An interventional study of Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant) and Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant) in Dyspareunia and Vaginal Dryness, sponsored by Reckitt Benckiser Healthcare (UK) Limited. Completed at 1 site in Germany. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Reckitt Benckiser Healthcare (UK) Limited (part of Reckitt) · Not applicable, Interventional, and Treatment
This clinical investigation will look at the effectiveness and safety of two personal lubricants for the relief of intimate discomfort associated with vaginal dryness.
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.
158 studies on the registry are indexed under Dyspareunia; 40 are open to participants now.
This study's enrollment of 132 is above the median of 63 across 126 interventional studies indexed under Dyspareunia.
Browse Dyspareunia studies →Reckitt Benckiser Healthcare (UK) Limited is the lead sponsor of 35 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant)
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.
Device: 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.
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.
Female Sexual Function Index (FSFI) Score Compared to Baseline
The change in FSFI from the baseline event and at 4-weeks post baseline. The FSFI is a 19-item self-report questionnaire to measure sexual functioning in women. The questionnaire assesses six domains of sexual function (sexual desire, sexual arousal, lubrication, orgasm, satisfaction and pain) and provides a total score for sexual function. For individual domain scores, add the scores of the individual questions that comprise the domain and multiply the sum by the domain factor. Add the six domain scores to obtain the total FSFI score. The range of total score is 2.0-36.0. Higher value represents a higher level of sexual function. This measure is the change in total FSFI score between baseline and end of treatment phase (4 weeks).
Time frame: 4 weeks after baseline
Change From Baseline in the Female Sexual Function Index (FSFI) Individual Domain Scores
Change from baseline in the FSFI individual domain scores (desire, arousal, lubrication, orgasm, satisfaction and pain) at 4-weeks post baseline For individual FSFI domain scores, add the scores of the individual questions that comprise the domain and multiply the sum by the domain factor. The range of each score is: Desire 1.2-6.0, Arousal 0-6.0, Lubrication 0-6.0, Orgasm 0-6.0, Satisfaction 0.8-6.0 and Pain 0-6.0. Higher value represents a higher level of individual sexual function. This measure is the change in individual FSFI score between baseline and end of treatment phase (4 weeks).
Time frame: 4 weeks after baseline
Subject Perception of the Personal Lubricants Through Subject Perceived Questions
Subjects' perception of each of the two personal lubricants will be determined through Subject Perceived Questions. Participants ranked a statement (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree) that best described the experience. Answering options "agree/strongly agree" were combined to the category 'agreement'.
Time frame: Initial application (within 24 hours of intercourse) and after 4 weeks
The Evaluation of Product Effectiveness, Tolerability and Usability (Subjective Opinion)
Participants rated their evaluation of Product Effectiveness, Tolerability and Usability after IP use using the following scale: Very Satisfied, Somewhat Satisfied, Neither Satisfied nor Dissatisfied, Somewhat Dissatisfied, Very Dissatisfied.
Time frame: 4 weeks after baseline
The Impression of Change in the Sexual Intimacy (Subjective Opinion)
Subjects' evaluation of improvement in sexual intimacy will be determined through the Patient Global Impression of Change (PGIC) questionnaire which is presented in a form of the visual analogue scale: -3 (much worse), -2, -1, 0 (no change), 1, 2, 3 (much better)
Time frame: 4 weeks after baseline
The Assessment of the Vaginal Epithelial Tolerability (VET)
The gynaecologist made an assessment of the VET based on the vaginal dermal tissue for signs and symptoms of erythema, oedema, vulvar membrane dryness, leucorrhoea by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe)
Time frame: Baseline, 2 and 24 hours post single application
Tolerability as Assessed by Subject Perceived Questions
Tolerability of the two personal lubricants was determined through Subject Perceived Questions. Participants ranked a statement (strongly agree, agree, neither agree nor disagree, disagree, strongly disagree) that best described the experience. Answering options "agree/strongly agree" were combined to the category 'agreement'.
Time frame: 24 hours post single application
The Assessment of Overall Tolerance for Each Participant
The gynaecologist and dermatologist made an assessment of tolerance of each subject for each IP based on measured parameters, any clinical signs of irritancy observed and subject's perception of vulvovaginal and oral mucosal tolerance by using the 5-point scale: very good, good, acceptable, poor, very poor.
Time frame: 24 hours post single application
The Assessment of Oral Mucosal Tolerance
The dermatologist made an assessment of oral mucosal tolerance based on the signs and symptoms of erythema, erosions, oedema and any other signs of clinical irritancy by using the 5-point scale: 1 (none), 2 (slight), 3 (minimal), 4 (moderate), 5 (severe).
Time frame: Baseline, 30 minutes, 2 hours and 24 hours post application
Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs)
Overall proportion of participants with Adverse Events/Adverse Device Effects (AEs/ADEs) i.e. the occurrence of one of more AE/ADE per participant.
Time frame: 10 weeks
A single site single country study where recruitment was conducted from February 2023 to March 2023 via advertising at the clinical site.
| Milestone | Lubricant A | Lubricant B |
|---|---|---|
| Started | 24 | 20 |
| Completed | 24 | 18 |
| Not completed | 0 | 2 |
| Withdrew: Adverse event | 0 | 2 |
| Milestone | Lubricant A | Lubricant B |
|---|---|---|
| Started | 66 | 66 |
| Completed | 66 | 64 |
| Not completed | 0 | 2 |
| Withdrew: Adverse event | 0 | 2 |
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).
| score on a scale | Lubricant A | Lubricant B |
|---|---|---|
| Female Sexual Function Index (FSFI) Score Compared to Baseline | 4.14 ± 4.45 | 5.95 ± 4.07 |
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).
| score on a scale | Lubricant A | Lubricant B |
|---|---|---|
| Domain Desire | 0.27 ± 0.77 | 0.17 ± 0.72 |
| Domain Arousal | 0.25 ± 0.83 | 0.62 ± 0.95 |
| Domain Lubrication | 1.00 ± 1.04 | 1.39 ± 0.96 |
| Domain Orgasm | 0.81 ± 1.18 | 0.98 ± 1.21 |
| Domain Satisfaction | 0.44 ± 1.13 | 0.74 ± 1.46 |
| Domain Pain | 1.37 ± 1.20 | 1.95 ± 1.24 |
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'.
| Participants | Lubricant A | Lubricant B |
|---|---|---|
| First penetration - Feel smoother (24 hours) — Agreement | 32 | 30 |
| First penetration - Feel smoother (24 hours) — Neither agree nor disagree | 1 | 2 |
| First penetration - Feel smoother (24 hours) — Disagree | 0 | 0 |
| First penetration - Feel smoother (24 hours) — Strongly disagree | 0 | 0 |
| First penetration - Feel smoother (after 4 weeks) — Agreement | 31 | 31 |
| First penetration - Feel smoother (after 4 weeks) — Neither agree nor disagree | 2 | 1 |
| First penetration - Feel smoother (after 4 weeks) — Disagree | 0 | 0 |
| First penetration - Feel smoother (after 4 weeks) — Strongly disagree | 0 | 0 |
| Continuous penetration - feel smoother (24 hours) — Agreement | 27 | 31 |
| Continuous penetration - feel smoother (24 hours) — Neither agree nor disagree | 5 | 1 |
| Continuous penetration - feel smoother (24 hours) — Disagree | 1 | 0 |
| Continuous penetration - feel smoother (24 hours) — Strongly disagree | 0 | 0 |
| Continuous penetration - feel smoother (after 4 weeks) — Agreement | 30 | 31 |
| Continuous penetration - feel smoother (after 4 weeks) — Neither agree nor disagree | 1 | 1 |
| Continuous penetration - feel smoother (after 4 weeks) — Disagree | 2 | 0 |
| Continuous penetration - feel smoother (after 4 weeks) — Strongly disagree | 0 | 0 |
| The lubricant enhances sexual experience (24 hours) — Agreement | 16 | 20 |
| The lubricant enhances sexual experience (24 hours) — Neither agree nor disagree | 9 | 8 |
| The lubricant enhances sexual experience (24 hours) — Disagree | 8 | 4 |
| The lubricant enhances sexual experience (24 hours) — Strongly disagree | 0 | 0 |
| The lubricant enhances sexual experience (after 4 weeks) — Agreement | 19 | 20 |
| The lubricant enhances sexual experience (after 4 weeks) — Neither agree nor disagree | 6 | 6 |
| The lubricant enhances sexual experience (after 4 weeks) — Disagree | 6 | 3 |
| The lubricant enhances sexual experience (after 4 weeks) — Strongly disagree | 2 | 3 |
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.
