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| Name | Class |
|---|---|
| proDERM GmbH | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 | 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 | 4 weeks after baseline |
| Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) |
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Inclusion Criteria:
Post-menopausal Inclusion Criteria:
Exclusion Criteria:
Post-Menopausal Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente, Dr. | proDERM GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proDERM GmbH | Hamburg | Pinneberg | 22869 | Germany |
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| ID | Term |
|---|---|
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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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.
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| 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. |
|
| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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| 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. |
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Overall proportion of subjects with Adverse Events/Adverse Device Effects (AE/ADEs) i.e. the occurrence of one of more AE/ADE per subject. |
| 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 | 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 | 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. | 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 | 24 hours post single application. |
| Global Assessment of Tolerance for each subject by a Gynaecologist | Determined by professional assessment of each individual. | 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 | 24 hours post single application |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |