Clinical trial NCT05738733: A Clinical Efficacy Study of MsChief Personal Lubricant in Healthy Female Subjects
Official title: A Proof of Science, In-Use Tolerance, Safety, and Efficacy Clinical Study of MsChief Personal Lubricant in Healthy Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Females
Lead sponsor: NovoBliss Research Pvt Ltd
Sponsor class: OTHER
Collaborators: name: TTK Healthcare Ltd - Protective Devices Division
First posted: 2023-02-22
Enrollment: 138
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A proof-of-science, open-label, single-centre, four-arm, In-Use tolerance, safety, efficacy clinical study
Primary purpose: PREVENTION

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.

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

Eligibility criteria: Inclusion Criteria:

1. Age: 18 to 65 years (both inclusive) at the time of consent.
2. Sex: Healthy non-pregnant/non-lactating females

   * Females of fertile reproductive age with a propensity to vulvo-vaginal infection (18 years to 40 years)
   * Females in the pre-menopausal age group (41 years to 48 years)
   * Females in the post-menopausal age group (49 years to 65 years)
3. The subject is with Nugent score ≤3.
4. The subject with an active sex life of at least 01 sexual intercourse in a week
5. The subject of childbearing potential must have a reported negative pregnancy during screening and the end of the study.
6. The subject without a history of sensitivity to similar products/formulations
7. The subject is willing to give written informed consent and is willing to follow the study procedures.
8. The subject is willing to abide by the study protocol and study restrictions including abstinence from the use of any other product besides the test product for intimate wash, lubricant or any other products during the study.
9. The subject is a personal lubricant user and agrees to replace her usual personal lubricant with the test product.
10. The subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
11. The subject is of childbearing potential, is practising and agrees to maintain an established method of birth control (IUD, hormonal implant device/injection, regular use of birth control pills or patch, diaphragm, condoms, partner vasectomy or abstinence). Females will be considered as non-childbearing potential if they are surgically sterile, have been post-menopausal for at least 1 year or have had a tubal ligation.
12. If currently using hormonal contraception, has been using this form of contraception for at least 6 months and agrees to continue using the same contraception for the duration of the study.
13. The subject who agrees to have a gynaecological pelvic examination to ensure no significant disease findings and have intact skin and mucous in the test region assessed by the gynaecologist at all the relevant time points

Exclusion Criteria:

1. The subject used other intra-vaginal gel moisturizers during the study.
2. The subject with Nugent score \>3.
3. The subject who is diagnosed with cancer
4. The subject using hormone replacement therapy for the last 3 months
5. The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections or urinary tract infections.
6. Pregnant or lactating, women who are likely to become pregnant.
7. The subject exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation.
8. Personal history of allergy and hypersensitivity to any product of feminine hygiene, severe systemic complications of viral infections, severe systemic illness like cardiovascular disorders, neurological disorders, renal disorders, and autoimmune disorders.
9. The subject with any form of chronic infection/ allergy/ disease which may influence the study result
10. The subject with bacterial vaginosis/candidiasis/mycotic infections
11. The subject participated in clinical studies or had received any investigational agent in the previous 30 days.
12. The subject is not willing to sign an informed consent form.
13. The subject is an employee at the site or a partner or first-degree relative of the Investigator.
14. The subject fails to satisfy the Investigator of fitness to participate for any other reason.
15. The subject has had previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
16. The subject showed vaginal prolapse and/or other medical conditions that could interfere with the study's conduct and participation.
17. The subject who has used any kind of systemic and/or local hormonal products for vaginal dryness or any other vaginal condition in the 3 months prior to screening

Primary outcomes:
measure: Change in vaginal local irritation
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
measure: Change in vaginal moisturizing effects
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
measure: Change in sexual intimacy
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
measure: Change in VAS score for vaginal itching
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
Secondary outcomes:
measure: Change in quality and odor of vaginal discharge
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
measure: Change in vaginal pH
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
measure: Change in clinical symptoms associated with infection
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
measure: Change in Nugents score
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
measure: Product perception and consumer feedback
timeFrame: From baseline i.e. Day 01 (before application) to Day 16 post usage
Other outcomes:
Locations:
city: Gandhinagar
country: India
facility: Krisha Hospital
state: Gujarat
Study officials:
affiliation: Medical Director
name: Dr Nayan K Patel, MBBS
role: PRINCIPAL_INVESTIGATOR
References: