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NCT04600336CompletedPhase 2

Testing the Effects of Oxybutynin for the Treatment of Hot Flashes in Men Receiving Hormone Therapy for Prostate Cancer

A Randomized, Double-Blind, Placebo-Controlled Phase II Study of Oxybutynin Versus Placebo for the Treatment of Hot Flashes in Men Receiving Androgen Deprivation Therapy

Source: ClinicalTrials.gov · Last updated 30 Mar 2025

Brief summary (registry, in English)

This phase II trial compares the effect of oxybutynin versus placebo for reducing hot flashes in men receiving androgen deprivation (hormone) therapy for the treatment of prostate cancer . Androgen deprivation therapy decreases testosterone and other androgens through medications or surgical removal of the testicles. Relative to placebo, low- or high-dose oxybutynin may reduce hot flashes in men receiving androgen deprivation therapy.

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
88 (actual)
First submitted
19 Oct 2020
Start date
28 Oct 2021
Primary completion date
5 Feb 2024
Lead sponsor
Alliance for Clinical Trials in Oncology
NCT number
NCT04600336

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 88
  • From 28 Oct 2021 to the primary completion date, 5 Feb 2024
  • 103 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • No current use or future planned use of any of the following agents during the study period: drugs that are not Food and Drug Administration (FDA) approved for use in humans, androgens, estrogens, progesterone analogs, gabapentin, selective serotonin reuptake inhibitor (SSRI)/serotonin and norepinephrine reuptake inhibitor (SNRI) anti-depressants, cholinergic agonists, cholinesterase inhibitors, or complementary/alternative medicine taken for the purpose of managing hot flashes. Prior use of these agents is permitted as long as they are discontinued before registration
  • No current or prior use of oxybutynin
  • Patients with a history of any of the following contraindications to oxybutynin are not eligible: gastroparesis or gastrointestinal obstructive disorders; significant gastric reflux symptoms not controlled by medication; ulcerative colitis; narrow-angle glaucoma; urinary retention requiring indwelling or intermittent self-catheterization within the prior 6 months; hypersensitivity to oxybutynin or any other components of the product; current uncontrolled hyperthyroidism; uncontrolled coronary artery disease or a history of myocardial infarction within the prior 12 months; New York Heart Association (NYHA) class II-IV congestive heart failure; symptomatic cardiac arrhythmias; current uncontrolled hypertension; myasthenia gravis; or dementia

Who the study is looking for

  • Men who are currently receiving androgen deprivation therapy (ADT) for the treatment of prostate cancer. ADT is defined by a history of orchiectomy, or ongoing usage of gonadotropin-releasing hormone agonists or antagonists. Men receiving abiraterone, but not enzalutamide, apalutamide, and darolutamide are eligible, as the latter three are metabolized by CYP3A4 and may affect oxybutynin serum concentrations.
  • Patients must be on a stable dose of all hormone-directed therapies for at least 28 days prior to registration and must not be planning to discontinue this therapy for at least 42 days following registration. Patients receiving radiation therapy during the study period are eligible
  • Eligible patient must have bothersome hot flashes for \>= 14 days prior to registration, defined by an occurrence of \>= 28 times per week and of sufficient severity to cause the patient to seek therapeutic intervention
  • Life expectancy of greater than 6 months
  • Eastern Cooperative Oncology Group (ECOG) performance status - 0, 1, or 2
  • In order to complete the mandatory patient-completed measures, participants must be able to speak and/or read English

