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| Name | Class |
|---|---|
| proDERM GmbH | INDUSTRY |
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The objective of the clinical investigation is to evaluate the efficacy and tolerability of WO 2707, a MoistCream Cremolum, with respect to the application in postmenopausal women with symptoms of vaginal dryness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WO 2707 | Experimental | Formulation containing WO 2707 for intravaginal application |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WO 2707 | Device | Intravaginal application once daily for 1 week, then twice per week until visit 3 (day 38). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change of TSS (Total severity score) for subjective symptoms of atrophy | The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe The total severity score will be calculated as the sum score of the subjective symptoms resulting in a minimum score of 0 (best) and a maximal score of 16 (worst). | From baseline to visit 3 (day 38) |
| Measure | Description | Time Frame |
|---|---|---|
| Change of TSS (Total severity score) for subjective symptoms of atrophy | The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe The total severity score will be calculated as the sum score of the subjective symptoms resulting in a minimum score of 0 (best) and a maximal score of 16 (worst). |
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Inclusion Criteria:
Post-menopausal women with the subjective symptomatology of vulvovaginal atrophy with a sum score (0-16) of the parameters dryness, itching, burning and pain unrelated to sexual intercourse of at least 3 AND a score of at least "2" (moderate) for the parameter dryness at screening and visit 1 (day 1)
Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening
Signed written informed consent before participation in the clinical investigation
Exclusion Criteria:
Participant eligibility based on self-representation of gender identity.
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| Name | Affiliation | Role |
|---|---|---|
| Kirstin Deuble-Bente, MD | proderm GmbH, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| proderm GmbH | Schenefeld | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38583316 | Derived | Eichler S, Panz M, Harder A, Masur C, Hauser M, Wiesche ESZ. An effective non-hormonal option with high tolerability for mild to moderate symptoms of vaginal dryness associated with menopause. Maturitas. 2024 Jul;185:107978. doi: 10.1016/j.maturitas.2024.107978. Epub 2024 Mar 29. | |
| 36787527 | Derived | Gabes M, Donhauser T, Harder A, Masur C, Apfelbacher CJ. Psychometric evaluation of the German Day-to-Day Impact of Vaginal Aging questionnaire using data from two intervention studies. Menopause. 2023 May 1;30(5):551-555. doi: 10.1097/GME.0000000000002161. Epub 2023 Feb 14. |
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| From baseline to visit 2 (day 8), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44) |
| Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) | The severity of each of the subjective symptoms dryness, itching, burning and pain unrelated to sexual intercourse will be assessed according to the following scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=very severe | From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44) |
| Change of each DIVA domain score (A - D) and change of total DIVA score (excluding questions 12 to 15) | The DIVA questionnaire addresses the impact of vaginal symptoms such as vaginal dryness, soreness, irritation and itching on the day-to-day life regarding the patient's activities, relationships, and feelings by any of these symptoms (Huang, 2015; Gabes, 2021). | From baseline to visit 3 (day 38) |
| Change of each DIVA domain score (A - D) and change of total DIVA score in the subgroup of sexually active women with dyspareunia | The DIVA questionnaire addresses the impact of vaginal symptoms such as vaginal dryness, soreness, irritation and itching on the day-to-day life regarding the patient's activities, relationships, and feelings by any of these symptoms (Huang, 2015; Gabes, 2021). | From baseline to visit 3 (day 38) |
| Change of each single parameter and of sum score over objective assessment of VHI | The objective status of the vagina will be assessed by the Investigator according to the Vaginal Health Index (Bachmann, 1995). Each of the five criteria - elasticity, fluid secretion, pH, epithelial mucosa and moisture - will be graded from 1 (worst) to 5 (best) and will then be summed up, so that the minimum score will be 5 (worst) and the maximum score will be 25 (best) | From baseline to visit 3 (day 38) |
| Change of vaginal pH | From baseline to visit 3 (day 38) |
| Patient questionnaire | Day 3, visit 3 (day 38), visit 4 (day 44) |
| Change of severity scoring for dyspareunia for the subgroup of sexually active women with dyspareunia | Severity scoring for Dyspareunia will be assessed by the patients according to the following scale: 0=none,1=mild, 2=moderate, 3=severe, 4=very severe | From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44) |
| Change of impairment of daily life due to dyspareunia (VAS) for the subgroup of sexually active women with dyspareunia | Impairment of daily life due to dyspareunia will be assessed using a 10 cm visual analogue scale (VAS) ranging from 0 (no impairment) to 10 (very pronounced impairment). | From baseline to visit 2 (day 8) and visit 3 (day 38), visit 2 (day 8) to visit 3 (day 38) and visit 3 (day 38) to visit 4 (day 44) |
| Global judgement of efficacy by the investigator | The global judgement of efficacy will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor | On visit 3 (day 38) |
| Global judgement of efficacy by the patient | The global judgement of efficacy will be assessed according to the following scale: 1=very good,2=good, 3=moderate, 4=poor | On visit 3 (day 38) |
| Global judgement of tolerability by the investigator | The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor | On visit 3 (day 38) |
| Global judgement of tolerability by the patient | The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate,4=poor | On visit 3 (day 38) |
| Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication | From baseline to visit 4 (day 44) |