| Participants | Lubricant A | Lubricant B |
|---|---|---|
| Effectiveness — Very satisfied | 12 | 17 |
| Effectiveness — Somewhat satisfied | 14 | 11 |
| Effectiveness — Neither satisfied nor dissatisfied | 5 | 1 |
| Effectiveness — Somewhat dissatisfied | 2 | 3 |
| Effectiveness — Very dissatisfied | 0 | 0 |
| Tolerability — Very satisfied | 14 | 17 |
| Tolerability — Somewhat satisfied | 13 | 8 |
| Tolerability — Neither satisfied nor dissatisfied | 2 | 4 |
| Tolerability — Somewhat dissatisfied | 3 | 1 |
| Tolerability — Very dissatisfied | 1 | 2 |
| Usability — Very satisfied | 18 | 14 |
| Usability — Somewhat satisfied | 10 | 11 |
| Usability — Neither satisfied nor dissatisfied | 3 | 5 |
| Usability — Somewhat dissatisfied | 2 | 2 |
| Usability — Very dissatisfied | 0 | 0 |
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)
| score on a scale | Lubricant A | Lubricant B |
|---|---|---|
| The Impression of Change in the Sexual Intimacy (Subjective Opinion) | 1.27 ± 1.04 | 1.34 ± 1.26 |
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)
| Participants | Lubricant A | Lubricant B |
|---|---|---|
| Baseline — Erythema | 0 | 3 |
| Baseline — Oedema | 0 | 1 |
| Baseline — Vulvar membrane | 1 | 1 |
| Baseline — Leucorrhoea | 0 | 1 |
| Baseline — No Sign | 11 | 3 |
| 2 hours post application — Erythema | 0 | 1 |
| 2 hours post application — Oedema | 0 | 1 |
| 2 hours post application — Vulvar membrane | 0 | 0 |
| 2 hours post application — Leucorrhoea | 0 | 0 |
| 2 hours post application — No Sign | 12 | 7 |
| 24 hours post application — Erythema | 1 | 0 |
| 24 hours post application — Oedema | 0 | 0 |
| 24 hours post application — Vulvar membrane | 0 | 0 |
| 24 hours post application — Leucorrhoea | 0 | 0 |
| 24 hours post application — No Sign | 11 | 9 |
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'.
| Participants | Lubricant A | Lubricant B |
|---|---|---|
| Felt gentle on the skin in the vagina — Agreement | 9 | 8 |
| Felt gentle on the skin in the vagina — Neither agree nor disagree | 1 | 1 |
| Felt gentle on the skin in the vagina — Disagree | 2 | 0 |
| Felt gentle on the skin in the vagina — Strongly disagree | 0 | 0 |
| Felt gentle on the skin of the vulva — Agreement | 9 | 9 |
| Felt gentle on the skin of the vulva — Neither agree nor disagree | 1 | 0 |
| Felt gentle on the skin of the vulva — Disagree | 2 | 0 |
| Felt gentle on the skin of the vulva — Strongly disagree | 0 | 0 |
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.
| Participants | Lubricant A | Lubricant B |
|---|---|---|
| Vulvovaginal tolerance — Very Good | 7 | 5 |
| Vulvovaginal tolerance — Good | 5 | 4 |
| Vulvovaginal tolerance — Acceptable | 0 | 0 |
| Vulvovaginal tolerance — Poor | 0 | 0 |
| Vulvovaginal tolerance — Very Poor | 0 | 0 |
| Oral mucosal tolerance — Very Good | 11 | 8 |
| Oral mucosal tolerance — Good | 0 | 0 |
| Oral mucosal tolerance — Acceptable | 1 | 1 |
| Oral mucosal tolerance — Poor | 0 | 0 |
| Oral mucosal tolerance — Very Poor | 0 | 0 |
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).
