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

NCT03593122 | Completed

• 1 other identifier: VFAU-13/2009
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 17

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

Conditions

Vulvovaginal Atrophy

Keywords

Vulvovaginal Dryness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)

  4 weeks

• Global judgement of efficacy

  4 weeks

• Global judgement of tolerability

  4 weeks

• Adverse Events

  after 4 weeks

Study Arms (1)

WO 2085 Moisturising Cream

EXPERIMENTAL

WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.

Device: WO2085 Moisturising Cream

Interventions

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).

WO 2085 Moisturising Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. August Wolff GmbH & Co. KG Arzneimittel: lead
• Dr. Dimitrios Chatsiproios: collaborator
• Dr. med. Klaus König: collaborator
• SAM®, Statistische Analysen und Monitoring GmbH: collaborator

Study Sites (17)

Axel Gerick

Aachen, 52072, Germany

Location

Sibylle Kaßpohl

Alzenau in Unterfranken, 63755, Germany

Location

Jörg Schilling

Berlin, 10317, Germany

Location

Axel Widing

Berlin, 12107, Germany

Location

Alexandra Coumbos

Berlin, 12167, Germany

Location

Amin Mortazawi

Darmstadt, 64287, Germany

Location

Kathrin von Ardenne

Dresden, 01326, Germany

Location

Joachim Larbig

Fulda, 36037, Germany

Location

Nidal Gazawi

Leipzig, 04107, Germany

Location

Elke Wierick

Lohsa, 02999, Germany

Location

Dagmar Guth

Plauen, 08525, Germany

Location

Wolfgang Clemens

Stolberg, 52222, Germany

Location

Carsten Hielscher

Stralsund, 18435, Germany

Location

Christopher Wolf

Ulm, 89073, Germany

Location

Heidi Massinger-Biebl

Waldkirchen, 94065, Germany

Location

Klaus Doubek

Wiesbaden, 65185, Germany

Location

Anja Obermeyer

Würselen, Germany

Location

Study Officials

• Prof. Christoph Abels, MD, PhD

  Dr. August Wolff GmbH & Co. KG Arzneimittel

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2018
• First Posted: July 19, 2018
• Study Start: January 4, 2010
• Primary Completion: July 31, 2010
• Study Completion: July 31, 2010
• Last Updated: July 19, 2018

Record last verified: 2018-07

Locations

DE (17)