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RECRUITING
NCT06106529
PHASE3

REDucing Hot FLASHes in Women Using Endocrine Therapy.

Sponsor: Reinier de Graaf Groep

View on ClinicalTrials.gov

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.

Official title: A Randomized Intrapatient Cross-over Study to Assess the Efficacy of Oxybutynin Versus Venlafaxine in Reducing Hot Flashes in Women Using Endocrine Therapy After Breast Cancer.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

260

Start Date

2024-10-03

Completion Date

2029-01-01

Last Updated

2025-02-04

Healthy Volunteers

No

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

Locations (1)

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands