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Completed

NCT Number: NCT03593122

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

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

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Key information

Conditions

Vulvovaginal Atrophy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Axel Gerick, Aachen, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. Global judgement of efficacy

    Time frame: 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.

  3. Global judgement of tolerability

    Time frame: 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.

  4. Adverse Events

    Time frame: after 4 weeks

    Adverse events will be documented on Visit after 4 weeks (and in the patient diary, if applicable).

Sponsors and collaborators

Lead sponsor

Dr. August Wolff GmbH & Co. KG Arzneimittel

Industry

Collaborators

  • Dr. Dimitrios Chatsiproios
  • Dr. med. Klaus König
  • SAM®, Statistische Analysen und Monitoring GmbH

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jul 19, 2018
Registry last updated
Jul 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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