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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lubricant A and Comparator A | Experimental | 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 and Comparator B | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lubricant A (sensate water-based personal lubricant) and Comparator A (non-sensate water-based lubricant) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 4 weeks after baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente, Medical Doctor | proDERM GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proDERM GmbH | Hamburg | Germany |
IPD will be shared as per local regulations.
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Participants meeting inclusion/exclusion criteria were enrolled and either entered the Tolerance Phase or directly into the Treatment Phase.
A single site single country study where recruitment was conducted from February 2023 to March 2023 via advertising at the clinical site.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Tolerance Phase |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2022 |
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The personal lubricants will be tested in a 2-arm parallel-design, where subjects will be randomised to an arm/lubricant. Subjects participating in the both the tolerance and treatment phases will be enrolled into an arm for each which includes the same IP/lubricant throughout both phases.
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|
| Lubricant B (sensate silicone-based personal lubricant) and Comparator B (non-sensate silicone-based personal lubricant) | Device | 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. |
|
| 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'. | 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. | 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) | 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) | 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'. | 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. | 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). | 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. | 10 weeks |
| FG001 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment Phase |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Female participants who were randomized to enter the Treatment Phase of the investigation | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after baseline |
|
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| ||||||||||||||||||||||||||||
| 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 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). | Female participants who were randomized to enter the Treatment Phase of the investigation | Posted | Mean | Standard Deviation | score on a scale | 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. 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'. | Female participants who were randomized to enter the Treatment Phase of the investigation. | Posted | Count of Participants | Participants | Initial application (within 24 hours of intercourse) and after 4 weeks |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Female participants who were randomized to enter the Treatment Phase of the investigation. | Posted | Count of Participants | Participants | 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) | Female participants who were randomized to enter the Treatment Phase of the investigation. | Posted | Mean | Standard Deviation | score on a scale | 4 weeks after baseline |
|
| |||||||||||||||||||||||||||||
| Secondary | 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) | Female participants who were randomized to enter the Tolerance Phase of the investigation. | Posted | Count of Participants | Participants | Baseline, 2 and 24 hours post single application |
|
| ||||||||||||||||||||||||||||||
| Secondary | 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'. | Female participants who were randomized to enter the Tolerance Phase of the investigation. | Posted | Count of Participants | Participants | 24 hours post single application |
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| ||||||||||||||||||||||||||||||
| Secondary | 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. | Female participants who were randomized to enter the Tolerance Phase of the investigation. | Posted | Count of Participants | Participants | 24 hours post single application |
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| Secondary | 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). | Female participants who were randomized to enter the Tolerance Phase of the investigation. | Posted | Count of Participants | Participants | Baseline, 30 minutes, 2 hours and 24 hours post application |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | 10 weeks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Lubricant A | Sensate water-based personal lubricant | 0 | 66 | 0 | 66 | 10 | 66 |
| EG001 | Lubricant B | Sensate silicone-based personal lubricant | 0 | 66 | 1 | 66 | 13 | 66 |
| EG002 | Comparator A | non-sensate water-based lubricant | 0 | 24 | 0 | 24 | 0 | 24 |
| EG003 | Comparator B | non-sensate silicone-based lubricant | 0 | 20 | 0 | 20 | 0 | 20 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 25.1 | Systematic Assessment |
| |
| Shoulder fracture | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| - Oral discomfort | Gastrointestinal disorders | MedDRA 25.1 | Systematic Assessment |
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| Toothache | Gastrointestinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
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| Vulvovaginal burning sensation | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 26.0 | Systematic Assessment |
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| Seasonal allergy | Immune system disorders | MedDRA 26.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 26.0 | Systematic Assessment |
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| Intentional device misuse | Injury, poisoning and procedural complications | MedDRA 26.0 | Systematic Assessment |
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| Muscle spasticity | Nervous system disorders | MedDRA 26.0 | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
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| Vaginal discomfort | Reproductive system and breast disorders | MedDRA 26.0 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Study Manager | Reckitt Benckiser Health Limited | +44 (0)1482 326151 | ClinicalRequests@reckitt.com |
| Aug 26, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
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| Male |
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| Asian (Female) |
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| Black (Female) |
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| Units | Counts |
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| Participants |
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| Disagree |
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| Strongly disagree |
|
| Disagree |
|
| Strongly disagree |
|
| Disagree |
|
| Strongly disagree |
|
| Disagree |
|
| Strongly disagree |
|
| Disagree |
|
| Strongly disagree |
|
| Neither satisfied nor dissatisfied |
|
| Somewhat dissatisfied |
|
| Very dissatisfied |
|
| Neither satisfied nor dissatisfied |
|
| Somewhat dissatisfied |
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| Very dissatisfied |
|
| Vulvar membrane |
|
| Leucorrhoea |
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| No Sign |
|
| Vulvar membrane |
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| Leucorrhoea |
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| No Sign |
|
| Disagree |
|
| Strongly disagree |
|
| Acceptable |
|
| Poor |
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| Very Poor |
|