Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness

Dr. August Wolff GmbH & Co. KG Arzneimittel128 enrolled

Overview

The aim of the study is to gain further experience with regard to the performance of the medical device WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors

The goal of this application study was to answer the question as to whether the application of WO2085 Moisturising Cream for breast cancer patients undergoing chemotherapy or treatment with anti-oestrogens / aromatase inhibitors can result in an improvement in the subjective symptoms and objective diagnoses of vulvovaginal dryness while also ensuring good tolerability.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

128

Conditions

Vulvovaginal Atrophy

Interventions

WO2085 Moisturising CreamDEVICE

Week 1: 2.5 g of the investigational product WO2085 Moisturising Cream will be applied intravaginally, once daily in the evening. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day). Week 2-4: The frequency may be reduced by the patient as needed. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women with breast cancer undergoing chemotherapy OR therapy with aromatase inhibitors or anti-oestrogens (either at present or up to 3 months after ending treatment) AND with symptoms of vulvovaginal dryness since the start of tumour treatment * Written declaration of consent for the voluntary participation in the study is present Exclusion Criteria: * Women who suffered symptoms of vulvovaginal dryness prior to the start of tumour treatment * Patients undergoing radiation therapy * Patients with other tumours * A current vaginal infection * Medical conditions related to the vulva or vagina * Current additional therapy of vulvovaginal dryness or vulvovaginal atrophy * Women who are not able to participate properly in this study * Current alcohol and/or drug abuse * Pregnant or lactating women

Locations (17)

Axel Gerick

Aachen, Germany

Sibylle Kaßpohl

Alzenau in Unterfranken, Germany

Jörg Schilling

Berlin, Germany

Outcomes

Primary Outcomes

Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)

Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced)

Time frame: Baseline, after 4 weeks

Secondary Outcomes

Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)

Each symptom is rated according to severity on a scale from 0 to 4 (0=not present, 1=hardly pronounced, 2=moderately pronounced, 3=quite pronounced, 4=very pronounced)

Time frame: 4 weeks

Global judgement of efficacy

The global judgement of efficacy will be assessed by the investigator and the patient according to the following scale: 1=very good to 6=unsatisfactory.

Time frame: 4 weeks

Global judgement of tolerability

The global judgement of tolerability will be assessed by the investigator and the patient according to the following scale: 1=very good to 6=unsatisfactory.

Time frame: 4 weeks

Adverse Events

Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).

Time frame: after 4 weeks

Data from ClinicalTrials.gov

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