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

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

This clinical investigation will look at the effectiveness and safety of two personal lubricants for the relief of intimate discomfort associated with vaginal dryness.

Study Overview

• Status: Completed
• Conditions: Vaginal Dryness; Dyspareunia
• Intervention / Treatment: Device: Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant); Device: Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)

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.

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany
    • proDERM GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lubricant A and Comparator A; 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); 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.
Experimental: Lubricant B and Comparator B; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores	Change from baseline in the FSFI individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain) at 4-weeks post baseline For individual FSFI domain scores, add the scores of the individual questions that comprise the domain and multiply the sum by the domain factor. The range of each score is: Desire 1.2-6.0, Arousal 0-6.0, Lubrication 0-6.0, Orgasm 0-6.0, Satisfaction 0.8-6.0 and Pain 0-6.0. Higher value represents a higher level of individual sexual function. This measure is the change in individual FSFI score between baseline and end of treatment phase (4 weeks).	4 weeks after baseline
Subject Perception of the Personal Lubricants Through Subject Perceived Questions	Subjects' perception of each of the two personal lubricants will be determined through Subject Perceived Questions. Participants ranked a statement (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree) that best described the experience. Answering options "agree/strongly agree" were combined to the category 'agreement'.	Initial application (within 24 hours of intercourse) and after 4 weeks
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion)	Participants rated their evaluation of Product Effectiveness, Tolerability and Usability after IP use using the following scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Very Dissatisfied.	4 weeks after baseline
The Impression of Change in the Sexual Intimacy (Subjective Opinion)	Subjects' evaluation of improvement in sexual intimacy will be determined through the Patient Global Impression of Change (PGIC) questionnaire which is presented in a form of the visual analogue scale: -3 (much worse), -2, -1, 0 (no change), 1, 2, 3 (much better)	4 weeks after baseline
The Assessment of the Vaginal Epithelial Tolerability (VET)	The gynaecologist made an assessment of the VET based on the vaginal dermal tissue for signs and symptoms of erythema, oedema, vulvar membrane dryness, leucorrhoea by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe)	Baseline, 2 and 24 hours post single application
Tolerability as Assessed by Subject Perceived Questions	Tolerability of the two personal lubricants was determined through Subject Perceived Questions. Participants ranked a statement (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree) that best described the experience. Answering options "agree/strongly agree" were combined to the category 'agreement'.	24 hours post single application
The Assessment of Overall Tolerance for Each Participant	The gynaecologist and dermatologist made an assessment of tolerance of each subject for each IP based on measured parameters, any clinical signs of irritancy observed and subject's perception of vulvovaginal and oral mucosal tolerance by using the 5-point scale: very good, good, acceptable, poor, very poor.	24 hours post single application
The Assessment of Oral Mucosal Tolerance	The dermatologist made an assessment of oral mucosal tolerance based on the signs and symptoms of erythema, erosions, oedema and any other signs of clinical irritancy by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe).	Baseline, 30 minutes, 2 hours and 24 hours post application
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs)	Overall proportion of participants with Adverse Events/Adverse Device Effects (AEs/ADEs) i.e. the occurrence of one of more AE/ADE per participant.	10 weeks

Collaborators and Investigators

• Sponsor: Reckitt Benckiser Healthcare (UK) Limited
• Investigators: Principal Investigator: Kirstin Deuble-Bente, Medical Doctor, proDERM GmbH

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): May 5, 2023
• Study Completion (Actual): May 5, 2023

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: December 6, 2022
• First Posted (Actual): December 9, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Vaginal lubricant
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Dyspareunia
• Other Study ID Numbers: 5025003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will be shared as per local regulations.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No