Recruiting
Phase 2

Solifenacin vs. Clonidine

Sponsor:

University of Arkansas

Code:

NCT01530373

Conditions

Hot Flashes

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

solifenacin

Clonidine

Study Details

Brief 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).

Conditions

Hot Flashes

Breast Cancer

Study ID

NCT01530373

Start date

Feb, 2012

Status verified date

Mar, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women with a history of invasive breast cancer or DCIS
  • Currently taking aromatase inhibitors or tamoxifen
  • Not receiving hormone replacement therapy for minimum of one month
  • Age 18 years or older
  • Self-reported hot flashes at least fourteen times per week
  • Self-reported hot flashes for at least one month
  • If receiving non-tricyclic antidepressants (venlafaxine, paroxetine, citalopram, sertraline, etc.) or gabapentin, no change in regimen in past 4 weeks.

Exclusion Criteria:

  • Receiving any other treatment for hot flashes within the past month, including estrogens, progestins, androgens, or gabapentin.
  • Current use of clonidine or solifenacin. (If patients have been off of these for one month, then they are eligible)
  • History of severe renal or moderate or severe hepatic impairment, as indicated by physical exam and medical record
  • Concurrent or planned chemotherapy or radiotherapy (within next 3 months)
  • Currently receiving tricyclic antidepressants, monoamine oxidase inhibitors, barbiturates, pimozide.
  • Currently using CYP3A4 inducers (i.e., aminoglutethimide, carbamazepine, dexamethasone, efavirenz, ethosuximide, griseofulvin, modafinil, nafcillin, nevirapine, oxcarbazepine, phenobarbital, phenylbutazone, phenytoin, primidone, rifabutin, rifampin, rifapentine, St. John's Wort, sulfadimidine, sulfinpyrazone, troglitazone) or potent CYP3A4 inhibitors (i.e., chloramphenicol, clarithromycin, erythromycin, imatinib mesylate, indinavir sulfate, itraconazole, ketoconazole, nefazoldone, nelfinavir mesylate, ritonavir, telithromycin, troleandomycin).
  • Uncontrolled or poorly controlled narrow-angle glaucoma, urinary retention, gastric retention (evaluated from history \& physical exam and medical record)
  • Hypotension or uncontrolled hypertension (160/95 > BP < 100/60)
  • Severe coronary insufficiency, conduction disturbances, recent myocardial infarction (within past 3 months), cerebrovascular disease, syncope (evaluated from history \& physical and medical record)
  • History of allergy or adverse reactions to clonidine or solifenacin
  • ECOG status > 2 (in bed more than 50% of day)

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: solifenacin

oral solifenacin 5.0 mg daily for 3 weeks

active comparator: clonidine

oral clonidine 0.1 mg daily for 3 weeks

Interventions

solifenacin

oral solifenacin 5.0 mg daily for 3 weeks

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) ]
  • Safety: number of clinician-rated adverse events [ Time Frame: from consent until end of study (approximately 9 weeks) ]

Central Contacts and Locations

Central contacts

Allen C Sherman, PhD

501-686-8700shermanallenc@uams.edu

Locations

Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences

Recruiting

Little Rock, Arkansas, United States, 722205

Contacts

Allen C Sherman, PhD

501-686-8700shermanallenc@uams.edu

More Information

Sponsor

University of Arkansas

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • hot flashes
  • breast cancer
  • aromatase inhibitors
  • solifenacin
  • clonidine
  • quality of life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arkansas on 2026-03-05.