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

NCT03593122 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-07-19

No results posted yet for this study

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

Interventions

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).

Sponsors & Collaborators

  • Dr. Dimitrios Chatsiproios

    collaborator UNKNOWN

  • Dr. med. Klaus König

    collaborator UNKNOWN

  • SAM®, Statistische Analysen und Monitoring GmbH

    collaborator UNKNOWN

  • Dr. August Wolff GmbH & Co. KG Arzneimittel

    lead INDUSTRY

Principal Investigators

  • Prof. Christoph Abels, MD, PhD · Dr. August Wolff GmbH & Co. KG Arzneimittel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-04
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03593122 on ClinicalTrials.gov