Investigation of Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness

Prospective, Open-label Trial Investigating the Efficacy and Tolerability of WO 2707, a MoistCream Cremolum, in Postmenopausal Women Suffering From Symptoms of Vaginal Dryness

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.

Study Overview

• Status: Completed
• Conditions: Vaginal Atrophy
• Intervention / Treatment: Device: WO 2707

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Schenefeld, Germany
    • proDERM GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: WO 2707; Formulation containing WO 2707 for intravaginal application	Device: WO 2707; Intravaginal application once daily for 1 week, then twice per week until visit 3 (day 38).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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 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)

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: proDERM GmbH
• Investigators: Principal Investigator: Kirstin Deuble-Bente, MD, proderm GmbH, Germany

Study record dates

Study Major Dates

• Study Start (Actual): January 31, 2022
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: January 13, 2022
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 26, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: VFCrC-01/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No