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

Primary Purpose

Vulvovaginal Atrophy

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
WO2085 Moisturising Cream
Sponsored by
Dr. August Wolff GmbH & Co. KG Arzneimittel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vulvovaginal Atrophy focused on measuring Vulvovaginal Dryness

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Axel Gerick
  • Sibylle Kaßpohl
  • Jörg Schilling
  • Axel Widing
  • Alexandra Coumbos
  • Amin Mortazawi
  • Kathrin von Ardenne
  • Joachim Larbig
  • Nidal Gazawi
  • Elke Wierick
  • Dagmar Guth
  • Wolfgang Clemens
  • Carsten Hielscher
  • Christopher Wolf
  • Heidi Massinger-Biebl
  • Klaus Doubek
  • Anja Obermeyer

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

WO 2085 Moisturising Cream

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
July 9, 2018
Last Updated
July 18, 2018
Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
Dr. Dimitrios Chatsiproios, Dr. med. Klaus König, SAM®, Statistische Analysen und Monitoring GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03593122
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2010 (Actual)
Primary Completion Date
July 31, 2010 (Actual)
Study Completion Date
July 31, 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dr. August Wolff GmbH & Co. KG Arzneimittel
Collaborators
Dr. Dimitrios Chatsiproios, Dr. med. Klaus König, SAM®, Statistische Analysen und Monitoring GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vulvovaginal Atrophy
Keywords
Vulvovaginal Dryness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WO 2085 Moisturising Cream
Arm Type
Experimental
Arm Description
WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
Intervention Type
Device
Intervention Name(s)
WO2085 Moisturising Cream
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)
Description
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 Outcome Measure Information:
Title
Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)
Description
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
Title
Global judgement of efficacy
Description
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
Title
Global judgement of tolerability
Description
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
Title
Adverse Events
Description
Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).
Time Frame
after 4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Christoph Abels, MD, PhD
Organizational Affiliation
Dr. August Wolff GmbH & Co. KG Arzneimittel
Official's Role
Study Director
Facility Information:
Facility Name
Axel Gerick
City
Aachen
ZIP/Postal Code
52072
Country
Germany
Facility Name
Sibylle Kaßpohl
City
Alzenau
ZIP/Postal Code
63755
Country
Germany
Facility Name
Jörg Schilling
City
Berlin
ZIP/Postal Code
10317
Country
Germany
Facility Name
Axel Widing
City
Berlin
ZIP/Postal Code
12107
Country
Germany
Facility Name
Alexandra Coumbos
City
Berlin
ZIP/Postal Code
12167
Country
Germany
Facility Name
Amin Mortazawi
City
Darmstadt
ZIP/Postal Code
64287
Country
Germany
Facility Name
Kathrin von Ardenne
City
Dresden
ZIP/Postal Code
01326
Country
Germany
Facility Name
Joachim Larbig
City
Fulda
ZIP/Postal Code
36037
Country
Germany
Facility Name
Nidal Gazawi
City
Leipzig
ZIP/Postal Code
04107
Country
Germany
Facility Name
Elke Wierick
City
Lohsa
ZIP/Postal Code
02999
Country
Germany
Facility Name
Dagmar Guth
City
Plauen
ZIP/Postal Code
08525
Country
Germany
Facility Name
Wolfgang Clemens
City
Stolberg
ZIP/Postal Code
52222
Country
Germany
Facility Name
Carsten Hielscher
City
Stralsund
ZIP/Postal Code
18435
Country
Germany
Facility Name
Christopher Wolf
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Heidi Massinger-Biebl
City
Waldkirchen
ZIP/Postal Code
94065
Country
Germany
Facility Name
Klaus Doubek
City
Wiesbaden
ZIP/Postal Code
65185
Country
Germany
Facility Name
Anja Obermeyer
City
Würselen
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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