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (103)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hawaii Cancer Care - Westridge
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‘AieaUnited StatesUnknown status
McFarland Clinic - Ames
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AmesUnited StatesUnknown status
Mary Greeley Medical Center
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AmesUnited StatesUnknown status
Langlade Hospital and Cancer Center
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AntigoUnited StatesUnknown status
Ascension Saint Elizabeth Hospital
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AppletonUnited StatesUnknown status
Messino Cancer Centers
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AshevilleUnited StatesUnknown status
McFarland Clinic - Boone
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BooneUnited StatesUnknown status
Ascension Southeast Wisconsin Hospital - Elmbrook Campus
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BrookfieldUnited StatesUnknown status
Fairview Ridges Hospital
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BurnsvilleUnited StatesUnknown status
Minnesota Oncology - Burnsville
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BurnsvilleUnited StatesUnknown status
AtlantiCare Health Park-Cape May Court House
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Cape May Court HouseUnited StatesUnknown status
Ascension Calumet Hospital
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ChiltonUnited StatesUnknown status
Southeastern Medical Oncology Center-Clinton
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ClintonUnited StatesUnknown status
MU Health - University Hospital/Ellis Fischel Cancer Center
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ColumbiaUnited StatesUnknown status
Ohio State University Comprehensive Cancer Center
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ColumbusUnited StatesUnknown status
Mercy Hospital
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Coon RapidsUnited StatesUnknown status
Carle at The Riverfront
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DanvilleUnited StatesUnknown status
Cancer Care Specialists of Illinois - Decatur
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DecaturUnited StatesUnknown status
Decatur Memorial Hospital
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DecaturUnited StatesUnknown status
Medical Oncology and Hematology Associates-Des Moines
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Des MoinesUnited StatesUnknown status
Mercy Medical Center - Des Moines
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Des MoinesUnited StatesUnknown status
Iowa Methodist Medical Center
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Des MoinesUnited StatesUnknown status
Fairview Southdale Hospital
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EdinaUnited StatesUnknown status
Crossroads Cancer Center
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EffinghamUnited StatesUnknown status
Carle Physician Group-Effingham
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EffinghamUnited StatesUnknown status
AtlantiCare Surgery Center
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Egg HarborUnited StatesUnknown status
Sanford Roger Maris Cancer Center
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FargoUnited StatesUnknown status
Sanford Broadway Medical Center
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FargoUnited StatesUnknown status
Genesee Cancer and Blood Disease Treatment Center
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FlintUnited StatesUnknown status
Genesys Hurley Cancer Institute
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FlintUnited StatesUnknown status
Genesee Hematology Oncology PC
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FlintUnited StatesUnknown status
McFarland Clinic - Trinity Cancer Center
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Fort DodgeUnited StatesUnknown status
Ascension Saint Francis - Reiman Cancer Center
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FranklinUnited StatesUnknown status
Unity Hospital
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FridleyUnited StatesUnknown status
Arizona Breast Cancer Specialists-Gilbert
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GilbertUnited StatesUnknown status
Southeastern Medical Oncology Center-Goldsboro
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GoldsboroUnited StatesUnknown status
Altru Cancer Center
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Grand ForksUnited StatesUnknown status
Grand Valley Oncology
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Grand JunctionUnited StatesUnknown status
Hawaii Cancer Care Inc - Waterfront Plaza
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HonoluluUnited StatesUnknown status
University of Mississippi Medical Center
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JacksonUnited StatesUnknown status
Southeastern Medical Oncology Center-Jacksonville
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JacksonvilleUnited StatesUnknown status
Baptist MD Anderson Cancer Center
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JacksonvilleUnited StatesUnknown status
McFarland Clinic - Jefferson
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JeffersonUnited StatesUnknown status
Fairview Clinics and Surgery Center Maple Grove
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Maple GroveUnited StatesUnknown status
Minnesota Oncology Hematology PA-Maplewood
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MaplewoodUnited StatesUnknown status
Saint John's Hospital - Healtheast
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MaplewoodUnited StatesUnknown status
McFarland Clinic - Marshalltown
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MarshalltownUnited StatesUnknown status
Sovah Health Martinsville
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MartinsvilleUnited StatesUnknown status
Fremont - Rideout Cancer Center
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MarysvilleUnited StatesUnknown status
Carle Physician Group-Mattoon/Charleston
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MattoonUnited StatesUnknown status
Ascension Columbia Saint Mary's Hospital Ozaukee
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MequonUnited StatesUnknown status
Zablocki Veterans Administration Medical Center
