Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
- Conditions
- Vaginal Atrophy
- Interventions
- Device: WO 2707
- Registration Number
- NCT05211505
- Lead Sponsor
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 79
-
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
-
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
- Vaginal inflammation which is not caused by vulvovaginal atrophy
- Non-healed vaginal surgery
- 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
- Local hormonal therapy (vagina/vulva) within 3 months before Screening (also when used for the brightening/pretreatment of cytological smears)
- 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)
- Systemic corticosteroids within 21 days before visit 1 (day 1) and during the conduct of this clinical investigation (corticoid asthma sprays are allowed)
- 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
- Known hypersensitivity against any of the ingredients of the investigational medical device
- Employees of the investigation sites who are directly involved in this clinical investigation or employees of the sponsor's company
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description WO 2707 WO 2707 Formulation containing WO 2707 for intravaginal application
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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 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 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
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)
Trial Locations
- Locations (1)
proderm GmbH
🇩🇪Schenefeld, Germany