Dyspareunia, Vaginal Dryness
Conditions
Keywords
Vaginal lubricant
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.
Interventions
DEVICELubricant 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.
DEVICELubricant 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.
Sponsors
Reckitt Benckiser Healthcare (UK) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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). 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Female Sexual Function Index (FSFI) Score Compared to Baseline | 4 weeks after 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Initial application (within 24 hours of intercourse) and after 4 weeks | 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'. |
| The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | 4 weeks after baseline | 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. |
| The Impression of Change in the Sexual Intimacy (Subjective Opinion) | 4 weeks after baseline | 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) | Baseline, 2 and 24 hours post single application | 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) |
| Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | 4 weeks after baseline | 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). |
| The Assessment of Overall Tolerance for Each Participant | 24 hours post single application | 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. |
| The Assessment of Oral Mucosal Tolerance | Baseline, 30 minutes, 2 hours and 24 hours post application | 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). |
| Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs) | 10 weeks | Overall proportion of participants with Adverse Events/Adverse Device Effects (AEs/ADEs) i.e. the occurrence of one of more AE/ADE per participant. |
| Tolerability as Assessed by Subject Perceived Questions | 24 hours post single application | 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'. |
Countries
Germany
Participant flow
Recruitment details
A single site single country study where recruitment was conducted from February 2023 to March 2023 via advertising at the clinical site.
Pre-assignment details
Participants meeting inclusion/exclusion criteria were enrolled and either entered the Tolerance Phase or directly into the Treatment Phase.
Participants by arm
| Arm | Count |
|---|---|
| Lubricant 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.
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. | 66 |
| Lubricant 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.
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. | 66 |
| Total | 132 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Tolerance Phase | Adverse Event | 0 | 2 |
| Treatment Phase | Adverse Event | 0 | 2 |
Baseline characteristics
| Characteristic | Lubricant A | Lubricant B | Total |
|---|---|---|---|
| Age, Customized Female 18-65 years | 33 Participants | 33 Participants | 66 Participants |
| Age, Customized Male at least 18 years | 33 Participants | 33 Participants | 66 Participants |
| Race/Ethnicity, Customized Asian (Female) | 3 Participants | 3 Participants | 6 Participants |
| Race/Ethnicity, Customized Black (Female) | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian (Female) | 30 Participants | 29 Participants | 59 Participants |
| Region of Enrollment Germany | 66 Participants | 66 Participants | 132 Participants |
| Sex/Gender, Customized Female | 33 Participants | 33 Participants | 66 Participants |
| Sex/Gender, Customized Male | 33 Participants | 33 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 66 | 0 / 66 | 0 / 24 | 0 / 20 |
| other Total, other adverse events | 10 / 66 | 13 / 66 | 0 / 24 | 0 / 20 |
| serious Total, serious adverse events | 0 / 66 | 1 / 66 | 0 / 24 | 0 / 20 |
Outcome results
Primary
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).
Time frame: 4 weeks after baseline
Population: Female participants who were randomized to enter the Treatment Phase of the investigation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubricant A | Female Sexual Function Index (FSFI) Score Compared to Baseline | 4.14 score on a scale | Standard Deviation 4.45 |
| Lubricant B | Female Sexual Function Index (FSFI) Score Compared to Baseline | 5.95 score on a scale | Standard Deviation 4.07 |
Secondary
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).
Time frame: 4 weeks after baseline
Population: Female participants who were randomized to enter the Treatment Phase of the investigation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Lubricant A | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Arousal | 0.25 score on a scale | Standard Deviation 0.83 |
| Lubricant A | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Orgasm | 0.81 score on a scale | Standard Deviation 1.18 |
| Lubricant A | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Desire | 0.27 score on a scale | Standard Deviation 0.77 |
| Lubricant A | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Satisfaction | 0.44 score on a scale | Standard Deviation 1.13 |
| Lubricant A | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Lubrication | 1.00 score on a scale | Standard Deviation 1.04 |
| Lubricant A | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Pain | 1.37 score on a scale | Standard Deviation 1.2 |
| Lubricant B | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Pain | 1.95 score on a scale | Standard Deviation 1.24 |
| Lubricant B | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Desire | 0.17 score on a scale | Standard Deviation 0.72 |
| Lubricant B | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Arousal | 0.62 score on a scale | Standard Deviation 0.95 |
| Lubricant B | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Lubrication | 1.39 score on a scale | Standard Deviation 0.96 |
| Lubricant B | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Orgasm | 0.98 score on a scale | Standard Deviation 1.21 |
| Lubricant B | Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores | Domain Satisfaction | 0.74 score on a scale | Standard Deviation 1.46 |
Secondary
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.
