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

Dr. August Wolff

Status

Completed

Conditions

Vulvovaginal Atrophy

Treatments

Device: WO2085 Moisturising Cream

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03593122

VFAU-13/2009

Details and patient eligibility

About

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

Full 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.

Enrollment

128 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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