Back to resultsInvestigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
Primary Purpose
Vaginal Atrophy
Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
WO 2707
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Atrophy
Eligibility Criteria
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)
- 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
Exclusion Criteria:
- 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
Sites / Locations
- proderm GmbH
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
WO 2707
Arm Description
Formulation containing WO 2707 for intravaginal application
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
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
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).
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).
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)
Change of vaginal pH
Patient questionnaire
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
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).
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
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
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
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
Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication
Full Information
NCT ID
NCT05211505
First Posted
January 13, 2022
Last Updated
April 26, 2022
Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
proDERM GmbH
1. Study Identification
Unique Protocol Identification Number
NCT05211505
Brief Title
Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
Official Title
Prospective, Open-label Trial Investigating the Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
March 24, 2022 (Actual)
Study Completion Date
March 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
proDERM GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
79 (Actual)
8. Arms, Groups, and Interventions
Arm Title
WO 2707
Arm Type
Experimental
Arm Description
Formulation containing WO 2707 for intravaginal application
Intervention Type
Device
Intervention Name(s)
WO 2707
Intervention Description
Intravaginal application once daily for 1 week, then twice per week until visit 3 (day 38).
Primary Outcome Measure Information:
Title
Change of TSS (Total severity score) for subjective symptoms of atrophy
Description
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).
Time Frame
From baseline to visit 3 (day 38)
Secondary Outcome Measure Information:
Title
Change of TSS (Total severity score) for subjective symptoms of atrophy
Description
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).
Time Frame
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)
Title
Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse)
Description
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
Time Frame
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)
Title
Change of each DIVA domain score (A - D) and change of total DIVA score (excluding questions 12 to 15)
Description
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).
Time Frame
From baseline to visit 3 (day 38)
Title
Change of each DIVA domain score (A - D) and change of total DIVA score in the subgroup of sexually active women with dyspareunia
Description
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).
Time Frame
From baseline to visit 3 (day 38)
Title
Change of each single parameter and of sum score over objective assessment of VHI
Description
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)
Time Frame
From baseline to visit 3 (day 38)
Title
Change of vaginal pH
Time Frame
From baseline to visit 3 (day 38)
Title
Patient questionnaire
Time Frame
Day 3, visit 3 (day 38), visit 4 (day 44)
Title
Change of severity scoring for dyspareunia for the subgroup of sexually active women with dyspareunia
Description
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
Time Frame
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)
Title
Change of impairment of daily life due to dyspareunia (VAS) for the subgroup of sexually active women with dyspareunia
Description
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).
Time Frame
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)
Title
Global judgement of efficacy by the investigator
Description
The global judgement of efficacy will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor
Time Frame
On visit 3 (day 38)
Title
Global judgement of efficacy by the patient
Description
The global judgement of efficacy will be assessed according to the following scale: 1=very good,2=good, 3=moderate, 4=poor
Time Frame
On visit 3 (day 38)
Title
Global judgement of tolerability by the investigator
Description
The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate, 4=poor
Time Frame
On visit 3 (day 38)
Title
Global judgement of tolerability by the patient
Description
The global judgement of tolerability will be assessed according to the following scale: 1=very good, 2=good, 3=moderate,4=poor
Time Frame
On visit 3 (day 38)
Title
Participants with premature trial termination due to adverse device effects, adverse events, concomitant medication
Time Frame
From baseline to visit 4 (day 44)
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Participant eligibility based on self-representation of gender identity.
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kirstin Deuble-Bente, MD
Organizational Affiliation
proderm GmbH, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
proderm GmbH
City
Schenefeld
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness
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