Time frame: 10 weeks
Population: Female and male participants who were enrolled to the investigation. For comparators: Female and male participants who were randomized to enter the Tolerance Phase of the investigation.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Lubricant A | Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs) | 10 Participants |
| Lubricant B | Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs) | 13 Participants |
| Comparator A | Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs) | 0 Participants |
| Comparator B | Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs) | 0 Participants |
Secondary
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'.
Time frame: Initial application (within 24 hours of intercourse) and after 4 weeks
Population: Female participants who were randomized to enter the Treatment Phase of the investigation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Disagree | 0 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Neither agree nor disagree | 1 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Disagree | 0 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Strongly disagree | 0 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Agreement | 31 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Neither agree nor disagree | 2 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Agreement | 32 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Strongly disagree | 0 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Agreement | 27 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Neither agree nor disagree | 5 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Disagree | 1 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Strongly disagree | 0 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Agreement | 30 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Neither agree nor disagree | 1 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Disagree | 2 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Strongly disagree | 0 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Agreement | 16 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Neither agree nor disagree | 9 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Disagree | 8 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Strongly disagree | 0 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Agreement | 19 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Neither agree nor disagree | 6 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Disagree | 6 Participants |
| Lubricant A | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Strongly disagree | 2 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Disagree | 3 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Agreement | 30 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Agreement | 31 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Neither agree nor disagree | 2 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Disagree | 4 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Neither agree nor disagree | 1 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (24 hours) | Strongly disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Neither agree nor disagree | 6 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Agreement | 31 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Neither agree nor disagree | 1 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Strongly disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (after 4 weeks) | Strongly disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | First penetration - Feel smoother (after 4 weeks) | Strongly disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Strongly disagree | 3 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Agreement | 31 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Agreement | 20 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Neither agree nor disagree | 1 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (after 4 weeks) | Agreement | 20 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Disagree | 0 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | The lubricant enhances sexual experience (24 hours) | Neither agree nor disagree | 8 Participants |
| Lubricant B | Subject Perception of the Personal Lubricants Through Subject Perceived Questions | Continuous penetration - feel smoother (24 hours) | Strongly disagree | 0 Participants |
Secondary
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).
Time frame: Baseline, 30 minutes, 2 hours and 24 hours post application
Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lubricant A | The Assessment of Oral Mucosal Tolerance | 30 minutes post application (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
| Lubricant A | The Assessment of Oral Mucosal Tolerance | 24 hours post application (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
| Lubricant A | The Assessment of Oral Mucosal Tolerance | 2 hours post application (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
| Lubricant A | The Assessment of Oral Mucosal Tolerance | No Sign | 12 Participants |
| Lubricant A | The Assessment of Oral Mucosal Tolerance | Baseline (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
| Lubricant B | The Assessment of Oral Mucosal Tolerance | No Sign | 9 Participants |
| Lubricant B | The Assessment of Oral Mucosal Tolerance | Baseline (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
| Lubricant B | The Assessment of Oral Mucosal Tolerance | 30 minutes post application (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
| Lubricant B | The Assessment of Oral Mucosal Tolerance | 2 hours post application (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
| Lubricant B | The Assessment of Oral Mucosal Tolerance | 24 hours post application (Erythema, Erosions, Oedema, Any other signs) | 0 Participants |
Secondary
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.
