NCT01530373

Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients

A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: University of Arkansas · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Hot flashes present a considerable problem for many breast cancer patients; these symptoms may be intensified by hormonal therapies, such as aromatase inhibitors or tamoxifen. This study examines the value of solifenacin (a muscarinic acetylcholine receptor antagonist) in reducing hot flashes, compared with clonidine (a medication often used for treating hot flashes).

Detailed description

There has been considerable interest in developing new treatment strategies for managing hot flashes among women with breast cancer, in view of the limitations associated with currently available treatments. This randomized study evaluates the safety and efficacy of 3 weeks of solifenacin compared to 3 weeks of clonidine, for women receiving adjuvant hormonal therapy (aromatase inhibitors or tamoxifen) for breast cancer.

Conditions

• Hot Flashes
• Breast Cancer

Interventions

Type	Name	Description
DRUG	solifenacin	oral solifenacin 5.0 mg daily for 3 weeks
DRUG	Clonidine	oral clonidine 0.1 mg daily for 3 weeks

Timeline

• Start date: 2012-02-01
• Primary completion: 2027-07-01
• Completion: 2028-09-01
• First posted: 2012-02-09
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States