| Participants | Lubricant A | Lubricant B |
|---|---|---|
| Baseline (Erythema, Erosions, Oedema, Any other signs) | 0 | 0 |
| 30 minutes post application (Erythema, Erosions, Oedema, Any other signs) | 0 | 0 |
| 2 hours post application (Erythema, Erosions, Oedema, Any other signs) | 0 | 0 |
| 24 hours post application (Erythema, Erosions, Oedema, Any other signs) | 0 | 0 |
| No Sign | 12 | 9 |
Overall proportion of participants with Adverse Events/Adverse Device Effects (AEs/ADEs) i.e. the occurrence of one of more AE/ADE per participant.
| Participants | Lubricant A | Lubricant B | Comparator A | Comparator B |
|---|---|---|---|---|
| Overall Proportion of Participants With Adverse Events/Adverse Device Effects (AEs/ADEs) | 10 | 13 | 0 | 0 |
Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lubricant A | 0/66 (0%) | 0/66 (0%) | 10/66 (15.2%) |
| Lubricant B | 0/66 (0%) | 1/66 (1.5%) | 13/66 (19.7%) |
| Comparator A | 0/24 (0%) | 0/24 (0%) | 0/24 (0%) |
| Comparator B | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Event | Lubricant A | Lubricant B | Comparator A | Comparator B |
|---|---|---|---|---|
| Foot fractureInjury, poisoning and procedural complications | 0/66 | 1/66 | 0/24 | 0/20 |
| Shoulder fractureInjury, poisoning and procedural complications | 0/66 | 1/66 | 0/24 | 0/20 |
| Event | Lubricant A | Lubricant B | Comparator A | Comparator B |
|---|---|---|---|---|
| Vulvovaginal burning sensationReproductive system and breast disorders | 4/66 | 2/66 | 0/24 | 0/20 |
| Intentional device misuseInjury, poisoning and procedural complications | 0/66 | 4/66 | 0/24 | 0/20 |
| HeadacheNervous system disorders | 3/66 | 1/66 | 0/24 | 0/20 |
| NasopharyngitisInfections and infestations | 2/66 | 0/66 | 0/24 | 0/20 |
| - Oral discomfortGastrointestinal disorders | 1/66 | 1/66 | 0/24 | 0/20 |
| ToothacheGastrointestinal disorders | 1/66 | 0/66 | 0/24 | 0/20 |
| DysmenorrhoeaReproductive system and breast disorders | 1/66 | 0/66 | 0/24 | 0/20 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/66 | 0/66 | 0/24 | 0/20 |
| Seasonal allergyImmune system disorders | 0/66 | 1/66 | 0/24 | 0/20 |
| COVID-19Infections and infestations | 0/66 | 1/66 | 0/24 | 0/20 |
| Age, Customized(Participants) | Lubricant A | Lubricant B | Total |
|---|---|---|---|
| Female 18-65 years | 33 | 33 | 66 |
| Male at least 18 years | 33 | 33 | 66 |
| Sex/Gender, Customized(Participants) | Lubricant A | Lubricant B | Total |
|---|---|---|---|
| Female | 33 | 33 | 66 |
| Male | 33 | 33 | 66 |
| Race/Ethnicity, Customized(Participants) | Lubricant A | Lubricant B | Total |
|---|---|---|---|
| Caucasian (Female) | 30 | 29 | 59 |
| Asian (Female) | 3 | 3 | 6 |
| Black (Female) | 0 | 1 | 1 |
| Region of Enrollment(Participants) | Lubricant A | Lubricant B | Total |
|---|---|---|---|
| Germany | 66 | 66 | 132 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — IPD will be shared as per local regulations.
Ran from Feb 2023 to primary completion in May 2023, 2 months.
Results were first posted in Feb 2025, 1 year 9 months after primary completion.
Of 59 interventional studies with no phase under Dyspareunia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 38. This study's 2 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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