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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03593122
Recruitment Status : Completed
First Posted : July 19, 2018
Last Update Posted : July 19, 2018
Sponsor:
Collaborators:
Dr. Dimitrios Chatsiproios
Dr. med. Klaus König
SAM®, Statistische Analysen und Monitoring GmbH
Information provided by (Responsible Party):
Dr. August Wolff GmbH & Co. KG Arzneimittel

Study Description
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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

Condition or disease Intervention/treatment Phase
Vulvovaginal Atrophy Device: WO2085 Moisturising Cream Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness
Actual Study Start Date : January 4, 2010
Actual Primary Completion Date : July 31, 2010
Actual Study Completion Date : July 31, 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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).


Outcome Measures
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Primary Outcome Measures :
  1. Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching) [ Time Frame: Baseline, after 4 weeks ]
    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 :
  1. Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness) [ Time Frame: 4 weeks ]
    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)

  2. Global judgement of efficacy [ Time Frame: 4 weeks ]
    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.

  3. Global judgement of tolerability [ Time Frame: 4 weeks ]
    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. Adverse Events [ Time Frame: after 4 weeks ]
    Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593122


Locations
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Sponsors and Collaborators
Dr. August Wolff GmbH & Co. KG Arzneimittel
Dr. Dimitrios Chatsiproios
Dr. med. Klaus König
SAM®, Statistische Analysen und Monitoring GmbH
Investigators
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Study Director: Prof. Christoph Abels, MD, PhD Dr. August Wolff GmbH & Co. KG Arzneimittel
More Information
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Responsible Party: Dr. August Wolff GmbH & Co. KG Arzneimittel
ClinicalTrials.gov Identifier: NCT03593122    
Other Study ID Numbers: VFAU-13/2009
First Posted: July 19, 2018    Key Record Dates
Last Update Posted: July 19, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. August Wolff GmbH & Co. KG Arzneimittel:
Vulvovaginal Dryness
Additional relevant MeSH terms:
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Atrophy
Pathological Conditions, Anatomical