BridgeMD
A randomized active-controlled trial for vulvovaGinal atRophy in breAst Cancer patients on Endocrine therapy (GRACE-trial)
EU CTIS ID: 2024-510845-33-00
What this study is testing
In this active-controlled randomized trial two main primary objectives have been determined. Firstly, the efficacy of the different treatment regimens will be assessed. The assessment will be based on PROMs and clinical evaluations such as vaginal pH and the vaginal maturation index, the latter a direct microscopic evaluation of the vaginal epithelium. Secondly, safety of the different groups will be assessed. Although previous research already indicated no increased breast cancer recurrence, there is no direct comparative data available towards the different available treatment regimes. This will be tackled in this study. Evaluation will be done be measuring sex hormone concentrations systemically, which will be a surrogate for safety evaluation.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Breast cancer patient
- Current endocrine therapy (AI or SERM)
- 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
- Presence of one or more symptoms of vulvovaginal atrophy (dyspareunia, dryness, irritation)
You likely can't join if
- 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.
- Current other vulvar or vaginal disease (e.g. dysplasia, fungal infection,…)
- Recent use of antibiotics/antifungals/corticosteroids (less than 1 month)
- Current use of vaginal hormonal treatment or vaginal moisturizer (inclusion is possible after a washout period of 4 weeks)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.