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

NCT05644444 | Completed Results

• 1 other identifier: 5025003
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyspareunia; Vaginal Dryness

Keywords

Vaginal lubricant

Outcome Measures

Primary Outcomes (1)

• Female Sexual Function Index (FSFI) Score Compared to 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).

  4 weeks after baseline

Secondary Outcomes (9)

• Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores

  4 weeks after baseline

• Subject Perception of the Personal Lubricants Through Subject Perceived Questions

  Initial application (within 24 hours of intercourse) and after 4 weeks

• The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion)

  4 weeks after baseline

• The Impression of Change in the Sexual Intimacy (Subjective Opinion)

  4 weeks after baseline

• The Assessment of the Vaginal Epithelial Tolerability (VET)

  Baseline, 2 and 24 hours post single application

Study Arms (2)

Lubricant A and Comparator A

EXPERIMENTAL

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.

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

Lubricant B and Comparator B

EXPERIMENTAL

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.

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

Interventions

Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant) DEVICE

In the tolerance phase, a pea-sized lubricant will be considered a single application for oral assessment and approximately 3g of lubricant will be considered a single application for vaginal assessment. In the treatment phase, approximately 3g of lubricant will be considered a single application.

Lubricant A and Comparator A

Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant) DEVICE

In the tolerance phase, a pea-sized lubricant will be considered a single application for oral assessment and approximately 3g of lubricant will be considered a single application for vaginal assessment. In the treatment phase, approximately 3g of lubricant will be considered a single application.

Lubricant B and Comparator B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead

Study Sites (1)

proDERM GmbH

Hamburg, Germany

Location

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Results Point of Contact

• Title: Clinical Study Manager
• Organization: Reckitt Benckiser Health Limited

ClinicalRequests@reckitt.com

+44 (0)1482 326151

Study Officials

• Kirstin Deuble-Bente, Medical Doctor

  proDERM GmbH

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: December 9, 2022
• Study Start: February 20, 2023
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: February 11, 2025
• Results First Posted: February 11, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)