Time frame: 24 hours post single application
Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Very Good | 7 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Good | 5 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Acceptable | 0 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Poor | 0 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Very Poor | 0 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Very Good | 11 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Good | 0 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Acceptable | 1 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Poor | 0 Participants |
| Lubricant A | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Very Poor | 0 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Acceptable | 1 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Very Good | 5 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Very Good | 8 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Good | 4 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Very Poor | 0 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Acceptable | 0 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Good | 0 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Poor | 0 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Oral mucosal tolerance | Poor | 0 Participants |
| Lubricant B | The Assessment of Overall Tolerance for Each Participant | Vulvovaginal tolerance | Very Poor | 0 Participants |
Secondary
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)
Time frame: Baseline, 2 and 24 hours post single application
Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Vulvar membrane | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Erythema | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Leucorrhoea | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | No Sign | 12 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | No Sign | 11 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Erythema | 1 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Vulvar membrane | 1 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Oedema | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Erythema | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Vulvar membrane | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Oedema | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Leucorrhoea | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Oedema | 0 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | No Sign | 11 Participants |
| Lubricant A | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Leucorrhoea | 0 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | No Sign | 9 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Erythema | 3 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Oedema | 1 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Vulvar membrane | 1 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | Leucorrhoea | 1 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | Baseline | No Sign | 3 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Erythema | 1 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Oedema | 1 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Vulvar membrane | 0 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | No Sign | 7 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Erythema | 0 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Oedema | 0 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Vulvar membrane | 0 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 24 hours post application | Leucorrhoea | 0 Participants |
| Lubricant B | The Assessment of the Vaginal Epithelial Tolerability (VET) | 2 hours post application | Leucorrhoea | 0 Participants |
Secondary
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.
Time frame: 4 weeks after baseline
Population: Female participants who were randomized to enter the Treatment Phase of the investigation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Very dissatisfied | 0 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Somewhat dissatisfied | 3 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Somewhat satisfied | 14 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Very dissatisfied | 1 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Very satisfied | 14 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Very satisfied | 18 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Somewhat dissatisfied | 2 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Somewhat satisfied | 10 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Somewhat satisfied | 13 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Neither satisfied nor dissatisfied | 3 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Neither satisfied nor dissatisfied | 5 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Somewhat dissatisfied | 2 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Neither satisfied nor dissatisfied | 2 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Very dissatisfied | 0 Participants |
| Lubricant A | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Very satisfied | 12 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Very dissatisfied | 0 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Very satisfied | 17 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Somewhat satisfied | 11 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Neither satisfied nor dissatisfied | 1 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Somewhat dissatisfied | 3 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Effectiveness | Very dissatisfied | 0 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Very satisfied | 17 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Somewhat satisfied | 8 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Neither satisfied nor dissatisfied | 4 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Somewhat dissatisfied | 1 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Tolerability | Very dissatisfied | 2 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Very satisfied | 14 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Somewhat satisfied | 11 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Neither satisfied nor dissatisfied | 5 Participants |
| Lubricant B | The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) | Usability | Somewhat dissatisfied | 2 Participants |
Secondary
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)
Time frame: 4 weeks after baseline
Population: Female participants who were randomized to enter the Treatment Phase of the investigation.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lubricant A | The Impression of Change in the Sexual Intimacy (Subjective Opinion) | 1.27 score on a scale | Standard Deviation 1.04 |
| Lubricant B | The Impression of Change in the Sexual Intimacy (Subjective Opinion) | 1.34 score on a scale | Standard Deviation 1.26 |
Secondary
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'.
Time frame: 24 hours post single application
Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Agreement | 9 Participants |
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Neither agree nor disagree | 1 Participants |
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Disagree | 2 Participants |
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Strongly disagree | 0 Participants |
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Agreement | 9 Participants |
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Neither agree nor disagree | 1 Participants |
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Disagree | 2 Participants |
| Lubricant A | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Strongly disagree | 0 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Strongly disagree | 0 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Agreement | 8 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Agreement | 9 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Neither agree nor disagree | 1 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Disagree | 0 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Disagree | 0 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin of the vulva | Neither agree nor disagree | 0 Participants |
| Lubricant B | Tolerability as Assessed by Subject Perceived Questions | Felt gentle on the skin in the vagina | Strongly disagree | 0 Participants |