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Healthy FemalesNCT05738733

A Clinical Efficacy Study of MsChief Personal Lubricant in Healthy Female Subjects

A study testing MsChief Classic Natural Lubricant, MsChief Ylang Ylang Natural Lubricant and MsChief Vanilla & Citrus Natural Lubricant in people with Healthy Females, run by NovoBliss Research Pvt Ltd at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthy Females
What is being tested?
MsChief Classic Natural Lubricant, MsChief Ylang Ylang Natural Lubricant and MsChief Vanilla & Citrus Natural Lubricant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
138 participants
Where
1 siteIndia
Study dates
2 Mar 2023to 30 May 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Age: 18 to 65 years (both inclusive) at the time of consent.
  • 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)
  • The subject is with Nugent score ≤3.
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  • The subject with an active sex life of at least 01 sexual intercourse in a week
  • The subject of childbearing potential must have a reported negative pregnancy during screening and the end of the study.
  • The subject without a history of sensitivity to similar products/formulations
  • The subject is willing to give written informed consent and is willing to follow the study procedures.
  • 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.
  • The subject is a personal lubricant user and agrees to replace her usual personal lubricant with the test product.
  • The subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
  • 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.
  • 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.
  • 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

Who cannot join

  • The subject used other intra-vaginal gel moisturizers during the study.
  • The subject with Nugent score >3.
  • The subject who is diagnosed with cancer
  • The subject using hormone replacement therapy for the last 3 months
  • The subject has a history or visible evidence of chronic skin disease or regional infections, genital herpes, vaginal infections or urinary tract infections.
  • Pregnant or lactating, women who are likely to become pregnant.
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  • The subject exhibits or reports gynecologic abnormalities or has had vaginitis within 60 days prior to study initiation.
  • 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.
  • The subject with any form of chronic infection/ allergy/ disease which may influence the study result
  • The subject with bacterial vaginosis/candidiasis/mycotic infections
  • The subject participated in clinical studies or had received any investigational agent in the previous 30 days.
  • The subject is not willing to sign an informed consent form.
  • The subject is an employee at the site or a partner or first-degree relative of the Investigator.
  • The subject fails to satisfy the Investigator of fitness to participate for any other reason.
  • The subject has had previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
  • The subject showed vaginal prolapse and/or other medical conditions that could interfere with the study's conduct and participation.
  • 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

Trial locations and contacts

1 site in 1 country.

India1 site

  • Krisha Hospital

    Gandhinagar, Gujarat, 382421

Other trials in India

About this study

Official title: A Proof of Science, In-Use Tolerance, Safety, and Efficacy Clinical Study of MsChief Personal Lubricant in Healthy Female Subjects

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.

Read the 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
  1. Subjective Self-assessments
  • Perceived irritations - Burning, Itching, Stinging, Discomfort
  • Sexual activity (where appropriate)
  • VAS Scoring for Vaginal itchiness
  • Quality of life assessment
  1. Microbiological Assessments • Nugents scoring
Conditions
Healthy Females
Being tested
MsChief Classic Natural Lubricant, MsChief Ylang Ylang Natural Lubricant, MsChief Vanilla & Citrus Natural Lubricant, MsChief Tea & Peach Natural Lubricant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MsChief Classic Natural LubricantDevice

    Apply the desire amount of lubricant on the body to make it more sensitive.

  • MsChief Ylang Ylang Natural LubricantDevice

    Apply the desire amount of lubricant on the body to make it more sensitive.

  • MsChief Vanilla & Citrus Natural LubricantDevice

    Apply the desire amount of lubricant on the body to make it more sensitive.

  • MsChief Tea & Peach Natural LubricantDevice

    Apply the desire amount of lubricant on the body to make it more sensitive.

