Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness
Study Details
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching) [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
- Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness) [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)
- Global judgement of efficacy [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.
- Global judgement of tolerability [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.
- Adverse Events [after 4 weeks]
Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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Written declaration of consent for the voluntary participation in the study is present
Exclusion Criteria:
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Women who suffered symptoms of vulvovaginal dryness prior to the start of tumour treatment
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Patients undergoing radiation therapy
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Patients with other tumours
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A current vaginal infection
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Medical conditions related to the vulva or vagina
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Current additional therapy of vulvovaginal dryness or vulvovaginal atrophy
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Women who are not able to participate properly in this study
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Current alcohol and/or drug abuse
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Pregnant or lactating women
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Axel Gerick | Aachen | Germany | 52072 | |
| 2 | Sibylle Kaßpohl | Alzenau | Germany | 63755 | |
| 3 | Jörg Schilling | Berlin | Germany | 10317 | |
| 4 | Axel Widing | Berlin | Germany | 12107 | |
| 5 | Alexandra Coumbos | Berlin | Germany | 12167 | |
| 6 | Amin Mortazawi | Darmstadt | Germany | 64287 | |
| 7 | Kathrin von Ardenne | Dresden | Germany | 01326 | |
| 8 | Joachim Larbig | Fulda | Germany | 36037 | |
| 9 | Nidal Gazawi | Leipzig | Germany | 04107 | |
| 10 | Elke Wierick | Lohsa | Germany | 02999 | |
| 11 | Dagmar Guth | Plauen | Germany | 08525 | |
| 12 | Wolfgang Clemens | Stolberg | Germany | 52222 | |
| 13 | Carsten Hielscher | Stralsund | Germany | 18435 | |
| 14 | Christopher Wolf | Ulm | Germany | 89073 | |
| 15 | Heidi Massinger-Biebl | Waldkirchen | Germany | 94065 | |
| 16 | Klaus Doubek | Wiesbaden | Germany | 65185 | |
| 17 | Anja Obermeyer | Würselen | Germany |
Sponsors and Collaborators
- Dr. August Wolff GmbH & Co. KG Arzneimittel
- 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 Documents (Full-Text)
None provided.More Information
Publications
None provided.- VFAU-13/2009