Symptoms and General Pathology

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Atrophy

Breast Neoplasms

Pathological Conditions, Anatomical

All Drugs and Chemicals

Hormones

WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.

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).

WO2085 Moisturising Cream

Prof. Christoph Abels, MD, PhD

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.

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

Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness

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)

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.

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.

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness	NCT03593122	Vulvovaginal At...	WO2085 Moisturi...	18 Years -	Dr. August Wolff GmbH & Co. KG Arzneimittel
Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness	NCT03593122	Vulvovaginal At...	WO2085 Moisturi...	18 Years -	Dr. August Wolff GmbH & Co. KG Arzneimittel

Spots Global Cancer Trial Database for vulvovaginal dryness