Clinical trial NCT03593122: Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness
Official title: Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vulvovaginal Atrophy
Keywords: Vulvovaginal Dryness
Lead sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
Sponsor class: INDUSTRY
Collaborators: name: Dr. Dimitrios Chatsiproios
name: Dr. med. Klaus König
name: SAM®, Statistische Analysen und Monitoring GmbH
First posted: 2018-07-19
Enrollment: 128
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)
timeFrame: Baseline, after 4 weeks
Secondary outcomes:
measure: Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)
timeFrame: 4 weeks
measure: Global judgement of efficacy
timeFrame: 4 weeks
measure: Global judgement of tolerability
timeFrame: 4 weeks
measure: Adverse Events
timeFrame: after 4 weeks
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Axel Gerick
city: Alzenau
country: Germany
facility: Sibylle Kaßpohl
city: Berlin
country: Germany
facility: Jörg Schilling
city: Berlin
country: Germany
facility: Axel Widing
city: Berlin
country: Germany
facility: Alexandra Coumbos
city: Darmstadt
country: Germany
facility: Amin Mortazawi
city: Dresden
country: Germany
facility: Kathrin von Ardenne
city: Fulda
country: Germany
facility: Joachim Larbig
city: Leipzig
country: Germany
facility: Nidal Gazawi
city: Lohsa
country: Germany
facility: Elke Wierick
city: Plauen
country: Germany
facility: Dagmar Guth
city: Stolberg
country: Germany
facility: Wolfgang Clemens
city: Stralsund
country: Germany
facility: Carsten Hielscher
city: Ulm
country: Germany
facility: Christopher Wolf
city: Waldkirchen
country: Germany
facility: Heidi Massinger-Biebl
city: Wiesbaden
country: Germany
facility: Klaus Doubek
city: Würselen
country: Germany
facility: Anja Obermeyer
Study officials:
affiliation: Dr. August Wolff GmbH & Co. KG Arzneimittel
name: Prof. Christoph Abels, MD, PhD
role: STUDY_DIRECTOR
References: