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

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

Study Overview

• Status: Completed
• Conditions: Vulvovaginal Atrophy
• Intervention / Treatment: Device: WO2085 Moisturising Cream

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Aachen, Germany, 52072
    • Axel Gerick
  • Alzenau, Germany, 63755
    • Sibylle Kaßpohl
  • Berlin, Germany, 10317
    • Jörg Schilling
  • Berlin, Germany, 12107
    • Axel Widing
  • Berlin, Germany, 12167
    • Alexandra Coumbos
  • Darmstadt, Germany, 64287
    • Amin Mortazawi
  • Dresden, Germany, 01326
    • Kathrin von Ardenne
  • Fulda, Germany, 36037
    • Joachim Larbig
  • Leipzig, Germany, 04107
    • Nidal Gazawi
  • Lohsa, Germany, 02999
    • Elke Wierick
  • Plauen, Germany, 08525
    • Dagmar Guth
  • Stolberg, Germany, 52222
    • Wolfgang Clemens
  • Stralsund, Germany, 18435
    • Carsten Hielscher
  • Ulm, Germany, 89073
    • Christopher Wolf
  • Waldkirchen, Germany, 94065
    • Heidi Massinger-Biebl
  • Wiesbaden, Germany, 65185
    • Klaus Doubek
  • Würselen, Germany
    • Anja Obermeyer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: WO 2085 Moisturising Cream; WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.

Device: WO2085 Moisturising Cream; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Baseline, after 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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.	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.	4 weeks
Adverse Events	Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).	after 4 weeks

Collaborators and Investigators

• Sponsor: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Collaborators: Dr. Dimitrios Chatsiproios; Dr. med. Klaus König; SAM®, Statistische Analysen und Monitoring GmbH
• Investigators: Study Director: Prof. Christoph Abels, MD, PhD, Dr. August Wolff GmbH & Co. KG Arzneimittel

Study record dates

Study Major Dates

• Study Start (Actual): January 4, 2010
• Primary Completion (Actual): July 31, 2010
• Study Completion (Actual): July 31, 2010

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 18, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): July 19, 2018
• Last Update Submitted That Met QC Criteria: July 18, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Vulvovaginal Dryness
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Atrophy
• Other Study ID Numbers: VFAU-13/2009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No