Clinical trial · Interventional
Investigation on the Efficacy of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From Vulvovaginal Dryness
Multicentric Study on the Application of WO 2085 Moisturising Cream for Breast Cancer Patients Suffering From the Symptoms of Vulvovaginal Dryness
NCT03593122CI-TRIAL-00033860completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvovaginal Atrophy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| WO2085 Moisturising Cream | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- WO 2085 Moisturising Cream
- description
- WO2085 is a hormone-free Moisturizing Cream and is used to treat "vulvovaginal dryness" symptoms.
- interventionNames
- Device: WO2085 Moisturising Cream
Primary outcomes (1)
- measure
- Change from Baseline of subjective vulvovaginal atrophy symptoms (e.g. feeling of dryness, itching)
- timeFrame
- Baseline, after 4 weeks
- description
- 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 (4)
- measure
- Change from Baseline of objective vulvovaginal atrophy symptoms (e.g. thinning of the vaginal epithelium, redness)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.