A Clinical Investigation Into the Effectiveness and Safety of Five Water Based Personal Lubricants.

NCT04908124 | Completed Phase 3

• 1 other identifier: 5025002
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical investigation will look at the safety of five water based personal lubricants, and teir effectiveness the relief of intimate discomfort associated with vaginal dryness.

Conditions

Dyspareunia; Vaginal Dryness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Change from baseline in the Female Sexual Function Index (FSFI) individual domain scores

  4 weeks after baseline

• Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)

  4 weeks

• Subject perception of the personal lubricants through Subject Percieved Questions

  Initial application (within 24 hours of intercourse) and after 4 weeks

• Global evaluation of the personal lubricants (subjective opinion)

  4 weeks after baseline

• Vaginal Epithelial Tolerability (VET)

  Baseline, 2 and 24 hours post single application

Study Arms (10)

Lubricant A - Tolerance

EXPERIMENTAL

A 3-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.

Device: Lubricant A

Lubricant B - Tolerance

EXPERIMENTAL

A 3-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.

Device: Lubricant B

Lubricant C - Tolerance

EXPERIMENTAL

A 3-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.

Device: Lubricant C

Lubricant D - Tolerance

EXPERIMENTAL

A 3-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.

Device: Lubricant D

Lubricant E - Tolerance

EXPERIMENTAL

A 3-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.

Device: Lubricant E

Lubricant A - Treatment

EXPERIMENTAL

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. This includes a sub-set population who were also enrolled into the arm using the same IP for the tolerability phase.

Device: Lubricant A

Lubricant B - Treatment

EXPERIMENTAL

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. This includes a sub-set population who were also enrolled into the arm using the same IP for the tolerability phase.

Device: Lubricant B

Lubricant C - Treatment

EXPERIMENTAL

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. This includes a sub-set population who were also enrolled into the arm using the same IP for the tolerability phase.

Device: Lubricant C

Lubricant D - Treatment

EXPERIMENTAL

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. This includes a sub-set population who were also enrolled into the arm using the same IP for the tolerability phase.

Device: Lubricant D

Lubricant E - Treatment

EXPERIMENTAL

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. This includes a sub-set population who were also enrolled into the arm using the same IP for the tolerability phase.

Device: Lubricant E

Interventions

Lubricant A DEVICE

Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.

Also known as: Durex Play Feel

Lubricant A - Tolerance; Lubricant A - Treatment

Lubricant B DEVICE

Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.

Lubricant B - Tolerance; Lubricant B - Treatment

Lubricant C DEVICE

Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.

Also known as: Durex Naturals Moisture

Lubricant C - Tolerance; Lubricant C - Treatment

Lubricant D DEVICE

Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.

Lubricant D - Tolerance; Lubricant D - Treatment

Lubricant E DEVICE

Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.

Lubricant E - Tolerance; Lubricant E - Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has provided written informed consent.
• Subject is female and aged: 18 years to 65 years.
• Female subject in a mutually monogamous heterosexual relationship (≥ 3 months) who is sexually active, defined as having sexual intercourse at least once a week.
• Female subject of childbearing potential who is willing to use a highly effective method of contraception throughout the clinical investigation.
• 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.
• 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).
• Female subject in post-menopausal phase defined as having amenorrhea (absence of menstruation) for at least 12 months.
• Female subject with premature menopause - surgical menopause or physiological menopause within the last 12 months or after having received chemotherapy.

You may not qualify if:

• Female subject who is pregnant, breast-feeding or trying to conceive.
• Female subject who has previously experienced an irritant or allergic reaction to any personal lubricant, vaginal moisturiser or female hygiene product or known to suffer from any contact allergen and/or are allergic to the investigational product ingredients.
• Female subject has urinary, vaginal infection (fungal, bacterial) or sexually transmitted infection as diagnosed by the investigator.
• Female subject presenting signs of internal irritation, active psoriasis, eczema or other active skin disorder or with a history of skin disorder
• Female subject presenting clinically abnormal findings other than irritation during the physical examination that will affect study outcome.
• Female subject who has started, stopped or changed hormonal treatments (including contraceptives) during the previous 3 months prior to screening.
• Female subject who has used any kind of topical histamine and/or topical hormonal based product for local treatment of vaginal dryness in the past 3 months.
• Female subject with any medical conditions which in the opinion of the investigator could compromise the immune function.
• Female subject taking steroid preparations, immune-suppressive drugs or any other medication which in the opinion of the investigator may affect the test results.
• Female subject who has had any change to medication or treatment regimen for the treatment of diabetes mellitus during the previous 3 months prior to screening.
• Female subject that will be unable to comply fully with the study requirements or unable to tolerate the procedures.
• Female subject that have had a suspicion of malignancy or history of malignancy within the past 2 years.
• Female subject who has had surgical cervical excision or vaginal and/or vulvar procedures in the previous year.
• Female subject that has had a positive cervical screening examination for Human Papillomavirus (HPV) within the 3 years of the screening visit.
• Female subject currently being treated with systemic medications or medicines that act locally in the vaginal area.

Sponsors & Collaborators

• Reckitt Benckiser Healthcare (UK) Limited: lead
• proDERM GmbH: collaborator

Study Sites (1)

proDERM GmbH

Hamburg, Pinneberg, 22869, Germany

Location

MeSH Terms

Conditions

Dyspareunia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Kirstin Deuble-Bente, Dr.

  proDERM GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The personal lubricants will be tested in a 5-arm parallel-design, where subjects will be randomised to an arm/lubricant. This follows an initial tolerance phase conducted in a sub-set of the population which will be tested in a 5-arm parrallel design,where subjects will be randomised to an arm/lubricant. Note: subjects participating in the both the tolerability and treatment phases will be enrolled into an arm for each which includes the same IP/lubricant throughout both phases.

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: June 1, 2021
• Study Start: March 1, 2021
• Primary Completion: June 29, 2021
• Study Completion: June 29, 2021
• Last Updated: July 2, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)