Clinical trial NCT05644444: Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyspareunia
Vaginal Dryness
Keywords: Vaginal lubricant
Lead sponsor: Reckitt Benckiser Healthcare (UK) Limited
Sponsor class: INDUSTRY
First posted: 2022-12-09
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Subject has provided written informed consent.
2. Subject is aged at least 18 years.
3. Subject in a mutually monogamous heterosexual relationship (≥3 months) who is sexually active, defined as having sexual intercourse at least once a week.
4. 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.
5. 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.
6. 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).
7. Pre-menopausal Inclusion Criteria: Female subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
8. Post-menopausal Inclusion Criteria: Female subject in post-menopausal phase defined as having amenorrhea (absence of menstruation) for at least 12 months.
9. 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:

1. 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.
2. Female subject with history of mucosal intolerance to warming agents.
3. Female subject with continuous or intermittent oral allergy syndrome or burning mouth syndrome of history of thereof.
4. Female subject with urinary, vaginal infection (fungal, bacterial) or sexually transmitted infection which may affect the study outcomes or the safety of the subject.
5. Female subject that has any condition of the oral cavity as determined by the investigator.
6. Male subject has broken skin or wounds in the intimate area.
7. Female subject with a history of skin disorder, which in the opinion of the investigation will affect study outcome.
8. Female subject with autoimmune conditions or any medical conditions which in the opinion of the investigator could compromise the immune function.
9. 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.
10. 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.
11. Female subject showing vaginal prolapse and/or other medical conditions that could interfere with the investigation conduct and participation.
12. 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.
13. Pre-menopausal Exclusion Criteria: Female subject who is pregnant (as confirmed by a positive pregnancy test), breast-feeding or trying to conceive.
14. Post-Menopausal Exclusion Criteria: Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months.

Primary outcomes:
measure: Female Sexual Function Index (FSFI) Score Compared to Baseline
timeFrame: 4 weeks after baseline
Secondary outcomes:
measure: Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores
timeFrame: 4 weeks after baseline
measure: Subject Perception of the Personal Lubricants Through Subject Perceived Questions
timeFrame: Initial application (within 24 hours of intercourse) and after 4 weeks
measure: The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion)
timeFrame: 4 weeks after baseline
measure: The Impression of Change in the Sexual Intimacy (Subjective Opinion)
timeFrame: 4 weeks after baseline
measure: The Assessment of the Vaginal Epithelial Tolerability (VET)
timeFrame: Baseline, 2 and 24 hours post single application
measure: Tolerability as Assessed by Subject Perceived Questions
timeFrame: 24 hours post single application
measure: The Assessment of Overall Tolerance for Each Participant
timeFrame: 24 hours post single application
measure: The Assessment of Oral Mucosal Tolerance
timeFrame: Baseline, 30 minutes, 2 hours and 24 hours post application
measure: Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs)
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: proDERM GmbH
Study officials:
affiliation: proDERM GmbH
name: Kirstin Deuble-Bente, Medical Doctor
role: PRINCIPAL_INVESTIGATOR
References: