DyspareuniaPhase 3NCT04908124
A Clinical Investigation Into the Effectiveness and Safety of Five Water Based Personal Lubricants.
A Phase 3 study testing Lubricant A, Lubricant B and Lubricant C in people with Dyspareunia and Vaginal Dryness, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Dyspareunia, Vaginal Dryness
- What is being tested?
- Lubricant A, Lubricant B and Lubricant C
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 183 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2021to 29 Jun 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
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- Post-menopausal Inclusion Criteria:
- 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.
Who cannot join
- 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.
Show all 24Show fewer
- 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.
- Female subject using vaginal douches and is unwilling to stop its use at least 2 weeks prior to screening and throughout the clinical investigation.
- Female subject has changed contraceptive medication within the past 3 months or intending to change contraceptive medications.
- Female subject has participated in another investigation within 3 months prior to screening.
- Subject who is an employee at the site or a partner or first-degree relative of the Investigator.
- Subject fails to satisfy the investigator of fitness to participate for any other reason.
- Post-Menopausal Exclusion Criteria:
- Female subject that has had previous episodes of vaginal bleeding of unknown origin within the last 6 months of the screening visit.
- Female subject showing vaginal prolapse and/or other medical conditions that could interfere with the study conduct and participation.
- Female subject that have used any kind of systemic and/or local hormonal products for the treatment of vaginal dryness or any other vaginal condition in the 3 months prior to screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Parallel-design, Clinical Investigation to Determine the Effectiveness and Safety of Five Water Based Personal Lubricants for the Relief of Intimate Discomfort Associated With Vaginal Dryness.
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.
Read the detailed description
This is an open label, five-arm, parallel-design clinical investigation determining the effectiveness and safety of five personal lubricants. This clinical investigation consists of two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter both the Tolerance Phase followed by the Treatment Phase. The remaining subjects will enter the Treatment Phase only.
- Conditions
- Dyspareunia, Vaginal Dryness
- Being tested
- Lubricant A, Lubricant B, Lubricant C, Lubricant D, Lubricant E
- Medical subject headings
- Dyspareunia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lubricant ADevice
Also called Durex Play Feel
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Lubricant BDevice
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Lubricant CDevice
Also called Durex Naturals Moisture
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Lubricant DDevice
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
Lubricant EDevice
Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Device: Lubricant E |
What is being measured
The primary outcome is the main question the study is designed to answer.
Female Sexual Function Index (FSFI) score compared to baseline
The Change in FSFI from the baseline event and at 4-weeks post baseline
Measured: 4 weeks after baseline
Secondary outcomes (8)
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
Measured: 4 weeks after baseline
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.
Measured: 4 weeks
Subject perception of the personal lubricants through Subject Percieved Questions
Subjects' perception of each of the five personal lubricants will be determined through Subject Perceived Questions
Measured: Initial application (within 24 hours of intercourse) and after 4 weeks
Global evaluation of the personal lubricants (subjective opinion)
- Subjects global evaluation of the five personal lubricants will be determined through global evaluation of effectiveness, tolerability and usability
Measured: 4 weeks after baseline
Vaginal Epithelial Tolerability (VET)
An assessment of the Vaginal Epithelial Tolerability (VET) of the five personal lubricants as assessed by gynaecologist examination.
Measured: Baseline, 2 and 24 hours post single application
Tolerability as assessed by Subject Perceived Questions
Tolerability of the five personal lubricants will be determined through Subject Perceived Questions
Measured: 24 hours post single application.
Global Assessment of Tolerance for each subject by a Gynaecologist
Determined by professional assessment of each individual.
