Trial Outcomes & Findings for Effectiveness and Safety of a Water-based and a Silicone-based Personal Lubricants With Sensory Action (NCT NCT05644444)

Last Updated: 2025-02-11

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

132 participants

Primary outcome timeframe

4 weeks after baseline

Results posted on

2025-02-11

Participant Flow

A single site single country study where recruitment was conducted from February 2023 to March 2023 via advertising at the clinical site.

Participants meeting inclusion/exclusion criteria were enrolled and either entered the Tolerance Phase or directly into the Treatment Phase.

Participant milestones

Participant milestones
Measure	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.	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.
Tolerance Phase STARTED	24	20
Tolerance Phase COMPLETED	24	18
Tolerance Phase NOT COMPLETED	0	2
Treatment Phase STARTED	66	66
Treatment Phase COMPLETED	66	64
Treatment Phase NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Tolerance Phase Adverse Event	0	2
Treatment Phase Adverse Event	0	2

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lubricant A n=66 Participants 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.	Lubricant B n=66 Participants 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.	Total n=132 Participants Total of all reporting groups
Age, Customized Female 18-65 years	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Age, Customized Male at least 18 years	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Sex/Gender, Customized Female	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Sex/Gender, Customized Male	33 Participants n=5 Participants	33 Participants n=7 Participants	66 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian (Female)	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Race/Ethnicity, Customized Asian (Female)	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Black (Female)	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment Germany	66 Participants n=5 Participants	66 Participants n=7 Participants	132 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks after baseline

Population: Female participants who were randomized to enter the Treatment Phase of the investigation

Outcome measures

Outcome measures
Measure	Lubricant A n=33 Participants Sensate water-based personal lubricant	Lubricant B n=32 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
Female Sexual Function Index (FSFI) Score Compared to Baseline	4.14 score on a scale Standard Deviation 4.45	5.95 score on a scale Standard Deviation 4.07	—	—

SECONDARY outcome

Timeframe: 4 weeks after baseline

Population: Female participants who were randomized to enter the Treatment Phase of the investigation

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).

Outcome measures

Outcome measures
Measure	Lubricant A n=33 Participants Sensate water-based personal lubricant	Lubricant B n=32 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
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	0.17 score on a scale Standard Deviation 0.72	—	—
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	0.62 score on a scale Standard Deviation 0.95	—	—
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	1.39 score on a scale Standard Deviation 0.96	—	—
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	0.98 score on a scale Standard Deviation 1.21	—	—
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	0.74 score on a scale Standard Deviation 1.46	—	—
Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores Domain Pain	1.37 score on a scale Standard Deviation 1.20	1.95 score on a scale Standard Deviation 1.24	—	—

SECONDARY outcome

Timeframe: 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.

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'.

Outcome measures

Outcome measures
Measure	Lubricant A n=33 Participants Sensate water-based personal lubricant	Lubricant B n=32 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (24 hours) · Agreement	32 Participants	30 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (24 hours) · Neither agree nor disagree	1 Participants	2 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (24 hours) · Disagree	0 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (24 hours) · Strongly disagree	0 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (after 4 weeks) · Agreement	31 Participants	31 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (after 4 weeks) · Neither agree nor disagree	2 Participants	1 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (after 4 weeks) · Disagree	0 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions First penetration - Feel smoother (after 4 weeks) · Strongly disagree	0 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (24 hours) · Agreement	27 Participants	31 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (24 hours) · Neither agree nor disagree	5 Participants	1 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (24 hours) · Disagree	1 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (24 hours) · Strongly disagree	0 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (after 4 weeks) · Agreement	30 Participants	31 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (after 4 weeks) · Neither agree nor disagree	1 Participants	1 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (after 4 weeks) · Disagree	2 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions Continuous penetration - feel smoother (after 4 weeks) · Strongly disagree	0 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (24 hours) · Agreement	16 Participants	20 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (24 hours) · Neither agree nor disagree	9 Participants	8 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (24 hours) · Disagree	8 Participants	4 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (24 hours) · Strongly disagree	0 Participants	0 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (after 4 weeks) · Agreement	19 Participants	20 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (after 4 weeks) · Neither agree nor disagree	6 Participants	6 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (after 4 weeks) · Disagree	6 Participants	3 Participants	—	—
Subject Perception of the Personal Lubricants Through Subject Perceived Questions The lubricant enhances sexual experience (after 4 weeks) · Strongly disagree	2 Participants	3 Participants	—	—

SECONDARY outcome

Timeframe: 4 weeks after baseline

Population: Female participants who were randomized to enter the Treatment Phase of the investigation.

