Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness
NCT ID: NCT03593122
Last Updated: 2018-07-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2010-01-04
2010-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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WO 2085 Moisturising Cream
WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* Written declaration of consent for the voluntary participation in the study is present
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Dr. Dimitrios Chatsiproios
UNKNOWN
Dr. med. Klaus König
UNKNOWN
SAM®, Statistische Analysen und Monitoring GmbH
UNKNOWN
Dr. August Wolff GmbH & Co. KG Arzneimittel
INDUSTRY
Responsible Party
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Principal Investigators
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Prof. Christoph Abels, MD, PhD
Role: STUDY_DIRECTOR
Dr. August Wolff GmbH & Co. KG Arzneimittel
Locations
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Axel Gerick
Aachen, , Germany
Sibylle Kaßpohl
Alzenau in Unterfranken, , Germany
Jörg Schilling
Berlin, , Germany
Axel Widing
Berlin, , Germany
Alexandra Coumbos
Berlin, , Germany
Amin Mortazawi
Darmstadt, , Germany
Kathrin von Ardenne
Dresden, , Germany
Joachim Larbig
Fulda, , Germany
Nidal Gazawi
Leipzig, , Germany
Elke Wierick
Lohsa, , Germany
Dagmar Guth
Plauen, , Germany
Wolfgang Clemens
Stolberg, , Germany
Carsten Hielscher
Stralsund, , Germany
Christopher Wolf
Ulm, , Germany
Heidi Massinger-Biebl
Waldkirchen, , Germany
Klaus Doubek
Wiesbaden, , Germany
Anja Obermeyer
Würselen, , Germany
Countries
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Other Identifiers
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VFAU-13/2009
Identifier Type: -
Identifier Source: org_study_id
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