Study groups in NCT05738733
Study groupRoleWhat they receive
MsChief Classic Natural LubricantExperimentalMsChief Classic natural lubricant contains aqua, propylene glycol, hydroxyethyl cellulose, ethyl menthane carboxamide and methyl diisopropyl propionamide, aloe barbadensis leaf juice, benzoic acid, hippophae Rhamnoides extract, tocophersolan, sodium hydroxide. MsChief Classic natural lubricant is a special moisturizer with aloe vera, vitamin E and sea buckthorn. It not only conditions but also moisturises the skin. This lubricant is water-based is free of sugar or saccharine. This product does not contain paraben or glycerine. This product has a unique formulation pH ideal for intimate area.
Receives: Device: MsChief Classic Natural Lubricant
MsChief Ylang Ylang Natural LubricantExperimentalMsChief Ylang Ylang natural lubricant contains aqua, propylene glycol, flavour, hydroxyethyl cellulose, ethyl menthane carboxamide and methyl diisopropyl propionamide, aloe barbadensis leaf juice, benzoic acid, hippophae Rhamnoides extract, tocophersolan, sodium hydroxide. MsChief Ylang Ylang natural lubricant is a special moisturizer with aloe vera, vitamin E and sea buckthorn It not only conditions but also moisturise the skin. This lubricant is water-based contain natural flavour and free of sugar or saccharine. This product does not contain paraben or glycerine. This product has a unique formulation pH ideal for intimate area.
Receives: Device: MsChief Ylang Ylang Natural Lubricant
MsChief Vanilla & Citrus Natural LubricantExperimentalMsChief vanilla and citrus natural lubricant contain aqua, propylene glycol, flavour, hydroxyethyl cellulose, ethyl menthane carboxamide and methyl diisopropyl propionamide, aloe barbadensis leaf juice, benzoic acid, hippophae Rhamnoides extract, tocophersolan, sodium hydroxide. MsChief vanilla and citrus natural lubricant is a special moisturizer with Aloe vera, vitamin E and sea buckthorn. It not only conditions but also moisturise the skin. This lubricant is water based contain natural flavour and free of sugar or saccharine. This product does not contain paraben or glycerine. This product has a unique formulation pH ideal for intimate area.
Receives: Device: MsChief Vanilla & Citrus Natural Lubricant
MsChief Tea & Peach Natural LubricantExperimentalMsChief tea \& peach natural lubricant contains aqua, propylene glycol, flavour, hydroxyethyl cellulose, ethyl menthane carboxamide and methyl diisopropyl propionamide, aloe barbadensis leaf juice, benzoic acid, hippophae Rhamnoides extract, tocophersolan, sodium hydroxide. MsChief tea \& peach natural lubricant is a special moisturizer with Aloe vera, vitamin E and sea buckthorn. It not only conditions but also moisturises the skin. This lubricant is water-based contains natural flavour and is free of sugar or saccharine. This product does not contain paraben or glycerine. This product has a unique formulation pH ideal for intimate area.
Receives: Device: MsChief Tea & Peach Natural Lubricant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in vaginal local irritation

    To assess the test product(s) effectiveness in terms of change in vaginal local irritation by the Gynecologist using 4-point scale[0=absent, 1=mild, 2=moderate, 3=severe]..

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

  2. Change in vaginal moisturizing effects

    To assess the test product(s) effectiveness in terms of change in vaginal moisturizing effects as evaluated by the Gynecologist using Modified Schemer Test

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

  3. Change in sexual intimacy

    To assess the test product(s) effectiveness in terms of change in sexual intimacy using female sexual function index self-reported scale score [score of zero indicates that the subject reported having no sexual activity during the past 15 days].

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

  4. Change in VAS score for vaginal itching

    To assess the test product(s) effectiveness in terms of change in Visual Analog Score score for vaginal itching as evaluated by the Gynecologist [ 0 points - No itchiness, greater than or equal to 9 points: Very severe Itchiness

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

Secondary outcomes (5)

  1. Change in quality and odor of vaginal discharge

    To assess the test product(s) effectiveness in terms of change in quality and odor of vaginal discharge as evaluated by the Gynecologist using vaginal odour score [0=absent, 1=mild, 2=moderate, 3=intense, 4=very intense].

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

  2. Change in vaginal pH

    To assess the test product(s) effectiveness in terms of change in vaginal pH as evaluated by the Gynecologist using pH paper

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

  3. Change in clinical symptoms associated with infection

    To assess the test product(s) effectiveness in terms of change in clinical symptoms associated with infection i.e. redness, itching, burning sensation, swelling of vaginal vulva, vaginal rash as evaluated by the Gynecologist using 4-point scale [0=absent, 1=mild, 2=moderate, 3=severe].

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

  4. Change in Nugents score

    To assess the test product(s) effectiveness for change in Nugents score for microbial assessment [0-3: Normal, 4-6: Intermediate bacterial count, 7-10: Bacterial vaginosis].

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

  5. Product perception and consumer feedback

    To assess the effect of the test product(s) assessed in terms of product perception and consumer feedback using 9 point hedonic scoring scale

    Measured: From baseline i.e. Day 01 (before application) to Day 16 post usage

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2023
  2. Study start2 Mar 2023
  3. Primary completion22 Apr 2023
  4. Study completion30 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
A proof-of-science, open-label, single-centre, four-arm, In-Use tolerance, safety, efficacy clinical study
Masking
None (open label)
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05738733
Sponsor's protocol ID
NB230002-TT
Status last verified
Jul 2023
First submitted
31 Jan 2023
Last updated
10 Jul 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing MsChief Classic Natural Lubricant, MsChief Ylang Ylang Natural Lubricant and MsChief Vanilla & Citrus Natural Lubricant in people with Healthy Females, run by NovoBliss Research Pvt Ltd at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in vaginal local irritation (time frame: From baseline i.e. Day 01 (before application) to Day 16 post usage). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05738733.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2023.

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