estriol for Breast cancer | Vulvovaginal atrophy

Inclusion criteria

• {"criterion_text":"- Breast cancer patient"}
• {"criterion_text":"- Current endocrine therapy (AI or SERM)"}
• {"criterion_text":"- Postmenopausal status, defined by: 12 months amenorrhoe or 6 months amenorrhoe and FSH level of >40 mIU/mL or Induced postmenopause (ovarian function suppression using GnRH-analogue) >6 weeks after bilateral oophorectomy or"}
• {"criterion_text":"- Presence of one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation)"}

Exclusion criteria

• {"criterion_text":"- A history of vulvar or vaginal surgery. Inclusion is possible after hysterectomy. For these subjects no microbiome sampling will be performed. Microbiome analysis is not performed for these subjects."}
• {"criterion_text":"- Current other vulvar or vaginal disease (e.g. dysplasia, fungal infection,…)"}
• {"criterion_text":"- Recent use of antibiotics/antifungals/corticosteroids (less than 1 month)"}
• {"criterion_text":"- Current use of vaginal hormonal treatment or vaginal moisturizer (inclusion is possible after a washout period of 4 weeks)"}

Primary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Efficacy assessed by patient-reported outcome measurements: EQ-5D questionnaire and FACT-ES questionnaire at baseline, 6 weeks and 12 weeks."}

Secondary endpoints

• {"endpoint_text":"- 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).","definition_or_measurement_approach":"Safety assessed by measuring blood serum concentrations of sex steroid hormones at baseline, 6 weeks and 12 weeks."}

Other endpoints

• {"endpoint_text":"- The secondary objective in this study is the identification of microbial alterations after treatment initiation. Identification of these alterations can help in further understanding of the pathophysiology of vulvovaginal atrophy and potentially create opportunities for new treatment strategies towards vulvovaginal atrophy in breast cancer patients on endocrine therapy.","definition_or_measurement_approach":"Identification and analysis of microbial alterations (microbiome) after treatment initiation (microbiome sampling and analysis); note microbiome sampling not performed for subjects with prior vulvar/vaginal surgery."}

Methods

• Poster/flyer (document: K2_POSTERFLYER_for publication) - recruitment material present (target: eligible breast cancer patients); country context: Belgium
• Advertisement material (document: K3_Probando advertisement material) - recruitment advertisement material present (target: eligible breast cancer patients); country context: Belgium
• Subject cards for each product in Dutch (documents: D2_Subject card NL_Premeno, D2_Subject card NL_Gynoflor, D2_Subject card NL_Oekolp, D2_Subject card NL_Intrarosa) - patient-facing information/recall cards (language: Dutch)

Belgium

Earliest CTIS Part Ii Submission Date

22-05-2024

Latest Decision Or Authorization Date

20-06-2025

Processing Time Days

394

Number Of Sites

1

Number Of Participants

190

Primary sponsor

Full Name

Universitair Ziekenhuis Gent

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Belgium