MedTrace Logo

REDucing Hot FLASHes in Women Using Endocrine Therapy.

NCT06106529 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-02-04

No results posted yet for this study

Summary

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 oxybutynin versus venlafaxine.
* To assess the personal preference of women for oxybutynin versus venlafaxine in reducing hot flashes.
* To assess quality of life of women when reducing hot flashes in women using endocrine therapy after breast cancer.

Participants will fill-out a patient diary during 15 weeks total on a daily basis and receive an (online) questionnaire three times total.

Researchers will compare two groups (venlafaxine group versus oxubutynine group) to assess its efficacy concerning hot flashes.

Conditions

Interventions

DRUG

Oxybutynin

Oxybutynin 5 mg twice per day for 6 weeks

DRUG

Venlafaxine

Venlafaxine 37.5 mg once daily for 7 days followed by 75 mg once daily for 5 weeks

Sponsors & Collaborators

  • Reinier de Graaf Groep

    lead OTHER

Principal Investigators

  • Lemonitsa Mammatas, PhD · Reinier De Graaf Ziekenhuis

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-03
Primary Completion
2029-01-01
Completion
2029-01-01

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06106529 on ClinicalTrials.gov