A Clinical Investigation Into the Effectiveness and Safety of Five Water Based Personal Lubricants.

This is an open label, five-arm, parallel-design clinical investigation determining the effectiveness and safety of five personal lubricants. This clinical investigation consists of two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter both 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 female and aged: 18 years to 65 years.
• Female 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 of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
• 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.
• 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).

Post-menopausal Inclusion Criteria:

• Female subject in post-menopausal phase defined as having amenorrhea (absence of menstruation) for at least 12 months.
• Female subject with premature menopause - surgical menopause or physiological menopause within the last 12 months or after having received chemotherapy.

Exclusion criteria

• Female subject who is pregnant, breast-feeding or trying to conceive.
• Female subject who has previously experienced an irritant or allergic reaction to any personal lubricant, vaginal moisturiser or female hygiene product or known to suffer from any contact allergen and/or are allergic to the investigational product ingredients.
• Female subject has urinary, vaginal infection (fungal, bacterial) or sexually transmitted infection as diagnosed by the investigator.
• Female subject presenting signs of internal irritation, active psoriasis, eczema or other active skin disorder or with a history of skin disorder
• Female subject presenting clinically abnormal findings other than irritation during the physical examination that will affect study outcome.
• Female subject who has started, stopped or changed hormonal treatments (including contraceptives) during the previous 3 months prior to screening.
• Female subject who has used any kind of topical histamine and/or topical hormonal based product for local treatment of vaginal dryness in the past 3 months.
• Female subject with any medical conditions which in the opinion of the investigator could compromise the immune function.
• Female subject taking steroid preparations, immune-suppressive drugs or any other medication which in the opinion of the investigator may affect the test results.
• Female subject who has had any change to medication or treatment regimen for the treatment of diabetes mellitus during the previous 3 months prior to screening.
• Female subject that will be unable to comply fully with the study requirements or unable to tolerate the procedures.
• Female subject that have had a suspicion of malignancy or history of malignancy within the past 2 years.
• Female subject who has had surgical cervical excision or vaginal and/or vulvar procedures in the previous year.
• Female subject that has had a positive cervical screening examination for Human Papillomavirus (HPV) within the 3 years of the screening visit.
• Female subject currently being treated with systemic medications or medicines that act locally in the vaginal area.
• Female subject using vaginal douches and is unwilling to stop its use at least 2 weeks prior to screening and throughout the clinical investigation.
• Female subject has changed contraceptive medication within the past 3 months or intending to change contraceptive medications.
• Female subject has participated in another investigation within 3 months prior to screening.
• Subject who is an employee at the site or a partner or first-degree relative of the Investigator.
• Subject fails to satisfy the investigator of fitness to participate for any other reason.

Post-Menopausal Exclusion Criteria:

• Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
• Female subject showing vaginal prolapse and/or other medical conditions that could interfere with the study conduct and participation.
• Female subject that have used any kind of systemic and/or local hormonal products for the treatment of vaginal dryness or any other vaginal condition in the 3 months prior to screening.