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.

Outcome measures

Outcome measures
Measure	Lubricant A n=33 Participants Sensate water-based personal lubricant	Lubricant B n=32 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Tolerability · Very dissatisfied	1 Participants	2 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Effectiveness · Very satisfied	12 Participants	17 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Effectiveness · Somewhat satisfied	14 Participants	11 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Effectiveness · Neither satisfied nor dissatisfied	5 Participants	1 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Effectiveness · Somewhat dissatisfied	2 Participants	3 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Effectiveness · Very dissatisfied	0 Participants	0 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Tolerability · Very satisfied	14 Participants	17 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Tolerability · Somewhat satisfied	13 Participants	8 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Tolerability · Neither satisfied nor dissatisfied	2 Participants	4 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Tolerability · Somewhat dissatisfied	3 Participants	1 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Usability · Very satisfied	18 Participants	14 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Usability · Somewhat satisfied	10 Participants	11 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Usability · Neither satisfied nor dissatisfied	3 Participants	5 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Usability · Somewhat dissatisfied	2 Participants	2 Participants	—	—
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion) Usability · Very dissatisfied	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 4 weeks after baseline

Population: Female participants who were randomized to enter the Treatment Phase of the investigation.

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)

Outcome measures

Outcome measures
Measure	Lubricant A n=33 Participants Sensate water-based personal lubricant	Lubricant B n=32 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
The Impression of Change in the Sexual Intimacy (Subjective Opinion)	1.27 score on a scale Standard Deviation 1.04	1.34 score on a scale Standard Deviation 1.26	—	—

SECONDARY outcome

Timeframe: Baseline, 2 and 24 hours post single application

Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.

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)

Outcome measures

Outcome measures
Measure	Lubricant A n=12 Participants Sensate water-based personal lubricant	Lubricant B n=9 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
The Assessment of the Vaginal Epithelial Tolerability (VET) Baseline · Leucorrhoea	0 Participants	1 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) Baseline · Erythema	0 Participants	3 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) Baseline · Oedema	0 Participants	1 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) Baseline · Vulvar membrane	1 Participants	1 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) Baseline · No Sign	11 Participants	3 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 2 hours post application · Erythema	0 Participants	1 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 2 hours post application · Oedema	0 Participants	1 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 2 hours post application · Vulvar membrane	0 Participants	0 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 2 hours post application · Leucorrhoea	0 Participants	0 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 2 hours post application · No Sign	12 Participants	7 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 24 hours post application · Erythema	1 Participants	0 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 24 hours post application · Oedema	0 Participants	0 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 24 hours post application · Vulvar membrane	0 Participants	0 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 24 hours post application · Leucorrhoea	0 Participants	0 Participants	—	—
The Assessment of the Vaginal Epithelial Tolerability (VET) 24 hours post application · No Sign	11 Participants	9 Participants	—	—

SECONDARY outcome

Timeframe: 24 hours post single application

Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.

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'.

Outcome measures

Outcome measures
Measure	Lubricant A n=12 Participants Sensate water-based personal lubricant	Lubricant B n=9 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin in the vagina · Agreement	9 Participants	8 Participants	—	—
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin in the vagina · Neither agree nor disagree	1 Participants	1 Participants	—	—
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin in the vagina · Disagree	2 Participants	0 Participants	—	—
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin in the vagina · Strongly disagree	0 Participants	0 Participants	—	—
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin of the vulva · Agreement	9 Participants	9 Participants	—	—
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin of the vulva · Neither agree nor disagree	1 Participants	0 Participants	—	—
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin of the vulva · Disagree	2 Participants	0 Participants	—	—
Tolerability as Assessed by Subject Perceived Questions Felt gentle on the skin of the vulva · Strongly disagree	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: 24 hours post single application

Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.

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.

Outcome measures

Outcome measures
Measure	Lubricant A n=12 Participants Sensate water-based personal lubricant	Lubricant B n=9 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
The Assessment of Overall Tolerance for Each Participant Vulvovaginal tolerance · Good	5 Participants	4 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Vulvovaginal tolerance · Very Good	7 Participants	5 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Vulvovaginal tolerance · Acceptable	0 Participants	0 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Vulvovaginal tolerance · Poor	0 Participants	0 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Vulvovaginal tolerance · Very Poor	0 Participants	0 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Oral mucosal tolerance · Very Good	11 Participants	8 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Oral mucosal tolerance · Good	0 Participants	0 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Oral mucosal tolerance · Acceptable	1 Participants	1 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Oral mucosal tolerance · Poor	0 Participants	0 Participants	—	—
The Assessment of Overall Tolerance for Each Participant Oral mucosal tolerance · Very Poor	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: Baseline, 30 minutes, 2 hours and 24 hours post application

Population: Female participants who were randomized to enter the Tolerance Phase of the investigation.

