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

Vulvovaginal Atrophy Clinical Trial

Official title:

Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03593122
• Other study ID #: VFAU-13/2009
• Status: Completed
• Phase: N/A
• Start date: January 4, 2010
• Est. completion date: July 31, 2010

Study information

• Verified date: July 2018
• Source: Dr. August Wolff GmbH & Co. KG Arzneimittel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: July 31, 2010
• Est. primary completion date: July 31, 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrophy
• Vulvovaginal Atrophy

Intervention

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).

Locations

Country	Name	City	State
Germany	Axel Gerick	Aachen
Germany	Sibylle Kaßpohl	Alzenau
Germany	Alexandra Coumbos	Berlin
Germany	Axel Widing	Berlin
Germany	Jörg Schilling	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

Sponsors (4)

Lead Sponsor	Collaborator
Dr. August Wolff GmbH & Co. KG Arzneimittel	Dr. Dimitrios Chatsiproios, Dr. med. Klaus König, SAM®, Statistische Analysen und Monitoring GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	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.	4 weeks
Secondary	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
Secondary	Adverse Events	Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).	after 4 weeks