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| Name | Class |
|---|---|
| Dr. Dimitrios Chatsiproios | UNKNOWN |
| Dr. med. Klaus König | UNKNOWN |
| SAM®, Statistische Analysen und Monitoring GmbH | UNKNOWN |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WO 2085 Moisturising Cream | Experimental | WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WO2085 Moisturising Cream | Device | 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Christoph Abels, MD, PhD | Dr. August Wolff GmbH & Co. KG Arzneimittel | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Axel Gerick | Aachen | 52072 | Germany | |||
| Sibylle Kaßpohl |
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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 |
| Alzenau in Unterfranken |
| 63755 |
| Germany |
| Jörg Schilling | Berlin | 10317 | Germany |
| Axel Widing | Berlin | 12107 | Germany |
| Alexandra Coumbos | Berlin | 12167 | Germany |
| Amin Mortazawi | Darmstadt | 64287 | Germany |
| Kathrin von Ardenne | Dresden | 01326 | Germany |
| Joachim Larbig | Fulda | 36037 | Germany |
| Nidal Gazawi | Leipzig | 04107 | Germany |
| Elke Wierick | Lohsa | 02999 | Germany |
| Dagmar Guth | Plauen | 08525 | Germany |
| Wolfgang Clemens | Stolberg | 52222 | Germany |
| Carsten Hielscher | Stralsund | 18435 | Germany |
| Christopher Wolf | Ulm | 89073 | Germany |
| Heidi Massinger-Biebl | Waldkirchen | 94065 | Germany |
| Klaus Doubek | Wiesbaden | 65185 | Germany |
| Anja Obermeyer | Würselen | Germany |