Breast cancer patients on endocrine therapy (AI or SERM) with symptoms of vulvovaginal atrophy
Conditions
Brief summary
The primary endpoint of this study is the efficacy of the implemented treatment regimes. Efficacy will be assessed based on patient-reported outcome measurements, being two validated questionnaires: EQ5D-questionnaire (Appendix 1) and the FACT-ES questionnaire (Appendix 2). This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks).
Detailed description
The secondary endpoint is the safety of the implemented treatments. As a surrogate for safety, blood serum concentration of sex steroid hormones will be determined. This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks).
Interventions
DRUGOekolp 0
DRUG03 mg
DRUGovules
DRUGGynoflor Vaginaltabletten
DRUGIntrarosa 6.5 mg pessary.
DRUGGynoflor tabletten voor vaginaal gebruik
DRUGGynoflor comprimés vaginaux
Sponsors
Universitair Ziekenhuis Gent
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of this study is the efficacy of the implemented treatment regimes. Efficacy will be assessed based on patient-reported outcome measurements, being two validated questionnaires: EQ5D-questionnaire (Appendix 1) and the FACT-ES questionnaire (Appendix 2). This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is the safety of the implemented treatments. As a surrogate for safety, blood serum concentration of sex steroid hormones will be determined. This endpoint will be assessed at three time points: at start, after 6 weeks, and at the end (after 12 weeks). | — |
Countries
Belgium
Outcome results
None listed