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

Dr. August Wolff GmbH & Co. KG Arzneimittel79 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Vaginal Atrophy

Interventions

WO 2707DEVICE

Intravaginal application once daily for 1 week, then twice per week until visit 3 (day 38).

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

proderm GmbH

Schenefeld, Germany

Outcomes

Primary Outcomes

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).

Time frame: From baseline to visit 3 (day 38)

Secondary Outcomes

Change of TSS (Total severity score) for subjective symptoms of atrophy

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)

Change of severity scoring for each of the subjective symptoms (dryness, itching, burning and pain unrelated to sexual intercourse)

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)

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).

Data from ClinicalTrials.gov

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