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

NCT ID: NCT05644444

Last Updated: 2025-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-20
• Study Completion Date: 2023-05-05

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.

Conditions

Dyspareunia; Vaginal Dryness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Reckitt Benckiser Healthcare (UK) Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kirstin Deuble-Bente, Medical Doctor

Role: PRINCIPAL_INVESTIGATOR

proDERM GmbH

Locations

proDERM GmbH

Hamburg, , Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5025003

Identifier Type: -

Identifier Source: org_study_id