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

Not Applicable

Completed

Conditions: Vaginal Dryness
Dyspareunia

Interventions: Device: Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)
Device: Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)

Registration Number: NCT05644444

Lead Sponsor: Reckitt Benckiser Healthcare (UK) Limited

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 132

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lubricant B and Comparator B	Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)	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.
Lubricant A and Comparator A	Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)	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.

Primary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI) Score Compared to Baseline	4 weeks after baseline	The change in FSFI from the baseline event and at 4-weeks post baseline. The FSFI is a 19-item self-report questionnaire to measure sexual functioning in women. The questionnaire assesses six domains of sexual function (sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain) and provides a total score for sexual function. For individual domain scores, add the scores of the individual questions that comprise the domain and multiply the sum by the domain factor. Add the six domain scores to obtain the total FSFI score. The range of total score is 2.0-36.0. Higher value represents a higher level of sexual function. This measure is the change in total FSFI score between baseline and end of treatment phase (4 weeks).

Secondary Outcome Measures

Name	Time	Method
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion)	4 weeks after baseline	Participants rated 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.
Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores	4 weeks after baseline	Change from baseline in the FSFI individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain) at 4-weeks post baseline For individual FSFI domain scores, add the scores of the individual questions that comprise the domain and multiply the sum by the domain factor. The range of each score is: Desire 1.2-6.0, Arousal 0-6.0, Lubrication 0-6.0, Orgasm 0-6.0, Satisfaction 0.8-6.0 and Pain 0-6.0. Higher value represents a higher level of individual sexual function. This measure is the change in individual FSFI score between baseline and end of treatment phase (4 weeks).
Subject Perception of the Personal Lubricants Through Subject Perceived Questions	Initial application (within 24 hours of intercourse) and after 4 weeks	Subjects' perception of each of the two personal lubricants will be determined through Subject Perceived Questions. Participants ranked a statement (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree) that best described the experience. Answering options "agree/strongly agree" were combined to the category 'agreement'.
The Impression of Change in the Sexual Intimacy (Subjective Opinion)	4 weeks after baseline	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)
The Assessment of the Vaginal Epithelial Tolerability (VET)	Baseline, 2 and 24 hours post single application	The gynaecologist made 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)
Tolerability as Assessed by Subject Perceived Questions	24 hours post single application	Tolerability of the two personal lubricants was determined through Subject Perceived Questions. Participants ranked a statement (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree) that best described the experience. Answering options "agree/strongly agree" were combined to the category 'agreement'.
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs)	10 weeks	Overall proportion of participants with Adverse Events/Adverse Device Effects (AEs/ADEs) i.e. the occurrence of one of more AE/ADE per participant.
The Assessment of Overall Tolerance for Each Participant	24 hours post single application	The gynaecologist and dermatologist made 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.
The Assessment of Oral Mucosal Tolerance	Baseline, 30 minutes, 2 hours and 24 hours post application	The dermatologist made 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).