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).

Outcome measures

Outcome measures
Measure	Lubricant A n=12 Participants Sensate water-based personal lubricant	Lubricant B n=9 Participants Sensate silicone-based personal lubricant	Comparator A non-sensate water-based lubricant	Comparator B non-sensate silicone-based lubricant
The Assessment of Oral Mucosal Tolerance Baseline (Erythema, Erosions, Oedema, Any other signs)	0 Participants	0 Participants	—	—
The Assessment of Oral Mucosal Tolerance 30 minutes post application (Erythema, Erosions, Oedema, Any other signs)	0 Participants	0 Participants	—	—
The Assessment of Oral Mucosal Tolerance 2 hours post application (Erythema, Erosions, Oedema, Any other signs)	0 Participants	0 Participants	—	—
The Assessment of Oral Mucosal Tolerance 24 hours post application (Erythema, Erosions, Oedema, Any other signs)	0 Participants	0 Participants	—	—
The Assessment of Oral Mucosal Tolerance No Sign	12 Participants	9 Participants	—	—

SECONDARY outcome

Timeframe: 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.

Overall proportion of participants with Adverse Events/Adverse Device Effects (AEs/ADEs) i.e. the occurrence of one of more AE/ADE per participant.

Outcome measures

Outcome measures
Measure	Lubricant A n=66 Participants Sensate water-based personal lubricant	Lubricant B n=66 Participants Sensate silicone-based personal lubricant	Comparator A n=24 Participants non-sensate water-based lubricant	Comparator B n=20 Participants non-sensate silicone-based lubricant
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs)	10 Participants	13 Participants	0 Participants	0 Participants

Adverse Events

Lubricant A

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Lubricant B

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Comparator A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Comparator B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Lubricant A n=66 participants at risk Sensate water-based personal lubricant	Lubricant B n=66 participants at risk Sensate silicone-based personal lubricant	Comparator A n=24 participants at risk non-sensate water-based lubricant	Comparator B n=20 participants at risk non-sensate silicone-based lubricant
Injury, poisoning and procedural complications Foot fracture	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Injury, poisoning and procedural complications Shoulder fracture	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.

Other adverse events

Other adverse events
Measure	Lubricant A n=66 participants at risk Sensate water-based personal lubricant	Lubricant B n=66 participants at risk Sensate silicone-based personal lubricant	Comparator A n=24 participants at risk non-sensate water-based lubricant	Comparator B n=20 participants at risk non-sensate silicone-based lubricant
Gastrointestinal disorders - Oral discomfort	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Gastrointestinal disorders Toothache	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Infections and infestations Nasopharyngitis	3.0% 2/66 • Number of events 2 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Nervous system disorders Headache	4.5% 3/66 • Number of events 8 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Reproductive system and breast disorders Dysmenorrhoea	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Reproductive system and breast disorders Vulvovaginal burning sensation	6.1% 4/66 • Number of events 11 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	3.0% 2/66 • Number of events 2 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Respiratory, thoracic and mediastinal disorders Cough	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Immune system disorders Seasonal allergy	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Infections and infestations COVID-19	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Injury, poisoning and procedural complications Intentional device misuse	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	6.1% 4/66 • Number of events 13 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Nervous system disorders Muscle spasticity	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
Reproductive system and breast disorders Vaginal discomfort	0.00% 0/66 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	1.5% 1/66 • Number of events 1 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/24 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.	0.00% 0/20 • 10 weeks An AE is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs (including an abnormal laboratory finding) in participants, in the context of an investigation, whether or not related to the investigational product. This includes events that are anticipated as well as unanticipated events. This includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.

Additional Information

Clinical Study Manager

Reckitt Benckiser Health Limited

Phone: +44 (0)1482 326151

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Publication of the results of the Study, whether in whole or in part, shall be within the sole and absolute discretion of Reckitt, and PI shall not be entitled to publish any of the data or information arising during the Study without the prior written consent of Reckitt.
Publication restrictions are in place

Restriction type: OTHER