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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
University of Arkansas
Study ID
NCT01530373
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • solifenacin — DRUG
    oral solifenacin 5.0 mg daily for 3 weeks
  • Clonidine — DRUG
    oral clonidine 0.1 mg daily for 3 weeks

Study Details

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).

Key Dates

First listed
Feb 9, 2012
Start date
Feb 29, 2012
Status verified
Mar 2026
Primary completion
Jul 31, 2027
Completion
Sep 30, 2028

Study Design

Enrollment
110 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: solifenacin
    oral solifenacin 5.0 mg daily for 3 weeks
  • Active Comparator: clonidine
    oral clonidine 0.1 mg daily for 3 weeks

Primary Outcome Measure

Efficacy: hot flash composite and frequency scores (daily diary) [ Time Frame: from baseline to end of treatment (3 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical SciencesLittle RockArkansas722205
Allen C Sherman, PhD
[email protected]
501-686-8700
Issam Makhoul, MD (SUB_INVESTIGATOR)
Ronda Henry-Tillman, MD (SUB_INVESTIGATOR)

Find similar trials in Little Rock, AR

By condition
Breast cancerMenopause
By specialty
OncologyBreast oncologyWomen's healthFertility
By research site
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences· Little Rock, AR

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