjects will be instructed during screening prior to enrolment not to use any other product for intimate washes lubricant or any other product during the study
Assessment of efficacy parameters will be done before test products usage on Day 1 and will be compared with after test products usage during Day 16 as listed below
1 Gynaecological Assessments
Local irritation pruritus erythema edema
Moisturizing effect - moisture dryness flaking epithelial mucosa
Quality and odour of vaginal discharge
Vaginal pH measure using pH paper
Clinical symptoms associated with infections
Verbal rating scale 0-4 score- Vaginal itching
2 Subjective Self-assessments
Perceived irritations - Burning Itching Stinging Discomfort
Sexual activity where appropriate
VAS Scoring for Vaginal itchiness
Quality of life assessment
3 Microbiological Assessments Nugents scoring
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?:
None