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

Primary Purpose

Dyspareunia, Vaginal Dryness

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)
Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)
Sponsored by
Reckitt Benckiser Healthcare (UK) Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyspareunia focused on measuring Vaginal lubricant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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). Pre-menopausal Inclusion Criteria: Female subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation. Post-menopausal Inclusion Criteria: Female subject in post-menopausal phase defined as having amenorrhea (absence of menstruation) for at least 12 months. 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: 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. Pre-menopausal Exclusion Criteria: Female subject who is pregnant (as confirmed by a positive pregnancy test), breast-feeding or trying to conceive. Post-Menopausal Exclusion Criteria: Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months.

Sites / Locations

  • proDERM GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Lubricant A and Comparator A

Lubricant B and Comparator B

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Female Sexual Function Index (FSFI) score compared to baseline
The change in FSFI from the baseline event and at 4-weeks post baseline

Secondary Outcome Measures

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
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
The evaluation of Product Effectiveness, Tolerability and Usability (subjective opinion)
Subjects will rate 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
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)
The assessment of the Vaginal Epithelial Tolerability (VET)
The gynaecolosit will make 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)
Tolerability as assessed by Subject Perceived Questions
Tolerability of the two personal lubricants will be determined through Subject Perceived Questions
The assessment of overall tolerance for each subject
The gynaecologist and dermatologist will make 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
Overall Tolerance Rating Statement for each lubricant by gynaecologist and by dermatologist
An overall summary statement of tolerance of each lubricant will be made by gynaecologist and by dermatologist, taking into consideration all tolerance assessments across all subjects
The assessment of oral mucosal tolerance
The dermatologist will make 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)
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per subject.

Full Information

First Posted
October 20, 2022
Last Updated
October 19, 2023
Sponsor
Reckitt Benckiser Healthcare (UK) Limited
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1. Study Identification

Unique Protocol Identification Number
NCT05644444
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
May 5, 2023 (Actual)
Study Completion Date
May 5, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reckitt Benckiser Healthcare (UK) Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyspareunia, Vaginal Dryness
Keywords
Vaginal lubricant

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lubricant A and Comparator A
Arm Type
Experimental
Arm Description
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.
Arm Title
Lubricant B and Comparator B
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)
Intervention Description
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
Intervention Name(s)
Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Female Sexual Function Index (FSFI) score compared to baseline
Description
The change in FSFI from the baseline event and at 4-weeks post baseline
Time Frame
4 weeks after baseline
Secondary Outcome Measure Information:
Title
Change from baseline in the Female Sexual Function Index (FSFI) individual domain scores
Description
Change from baseline in the FSFI individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain) at 4-weeks post baseline
Time Frame
4 weeks after baseline
Title
Subject perception of the personal lubricants through Subject Perceived Questions
Description
Subjects' perception of each of the two personal lubricants will be determined through Subject Perceived Questions
Time Frame
Initial application (within 24 hours of intercourse) and after 4 weeks
Title
The evaluation of Product Effectiveness, Tolerability and Usability (subjective opinion)
Description
Subjects will rate 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
Time Frame
4 weeks after baseline
Title
The impression of change in the sexual intimacy (subjective opinion)
Description
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)
Time Frame
4 weeks after baseline
Title
The assessment of the Vaginal Epithelial Tolerability (VET)
Description
The gynaecolosit will make 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)
Time Frame
Baseline, 2 and 24 hours post single application
Title
Tolerability as assessed by Subject Perceived Questions
Description
Tolerability of the two personal lubricants will be determined through Subject Perceived Questions
Time Frame
24 hours post single application
Title
The assessment of overall tolerance for each subject
Description
The gynaecologist and dermatologist will make 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
Time Frame
24 hours post single application
Title
Overall Tolerance Rating Statement for each lubricant by gynaecologist and by dermatologist
Description
An overall summary statement of tolerance of each lubricant will be made by gynaecologist and by dermatologist, taking into consideration all tolerance assessments across all subjects
Time Frame
24 hours post single application
Title
The assessment of oral mucosal tolerance
Description
The dermatologist will make 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)
Time Frame
Baseline, 30 minutes, 2 hours and 24 hours post single application
Title
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)
Description
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per subject.
Time Frame
10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Pre-menopausal Inclusion Criteria: Female subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation. Post-menopausal Inclusion Criteria: Female subject in post-menopausal phase defined as having amenorrhea (absence of menstruation) for at least 12 months. 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: 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. Pre-menopausal Exclusion Criteria: Female subject who is pregnant (as confirmed by a positive pregnancy test), breast-feeding or trying to conceive. Post-Menopausal Exclusion Criteria: Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirstin Deuble-Bente, Medical Doctor
Organizational Affiliation
proDERM GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
proDERM GmbH
City
Hamburg
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will be shared as per local regulations.

Learn more about this trial

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

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