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Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT05644444•Reckitt Benckiser Healthcare (UK) Limited

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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).

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.
+2 more criteria

Locations (1)

proDERM GmbH

Hamburg, Germany

Key Dates

Start Date

February 20, 2023

Primary Completion Date

May 5, 2023

Completion Date

May 5, 2023

Last Updated

February 11, 2025

Enrollment

132

ACTUAL participants

Conditions

DyspareuniaVaginal Dryness

Interventions

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)

DEVICE

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

NCT06900374

Vaginal DrynessBreast Cancer+1 more

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RECRUITINGNA

Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum.

NCT05417334

Dyspareunia

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Vaginal Radiofrequency for Vulvovaginal Atrophy in Breast Cancer Patients

Effect of Radiofrequency in the Treatment of de Novo Dyspareunia at 4 to 16 Months Postpartum.

Effectiveness of a Telerehabilitation Program for Improving Sexual Function and Reducing Pain in Menopausal Women

Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach

Evaluation of the Efficacy and Safety of Mucogye® Gel as a Moisturizer

Nerve Fiber Density in DIE Nodules & Pelvic Pain