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

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.

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.