Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action

Study Overview
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Brief Summary
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This clinical investigation will look at the effectiveness and safety of two personal lubricants for the relief of intimate discomfort associated with vaginal dryness.

Detailed Description
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This is an open label, two-arm, parallel-design clinical investigation determining the effectiveness and safety of two personal lubricants. This clinical investigation consists of two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter the Tolerance Phase followed by the Treatment Phase. The remaining subjects will enter the Treatment Phase only.

Official Title
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A Two-arm, Parallel-design, Clinical Investigation to Determine the Effectiveness and Safety of a Water-based Personal Lubricant With a Sensory Action and Silicone-based Personal Lubricant With a Sensory Action for the Relief of Intimate Discomfort Associated With Vaginal Dryness

Conditions
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Dyspareunia, Vaginal Dryness

Intervention / Treatment
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* Device: Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)
* Device: Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has provided written informed consent. Subject is aged at least 18 years. Subject in a mutually monogamous heterosexual relationship (≥3 months) who is sexually active, defined as having sexual intercourse at least once a week. Female subject that 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. Female subject that agrees to an oral exam by a dermatologist to ensure no significant disease findings and have intact skin and mucous in the test region. Subjects reporting mild to moderate vaginal dryness and dyspareunia during sex (when not using lubricant) in the past 3 months as confirmed on the Verbal Rating Scale (VRS). Pre-menopausal Inclusion Criteria: Female subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation. Post-menopausal Inclusion Criteria: Female subject in post-menopausal phase defined as having amenorrhea (absence of menstruation) for at least 12 months. Post-menopausal Inclusion Criteria: Female subject with premature menopause - surgical menopause or physiological menopause within the last 12 months or after having received chemotherapy. Exclusion Criteria: Subject who has previously experienced an irritant or allergic reaction to any personal lubricant, vaginal moisturiser or female hygiene product or known to have any contact allergen or allergy/hypersensitivity to the test product ingredients. Female subject with history of mucosal intolerance to warming agents. Female subject with continuous or intermittent oral allergy syndrome or burning mouth syndrome of history of thereof. Female subject with urinary, vaginal infection (fungal, bacterial) or sexually transmitted infection which may affect the study outcomes or the safety of the subject. Female subject that has any condition of the oral cavity as determined by the investigator. Male subject has broken skin or wounds in the intimate area. Female subject with a history of skin disorder, which in the opinion of the investigation will affect study outcome. Female subject with autoimmune conditions or any medical conditions which in the opinion of the investigator could compromise the immune function. Female subject who has used any kind of topical histamine and/or topical hormonal based product in the form of an intravaginal cream or moisturiser for local treatment of vaginal dryness in the past 3 months. Female subject using non-medicated, over the counter product, herbal/natural remedies on the vulva, vaginal opening and inside the vagina and is unwilling to stop at least 7 days prior to screening and throughout the duration of clinical investigation. Female subject showing vaginal prolapse and/or other medical conditions that could interfere with the investigation conduct and participation. Female subject who has had surgical cervical excision or vaginal and/or vulvar procedures, including laser and cosmetic procedures to the vulva or vagina in the previous year. Pre-menopausal Exclusion Criteria: Female subject who is pregnant (as confirmed by a positive pregnancy test), breast-feeding or trying to conceive. Post-Menopausal Exclusion Criteria: Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The personal lubricants will be tested in a 2-arm parallel-design, where subjects will be randomised to an arm/lubricant. Subjects participating in the both the tolerance and treatment phases will be enrolled into an arm for each which includes the same IP/lubricant throughout both phases.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricant A and Comparator A<br>The comparator will be tested for oral assessment in the tolerance phase only. Tolerance phase includes oral assessment and vaginal assessment. A 7-Day wash-out period followed by 2 visits. Visit 1 will include baseline assessments and application of allocated IP. Visit 2 will consist of clinical assessment. This is conducted on a sub-set of the population enrolled into the arm using the same IP for the treatment phase. Treatment phase includes a 4-week run-in period followed by 2 visits. Visit 1 will include baseline assessments and provision of allocated IP. Visit 2 will consist of clinical assessment. | Device: Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)<br>* In the tolerance phase, a pea-sized lubricant will be considered a single application for oral assessment and approximately 3g of lubricant will be considered a single application for vaginal assessment. In the treatment phase, approximately 3g of lubricant will be considered a single application.<br>|
| Experimental: Lubricant B and Comparator B<br>The comparator will be tested for oral assessment in the tolerance phase only. Tolerance phase includes oral assessment and vaginal assessment. A 7-Day wash-out period followed by 2 visits. Visit 1 will include baseline assessments and application of allocated IP. Visit 2 will consist of clinical assessment. This is conducted on a sub-set of the population enrolled into the arm using the same IP for the treatment phase. Treatment phase includes a 4-week run-in period followed by 2 visits. Visit 1 will include baseline assessments and provision of allocated IP. Visit 2 will consist of clinical assessment. | Device: Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)<br>* In the tolerance phase, a pea-sized lubricant will be considered a single application for oral assessment and approximately 3g of lubricant will be considered a single application for vaginal assessment. In the treatment phase, approximately 3g of lubricant will be considered a single application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Female Sexual Function Index (FSFI) score compared to baseline | The change in FSFI from the baseline event and at 4-weeks post baseline | 4 weeks after baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Female Sexual Function Index (FSFI) individual domain scores | Change from baseline in the FSFI individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain) at 4-weeks post baseline | 4 weeks after baseline | 
| Subject perception of the personal lubricants through Subject Perceived Questions | Subjects' perception of each of the two personal lubricants will be determined through Subject Perceived Questions | Initial application (within 24 hours of intercourse) and after 4 weeks | 
| The evaluation of Product Effectiveness, Tolerability and Usability (subjective opinion) | Subjects will rate their evaluation of Product Effectiveness, Tolerability and Usability after IP use using the following scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Very Dissatisfied | 4 weeks after baseline | 
| The impression of change in the sexual intimacy (subjective opinion) | Subjects' evaluation of improvement in sexual intimacy will be determined through the Patient Global Impression of Change (PGIC) questionnaire which is presented in a form of the visual analogue scale: -3 (much worse), -2, -1, 0 (no change), 1, 2, 3 (much better) | 4 weeks after baseline | 
| The assessment of the Vaginal Epithelial Tolerability (VET) | The gynaecolosit will make an assessment of the VET based on the vaginal dermal tissue for signs and symptoms of erythema, oedema, vulvar membrane dryness, leucorrhoea by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe) | Baseline, 2 and 24 hours post single application | 
| Tolerability as assessed by Subject Perceived Questions | Tolerability of the two personal lubricants will be determined through Subject Perceived Questions | 24 hours post single application | 
| The assessment of overall tolerance for each subject | The gynaecologist and dermatologist will make an assessment of tolerance of each subject for each IP based on measured parameters, any clinical signs of irritancy observed and subject's perception of vulvovaginal and oral mucosal tolerance by using the 5-point scale: very good, good, acceptable, poor, very poor | 24 hours post single application | 
| Overall Tolerance Rating Statement for each lubricant by gynaecologist and by dermatologist | An overall summary statement of tolerance of each lubricant will be made by gynaecologist and by dermatologist, taking into consideration all tolerance assessments across all subjects | 24 hours post single application | 
| The assessment of oral mucosal tolerance | The dermatologist will make an assessment of oral mucosal tolerance based on the signs and symptoms of erythema, erosions, oedema and any other signs of clinical irritancy by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe) | Baseline, 30 minutes, 2 hours and 24 hours post single application | 
| Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) | Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per subject. | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaginal lubricant