Hot FlashesPhase 2NCT01530373
Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients
A Phase 2 study testing solifenacin and Clonidine in people with Hot Flashes and Breast Cancer, run by University of Arkansas at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hot Flashes, Breast Cancer
- What is being tested?
- solifenacin and Clonidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Winthrop P. Rockefeller Cancer Institute, University of Arkansas for Medical Sciences
Little Rock, Arkansas, 722205
Allen C Sherman, PhD, 501-686-8700, shermanallenc@uams.edu
Issam Makhoul, MD
About this study
Official title: A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
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).
Read the 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
- Being tested
- solifenacin, Clonidine
- Keywords
- hot flashes, breast cancer, aromatase inhibitors, solifenacin, clonidine, quality of life
- Medical subject headings
- Hot Flashes, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
solifenacinDrug
Also called Vesicare
oral solifenacin 5.0 mg daily for 3 weeks
ClonidineDrug
Also called Catapres, Dixarit
oral clonidine 0.1 mg daily for 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| solifenacin | Experimental | oral solifenacin 5.0 mg daily for 3 weeks Receives: Drug: solifenacin |
| clonidine | Active comparator | oral clonidine 0.1 mg daily for 3 weeks Receives: Drug: Clonidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: hot flash composite and frequency scores (daily diary)
to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Measured: from baseline to end of treatment (3 weeks)
Safety: number of clinician-rated adverse events
to evaluate changes in number of adverse events for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Measured: from consent until end of study (approximately 9 weeks)
Secondary outcomes (3)
daily functioning (Hot Flash-Related Daily Interference score)
to evaluate changes in daily functioning (Hot Flash-Related Daily Interference Score) for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Measured: from baseline to end of treatment (3 weeks)
sleep (Insomnia Severity Index)
To evaluate changes in sleep
Measured: from baseline to end of treatment (3 weeks)
quality of life (Illness Cognition Questionnaire, SF-12)
to evaluate changes in health-related quality of life. (Additional analyses will be observational, exploring associations between quality of life and meaning-making.)
Measured: from baseline to end of treatment (3 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionJul 2027 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hot FlashesStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Allen C Sherman, PhD, Principal investigator, Universitiy of Arkansas for Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530373
- Sponsor's protocol ID
- 132500
- Status last verified
- Mar 2026
- First submitted
- 7 Feb 2012
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Study of Solifenacin Compared to Clonidine for Reducing Hot Flashes Among Breast Cancer Patients Receiving Adjuvant Hormonal Therapy
- ClinicalTrials.gov ID
- NCT01530373
- Acronym / sponsor ID
- 132500
- Conditions
- Hot Flashes, Breast Cancer
- Keywords
- hot flashes, breast cancer, aromatase inhibitors, solifenacin, clonidine, quality of life
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 9 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| solifenacin | Experimental | Drug: solifenacinoral solifenacin 5.0 mg daily for 3 weeks |
| clonidine | Active comparator | Drug: Clonidineoral clonidine 0.1 mg daily for 3 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| solifenacinAlso: Vesicareoral solifenacin 5.0 mg daily for 3 weeks | Drug | solifenacin |
| ClonidineAlso: Catapres, Dixaritoral clonidine 0.1 mg daily for 3 weeks | Drug | clonidine |
Primary outcome
Efficacy: hot flash composite and frequency scores (daily diary)
Time frame: from baseline to end of treatment (3 weeks)
to evaluate changes in hot flash composite and frequency scores for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
Safety: number of clinician-rated adverse events
Time frame: from consent until end of study (approximately 9 weeks)
to evaluate changes in number of adverse events for women receiving 3 weeks of oral solifenacin compared to those receiving 3 weeks of oral clonidine
3 secondary outcomes
daily functioning (Hot Flash-Related Daily Interference score)
Time frame: from baseline to end of treatment (3 weeks)
sleep (Insomnia Severity Index)
Time frame: from baseline to end of treatment (3 weeks)
quality of life (Illness Cognition Questionnaire, SF-12)
Time frame: from baseline to end of treatment (3 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Allen C Sherman, PhD principal investigator
Universitiy of Arkansas for Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing solifenacin and Clonidine in people with Hot Flashes and Breast Cancer, run by University of Arkansas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Allen C Sherman, PhD (501-686-8700, shermanallenc@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy: hot flash composite and frequency scores (daily diary) (time frame: from baseline to end of treatment (3 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.