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

Dyspareunia Clinical Trial

Official title:

A Two-arm, Parallel-design, Clinical Investigation to Determine the Effectiveness and Safety of a Water-based Personal Lubricant With a Sensory Action and Silicone-based Personal Lubricant With a Sensory Action for the Relief of Intimate Discomfort Associated With Vaginal Dryness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05644444
• Other study ID #: 5025003
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: May 5, 2023

Study information

• Verified date: October 2023
• Source: Reckitt Benckiser Healthcare (UK) Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 Exclusion Criteria: Female subject who is pregnant (as confirmed by a positive pregnancy test), breast-feeding or trying to conceive.

14. Post-Menopausal Exclusion Criteria: Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months.

Related Conditions & MeSH terms

• Dyspareunia
• Vaginal Dryness

Intervention

Device:
• 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 (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.

Locations

Country	Name	City	State
Germany	proDERM GmbH	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Reckitt Benckiser Healthcare (UK) Limited

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Female Sexual Function Index (FSFI) score compared to baseline	The change in FSFI from the baseline event and at 4-weeks post baseline	4 weeks after baseline
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	4 weeks after baseline
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	Initial application (within 24 hours of intercourse) and after 4 weeks
Secondary	The evaluation of Product Effectiveness, Tolerability and Usability (subjective opinion)	Subjects will rate their evaluation of Product Effectiveness, Tolerability and Usability after IP use using the following scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Very Dissatisfied	4 weeks after baseline
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)	4 weeks after baseline
Secondary	The assessment of the Vaginal Epithelial Tolerability (VET)	The gynaecolosit will make an assessment of the VET based on the vaginal dermal tissue for signs and symptoms of erythema, oedema, vulvar membrane dryness, leucorrhoea by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe)	Baseline, 2 and 24 hours post single application
Secondary	Tolerability as assessed by Subject Perceived Questions	Tolerability of the two personal lubricants will be determined through Subject Perceived Questions	24 hours post single application
Secondary	The assessment of overall tolerance for each subject	The gynaecologist and dermatologist will make an assessment of tolerance of each subject for each IP based on measured parameters, any clinical signs of irritancy observed and subject's perception of vulvovaginal and oral mucosal tolerance by using the 5-point scale: very good, good, acceptable, poor, very poor	24 hours post single application
Secondary	Overall Tolerance Rating Statement for each lubricant by gynaecologist and by dermatologist	An overall summary statement of tolerance of each lubricant will be made by gynaecologist and by dermatologist, taking into consideration all tolerance assessments across all subjects	24 hours post single application
Secondary	The assessment of oral mucosal tolerance	The dermatologist will make an assessment of oral mucosal tolerance based on the signs and symptoms of erythema, erosions, oedema and any other signs of clinical irritancy by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe)	Baseline, 30 minutes, 2 hours and 24 hours post single application
Secondary	Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)	Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per subject.	10 weeks