Measured: 24 hours post single application
Overall Tolerance Rating Statement for each lubricant by a Gynaecologist
An overall summary statement of tolerance of each lubricant will be made by the Gynaecologist, taking into consideration all tolerance assessments across all subjects and the nature of the IP in its intended use
Measured: 24 hours post single application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2021
- Study start1 Mar 2021
- Primary completion29 Jun 2021
- Study completion29 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspareuniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Responsible party
- Sponsor
- Investigators
- Kirstin Deuble-Bente, Dr., Principal investigator, proDERM GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04908124
- Sponsor's protocol ID
- 5025002
- Status last verified
- Feb 2021
- First submitted
- 30 Mar 2021
- Last updated
- 2 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Parallel-design, Clinical Investigation to Determine the Effectiveness and Safety of Five Water Based Personal Lubricants for the Relief of Intimate Discomfort Associated With Vaginal Dryness.
- ClinicalTrials.gov ID
- NCT04908124
- Acronym / sponsor ID
- 5025002
- Conditions
- Dyspareunia, Vaginal Dryness
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Reckitt Benckiser Healthcare (UK) LimitedIndustry (pharma, biotech, devices)
- Collaborators
- proDERM GmbH
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 29 Jun 2021 (actual)
- First posted
- 1 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an open label, five-arm, parallel-design clinical investigation determining the effectiveness and safety of five personal lubricants. This clinical investigation consists of two phases, a Tolerance Phase and a Treatment Phase, whereby a sub-set of subjects will enter both the Tolerance Phase followed by the Treatment Phase. The remaining subjects will enter the Treatment Phase only.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 10
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Lubricant A - Tolerance | Experimental | Device: Lubricant AA 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. |
| Lubricant B - Tolerance | Experimental | Device: Lubricant BA 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. |
| Lubricant C - Tolerance | Experimental | Device: Lubricant CA 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. |
| Lubricant D - Tolerance | Experimental | Device: Lubricant DA 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. |
| Lubricant E - Tolerance | Experimental | Device: Lubricant EA 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. |
| Lubricant A - Treatment | Experimental | Device: Lubricant AA 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. |
| Lubricant B - Treatment | Experimental | Device: Lubricant BA 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. |
| Lubricant C - Treatment | Experimental | Device: Lubricant CA 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. |
| Lubricant D - Treatment | Experimental | Device: Lubricant DA 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. |
| Lubricant E - Treatment | Experimental | Device: Lubricant EA 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lubricant AAlso: Durex Play FeelWater-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application. | Device | Lubricant A - Tolerance, Lubricant A - Treatment |
| Lubricant BWater-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application. | Device | Lubricant B - Tolerance, Lubricant B - Treatment |
| Lubricant CAlso: Durex Naturals MoistureWater-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application. | Device | Lubricant C - Tolerance, Lubricant C - Treatment |
| Lubricant DWater-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application. | Device | Lubricant D - Tolerance, Lubricant D - Treatment |
| Lubricant EWater-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application. | Device | Lubricant E - Tolerance, Lubricant E - Treatment |
Primary outcome
Female Sexual Function Index (FSFI) score compared to baseline
Time frame: 4 weeks after baseline
The Change in FSFI from the baseline event and at 4-weeks post baseline
8 secondary outcomes
Change from baseline in the Female Sexual Function Index (FSFI) individual domain scores
Time frame: 4 weeks after baseline
Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs)
Time frame: 4 weeks
Subject perception of the personal lubricants through Subject Percieved Questions
Time frame: Initial application (within 24 hours of intercourse) and after 4 weeks
Global evaluation of the personal lubricants (subjective opinion)
Time frame: 4 weeks after baseline
Vaginal Epithelial Tolerability (VET)
Time frame: Baseline, 2 and 24 hours post single application
Tolerability as assessed by Subject Perceived Questions
Time frame: 24 hours post single application.
Global Assessment of Tolerance for each subject by a Gynaecologist
Time frame: 24 hours post single application
Overall Tolerance Rating Statement for each lubricant by a Gynaecologist
Time frame: 24 hours post single application
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirstin Deuble-Bente, Dr. principal investigator
proDERM GmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lubricant A, Lubricant B and Lubricant C in people with Dyspareunia and Vaginal Dryness, run by Reckitt Benckiser Healthcare (UK) Limited at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Female Sexual Function Index (FSFI) score compared to baseline (time frame: 4 weeks after baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2021.