Vaginal Atrophy
Conditions
Brief summary
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.
Interventions
DEVICEWO 2707
Intravaginal application once daily for 1 week, then twice per week until visit 3 (day 38).
Sponsors
proDERM GmbH
Dr. August Wolff GmbH & Co. KG Arzneimittel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 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) * Thereof at least for 48 included patients: sexual activity with dyspareunia * Thereof at least 32 included sexually active patients with at least moderate (score of 2) dyspareunia 2. Natural cessation of last menstruation more than 12 months before screening OR bilateral oophorectomy with or without hysterectomy more than 3 months before screening 3. Signed written informed consent before participation in the clinical investigation
Exclusion criteria
1. Vaginal inflammation which is not caused by vulvovaginal atrophy 2. Non-healed vaginal surgery 3. Systemic hormonal replacement therapy (tablets, patches, injections, dermal products), or phytohormonal therapy or use of SERMs (selective estrogen receptor modulators) within 3 months before visit 1 (day 1) and / or during the conduct of this clinical investigation 4. Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears) 5. Any use of products (including lubricants), other than the investigational medicinal device, applied intravaginally or on the vulva during the clinical investigation (except usual cleansing products) 6. Systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed) 7. Use of antibiotics, antiseptics or antimycotics with expected or suspected systemic or vaginal/vulvar bioavailability within 21 days before visit 1 (day 1) and / or during this clinical investigation 8. Known hypersensitivity against any of the ingredients of the investigational medical device 9. Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of TSS (Total severity score) for subjective symptoms of atrophy | From baseline to visit 3 (day 38) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse) | 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) | 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 |
| Change of each DIVA domain score (A - D) and change of total DIVA score (excluding questions 12 to 15) | From baseline to visit 3 (day 38) | 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). |
| Change of each DIVA domain score (A - D) and change of total DIVA score in the subgroup of sexually active women with dyspareunia | From baseline to visit 3 (day 38) | 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). |
| Change of each single parameter and of sum score over objective assessment of VHI | From baseline to visit 3 (day 38) | 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) |
| 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 TSS (Total severity score) for subjective symptoms of atrophy | 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) | 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). |
| Change of impairment of daily life due to dyspareunia (VAS) for the subgroup of sexually active women with dyspareunia | 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) | 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). |
| Global judgement of efficacy by the investigator | On visit 3 (day 38) | The global judgement of efficacy will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor |
| Global judgement of efficacy by the patient | On visit 3 (day 38) | The global judgement of efficacy will be assessed according to the following scale: 1=very good,2=good, 3=moderate, 4=poor |
| Global judgement of tolerability by the investigator | On visit 3 (day 38) | The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor |
| Global judgement of tolerability by the patient | On visit 3 (day 38) | The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate,4=poor |
| Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication | From baseline to visit 4 (day 44) | — |
| Change of severity scoring for dyspareunia for the subgroup of sexually active women with dyspareunia | 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) | 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 |
Countries
Germany
Outcome results
None listed