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MilwaukeeUnited StatesUnknown status
Ascension Southeast Wisconsin Hospital - Saint Joseph Campus
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MilwaukeeUnited StatesUnknown status
Ascension Columbia Saint Mary's Hospital - Milwaukee
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MilwaukeeUnited StatesUnknown status
Abbott-Northwestern Hospital
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MinneapolisUnited StatesUnknown status
Hennepin County Medical Center
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MinneapolisUnited StatesUnknown status
Monticello Cancer Center
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MonticelloUnited StatesUnknown status
ProHealth D N Greenwald Center
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MukwonagoUnited StatesUnknown status
Cancer Center of Western Wisconsin
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New RichmondUnited StatesUnknown status
New Ulm Medical Center
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New UlmUnited StatesUnknown status
NYP/Weill Cornell Medical Center
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New YorkUnited StatesUnknown status
ProHealth Oconomowoc Memorial Hospital
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OconomowocUnited StatesUnknown status
Cancer Care Center of O'Fallon
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O'FallonUnited StatesUnknown status
Nebraska Methodist Hospital
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OmahaUnited StatesUnknown status
Nebraska Cancer Specialists/Oncology Hematology West PC - MECC
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OmahaUnited StatesUnknown status
Ascension Mercy Hospital
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OshkoshUnited StatesUnknown status
Arizona Center for Cancer Care-Peoria
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PeoriaUnited StatesUnknown status
Cancer Center at Saint Joseph's
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PhoenixUnited StatesUnknown status
Arizona Breast Cancer Specialists-Phoenix
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PhoenixUnited StatesUnknown status
Ascension All Saints Hospital
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RacineUnited StatesUnknown status
North Memorial Medical Health Center
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RobbinsdaleUnited StatesUnknown status
Mayo Clinic in Rochester
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RochesterUnited StatesUnknown status
Delbert Day Cancer Institute at PCRMC
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RollaUnited StatesUnknown status
Oncology Hematology Associates of Saginaw Valley PC
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SaginawUnited StatesUnknown status
Ascension Saint Mary's Hospital
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SaginawUnited StatesUnknown status
Park Nicollet Clinic - Saint Louis Park
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Saint Louis ParkUnited StatesUnknown status
United Hospital
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Saint PaulUnited StatesUnknown status
Regions Hospital
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Saint PaulUnited StatesUnknown status
Arizona Breast Cancer Specialists-Scottsdale
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ScottsdaleUnited StatesUnknown status
Arizona Breast Cancer Specialists
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ScottsdaleUnited StatesUnknown status
Saint Francis Regional Medical Center
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ShakopeeUnited StatesUnknown status
Sanford Cancer Center Oncology Clinic
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Sioux FallsUnited StatesUnknown status
Sanford USD Medical Center - Sioux Falls
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Sioux FallsUnited StatesUnknown status
Southern Illinois University School of Medicine
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SpringfieldUnited StatesUnknown status
Springfield Clinic
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SpringfieldUnited StatesUnknown status
Memorial Medical Center
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SpringfieldUnited StatesUnknown status
Lakeview Hospital
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StillwaterUnited StatesUnknown status
Arizona Center for Cancer Care-Surprise
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SurpriseUnited StatesUnknown status
Ascension Saint Joseph Hospital
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Tawas CityUnited StatesUnknown status
Montefiore Medical Center-Einstein Campus
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The BronxUnited StatesUnknown status
Montefiore Medical Center - Moses Campus
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The BronxUnited StatesUnknown status
Montefiore Medical Center-Weiler Hospital
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The BronxUnited StatesUnknown status
Gene Upshaw Memorial Tahoe Forest Cancer Center
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TruckeeUnited StatesUnknown status
University of Arizona Cancer Center-North Campus
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TucsonUnited StatesUnknown status
Carle Cancer Center
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UrbanaUnited StatesUnknown status
Ridgeview Medical Center
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WaconiaUnited StatesUnknown status
UW Cancer Center at ProHealth Care
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WaukeshaUnited StatesUnknown status
Aspirus Regional Cancer Center
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WausauUnited StatesUnknown status
Ascension Medical Group Southeast Wisconsin - Mayfair Road
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WauwatosaUnited StatesUnknown status
Rice Memorial Hospital
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WillmarUnited StatesUnknown status
Aspirus Cancer Care - Wisconsin Rapids
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Wisconsin RapidsUnited StatesUnknown status
Minnesota Oncology Hematology PA-Woodbury
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WoodburyUnited StatesUnknown status
Fairview Lakes Medical Center
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WyomingUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.