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The RED FLASH study
EU CTIS ID: 2023-507847-13-00
What this study is testing
To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.
- Therapeutic confirmatory (Phase III)
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
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Pre-, peri- or postmenopausal women of 18 years or above; - Indication for endocrine therapy and already started with tamoxifen, aromatase inhibitors or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue for the duration of the study; - Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.
You likely can't join if
- A potential subject who meets any of the following criteria will be excluded from participation in this study: - Pregnant; - Breast feeding; - Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period; - Palliative setting; - Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year; - Creatinine clearance < 30 ml/min; - Liver cirrhosis; - Use of gabapentin and/or calcium channel antagonists within 2 weeks of study entry; - Use of oxybutynin before study entry; - Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture.
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.