CompletedNot Applicable

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

Germany132 participantsStarted 2023-02-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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.

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.

What they're measuring

Female Sexual Function Index (FSFI) Score Compared to Baseline

Timeframe: 4 weeks after baseline

Trial details

NCT IDNCT05644444

SponsorReckitt Benckiser Healthcare (UK) Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-05-05

Results submitted2024-08-28

View on ClinicalTrials.gov More Dyspareunia trials