REDucing Hot FLASHes in Women Using Endocrine Therapy.
Recruiting
Phase 3
Interventional Study
Breast Cancer
Hot Flash Due to Medication
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 260 (estimated)
- Sponsor
- Reinier de Graaf Groep · Other
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About This Trial
The goal of this randomized intrapatient cross-over study is to assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.
The objectives it aims to answer are:
* To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer
* To assess side effects of ox…
Trial Locations
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Eligibility Criteria
Inclusion 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;…
Contacts