Ignite Creation Date:
2025-12-25 @ 2:51 AM
Ignite Modification Date:
2026-02-09 @ 1:59 AM
Study NCT ID:
NCT05738733
Status:
COMPLETED
Last Update Posted:
2023-07-10
First Post:
2023-01-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Efficacy Study of MsChief Personal Lubricant in Healthy Female Subjects
Sponsor:
NovoBliss Research Pvt Ltd
Organization:
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 subjects/product (33 subjects' enrolment/treatment) healthy non-pregnant/non-lactating females with an age of 18 - 65 years old.
A total of up to 132 subjects (33 subjects/product) will be enrolled to get 120 completed subjects (30 subjects/product) in the study.
30 subjects/product (33 subjects' enrolment/treatment) healthy non-pregnant/non-lactating females with an age of 18 - 65 years old.
A total of up to 132 subjects (33 subjects/product) will be enrolled to get 120 completed subjects (30 subjects/product) 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 recruited/enrolled.
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:
False
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?: