AzTrials
AzTrials

ArthralgiaPhase 3NCT01573442

Testosterone in Treating Postmenopausal Patients With Arthralgia Caused by Adjuvant Aromatase Inhibitor Treatment

A Phase 3 study testing testosterone in people with Arthralgia and Breast Cancer, run by Alliance for Clinical Trials in Oncology at 529 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Arthralgia, Breast Cancer, Hot Flashes
What is being tested?
testosterone
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
227 participants
Where
529 sitesin 2 countries
Study dates
10 Sep 2013to 1 Sep 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Age ≥ 18 years
  • Receiving anastrozole (1mg) or letrozole (2.5 mg) orally once a day, for ≥ 21 days prior to registration and plan to continue it throughout the duration of study
  • Body Mass Index (BMI) between 18 and 35 kg/m^2
  • Women who have undergone a total mastectomy or breast conserving surgery for primary breast cancer +/-chemo, +/-radiotherapy.
  • Must have BOTH ER and PR receptor-positive tumors and BOTH must be ≥26% positive. Alternatively, if ER and PR are determined by Allred score, the score needs to be 5 or higher
  • Women who are postmenopausal by surgery, radiotherapy or presence of natural amenorrhea ≥ 12 months
Show all 18Show fewer
  • ≥ 5/10 arthralgia (in hands, wrist, knees, or hips) while being treated with anastrozole or letrozole which is felt by the patient to be caused by their aromatase inhibitor as defined in the protocol. Note: Patients may, or may not, be taking non-opioid analgesics
  • Ability to complete questionnaire(s) by themselves or with assistance
  • ECOG Performance Status (PS) 0, 1 or 2
  • Willing to provide informed written consent
  • Willing to return to an Alliance enrolling institution for follow-up
  • Willing to provide blood samples for correlative research purposes
  • Laboratory values prior to registration as defined in the protocol:
  • Creatinine ≤1.5 x ULN
  • Hemoglobin > 11 g/dL
  • WBC > 3.0
  • Platelet Count > 100,000
  • SGOT (AST) ≤ 1.5 x ULN

Who cannot join

  • Presence of residual or recurrent cancer (locally or metastatic)
  • Diabetes mellitus or glucose intolerance, defined as a fasting glucose >125 mg/dL
  • History of coronary artery disease (angina or myocardial infarction)
  • Patients on hormone replacement therapy (HRT) ≤ 4 weeks prior to registration. This includes the use of vaginal estrogen therapy.
  • Known hypersensitivity to any component of testosterone.
  • Prolonged systemic corticosteroid treatment, except for topical applications (e.g. for rash), inhaled sprays (e.g. for obstructive airway diseases), eye drops or local insertion (e.g. intra-articular). Note: Short duration (< 2 weeks) of systemic corticosteroids is allowed (e.g. for chronic obstructive pulmonary disease) but not within 30 days prior to registration.
Show all 11Show fewer
  • Receiving any other investigational agent
  • History of a deep venous thrombosis or a thromboembolism
  • Concurrent use of the aromatase inhibitor exemestane, as it is structurally similar to an androgen
  • Concurrent radiation therapy or chemotherapy
  • Current or planned use of cyclosporine, anticoagulants, oxphenbutazone, insulin, oral or injectable vitamin D doses over 4,000IU/day, or tamoxifen

Trial locations and contacts

529 sites in 2 countries.

301 sites in 2 countries

United States300 sites

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Bixby Medical Center

    Adrian, Michigan, 49221

  • Hickman Cancer Center

    Adrian, Michigan, 49221

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC-William R Bliss Cancer Center

    Ames, Iowa, 50010

  • Community Hospital of Anaconda

    Anaconda, Montana, 59711

  • Cancer Care Center at Island Hospital

    Anacortes, Washington, 98221

  • Anchorage Associates in Radiation Medicine

    Anchorage, Alaska, 98508

  • Anchorage Radiation Therapy Center

    Anchorage, Alaska, 99504

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Oncology and Hematology LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • ThedaCare Regional Cancer Center

    Appleton, Wisconsin, 54911

  • University Cancer and Blood Center LLC

    Athens, Georgia, 30607

  • Northside Hospital

    Atlanta, Georgia, 30342

  • Sutter Auburn Faith Hospital

    Auburn, California, 95602

  • Sutter Cancer Centers Radiation Oncology Services-Auburn

    Auburn, California, 95603

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • The Medical Center of Aurora

    Aurora, Colorado, 80012

  • Rush - Copley Medical Center

    Aurora, Illinois, 60504

  • Saint Louis Cancer and Breast Institute-Ballwin

    Ballwin, Missouri, 63011

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Ochsner Health Center-Summa

    Baton Rouge, Louisiana, 70809

  • Franciscan Saint Francis Health-Beech Grove

    Beech Grove, Indiana, 46107

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Gaston Hematology and Oncology Associates-Belmont

    Belmont, North Carolina, 28012

  • Sanford Clinic North-Bemidgi

    Bemidji, Minnesota, 56601

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Constantinou, Costas L MD (UIA Investigator)

    Bettendorf, Iowa, 52722

  • University of Iowa Healthcare Cancer Services Quad Cities

    Bettendorf, Iowa, 52722

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Saint Vincent Healthcare

    Billings, Montana, 59101

  • Montana Cancer Consortium NCORP

    Billings, Montana, 59102

  • Saint Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Saint Joseph Medical Center

    Bloomington, Illinois, 61701

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Saint Luke's Mountain States Tumor Institute

    Boise, Idaho, 83712

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Parkland Health Center-Bonne Terre

    Bonne Terre, Missouri, 63628

  • McFarland Clinic PC-Boone

    Boone, Iowa, 50036

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Toledo Clinic Cancer Centers-Bowling Green

    Bowling Green, Ohio, 43402

  • Bozeman Deaconess Hospital

    Bozeman, Montana, 59715

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Harrison Medical Center

    Bremerton, Washington, 98310

  • Wellmont Bristol Regional Medical Center

    Bristol, Tennessee, 37620

  • Wellmont Medical Associates Oncology and Hematology-Bristol

    Bristol, Tennessee, 37620

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Saint James Community Hospital and Cancer Treatment Center

    Butte, Montana, 59701

  • Cooper Hospital University Medical Center

    Camden, New Jersey, 08103

  • Sutter Cancer Centers Radiation Oncology Services-Cameron Park

    Cameron Park, California, 95682

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • Southeast Cancer Center

    Cape Girardeau, Missouri, 63703

  • Memorial Hospital of Carbondale

    Carbondale, Illinois, 62902

  • SIH Cancer Institute

    Carterville, Illinois, 62918

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Rocky Mountain Oncology

    Casper, Wyoming, 82609

  • Eden Hospital Medical Center

    Castro Valley, California, 94546

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Roper Hospital

    Charleston, South Carolina, 29401

  • Charleston Hematology Oncology Associates-Roper

    Charleston, South Carolina, 29403

  • Lowcountry Hematology Oncology PA-North Charleston

    Charleston, South Carolina, 29406

  • Bon Secours Saint Francis Hospital

    Charleston, South Carolina, 29414

  • Charleston Hematology Oncology Associates PA-Saint Francis

    Charleston, South Carolina, 29414

  • Lowcountry Hematology Oncology PA-West Ashley

    Charleston, South Carolina, 29414

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Carolina Surgical Clinic of Charlotte PA

    Charlotte, North Carolina, 28207

  • Oncology Specialists of Charlotte

    Charlotte, North Carolina, 28207

  • Southern Oncology Specialists-Charlotte

    Charlotte, North Carolina, 28262

  • Memorial Hospital

    Chattanooga, Tennessee, 37404

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • Weiss Memorial Hospital

    Chicago, Illinois, 60640

  • Oncology Hematology Care Inc-Eden Park

    Cincinnati, Ohio, 45202

  • Oncology Hematology Care Inc-Mercy West

    Cincinnati, Ohio, 45211

  • University of Cincinnati/Barrett Cancer Center

    Cincinnati, Ohio, 45219

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Oncology Hematology Care Inc - Anderson

    Cincinnati, Ohio, 45230

  • Oncology Hematology Care Inc-Kenwood

    Cincinnati, Ohio, 45236

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • Oncology Hematology Care Inc-Blue Ash

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Providence Oncology and Hematology Care Southeast

    Clackamas, Oregon, 97015

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Big Horn Basin Cancer Center

    Cody, Wyoming, 82414

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Bay Area Hospital

    Coos Bay, Oregon, 97420

  • Commonwealth Cancer Center-Corbin

    Corbin, Kentucky, 40701

  • Alegent Health Mercy Hospital

    Council Bluffs, Iowa, 51503

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Oncology Hematology Care Inc-Crestview

    Crestview Hills, Kentucky, 41017

  • Mass General/North Shore Cancer Center

    Danvers, Massachusetts, 01923

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Sutter Davis Hospital

    Davis, California, 95616

  • Grandview Hospital

    Dayton, Ohio, 45405

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physicians LLC-Samaritan North

    Dayton, Ohio, 45415

  • Samaritan North Health Center

    Dayton, Ohio, 45415

  • Dayton NCI Community Oncology Research Program

    Dayton, Ohio, 45420

  • Dekalb Medical Center

    Decatur, Georgia, 30033

  • Cancer Care Specialists of Central Illinois

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Colorado Blood Cancer Institute

    Denver, Colorado, 80218

  • Presbyterian - Saint Lukes Medical Center - Health One

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • SCL Health Saint Joseph Hospital

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Rose Medical Center

    Denver, Colorado, 80220

  • Colorado Cancer Research Program NCORP

    Denver, Colorado, 80222

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Epic Care-Dublin

    Dublin, California, 94568

  • Mercy Medical Center

    Durango, Colorado, 81301

  • Southwest Oncology PC

    Durango, Colorado, 81301

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Marshfield Clinic Cancer Center - Eau Claire

    Eau Claire, Wisconsin, 54701

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Saint Elizabeth Medical Center South

    Edgewood, Kentucky, 41017

  • Swedish Medical Center-Edmonds

    Edmonds, Washington, 98026

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Hematology Oncology Center Incorporated

    Elyria, Ohio, 44035

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Bay Area Breast Surgeons Inc

    Emeryville, California, 94608

  • Epic Care Partners in Cancer Care

    Emeryville, California, 94608

  • Comprehensive Cancer Care and Research Institute of Colorado LLC

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • Englewood Hospital and Medical Center

    Englewood, New Jersey, 07631

  • Saint Elizabeth Hospital

    Enumclaw, Washington, 98022

  • Green Bay Oncology - Escanaba

    Escanaba, Michigan, 49829

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • IMG Hematology Oncology 8501

    Fairfax, Virginia, 22031

  • Inova Fair Oaks Hospital

    Fairfax, Virginia, 22033

  • Oncology Hematology Care Inc-Healthplex

    Fairfield, Ohio, 45014

  • Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Clinic North-Fargo

    Fargo, North Dakota, 58122

  • Saint Francis Hospital

    Federal Way, Washington, 98003

  • Armes Family Cancer Center

    Findlay, Ohio, 45840

  • Blanchard Valley Hospital

    Findlay, Ohio, 45840

  • Orion Cancer Care

    Findlay, Ohio, 45840

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • McFarland Clinic PC-Trinity Cancer Center

    Fort Dodge, Iowa, 50501

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Saint Elizabeth Fort Thomas

    Fort Thomas, Kentucky, 41075

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Fredericksburg Oncology Inc

    Fredericksburg, Virginia, 22401

  • Palo Alto Medical Foundation-Fremont

    Fremont, California, 94538

  • Washington Hospital

    Fremont, California, 94538

  • Saint Luke's Mountain States Tumor Institute - Fruitland

    Fruitland, Idaho, 83619

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Western Illinois Cancer Treatment Center

    Galesburg, Illinois, 61401

  • CaroMont Regional Medical Center

    Gastonia, North Carolina, 28054

  • Gaston Hematology and Oncology Associates

    Gastonia, North Carolina, 28054

  • Northwestern Medicine Cancer Center Delnor

    Geneva, Illinois, 60134

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • Glens Falls Hospital

    Glens Falls, New York, 12801

  • Mountain Blue Cancer Care Center

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Great Falls Clinic

    Great Falls, Montana, 59405

  • North Colorado Medical Center

    Greeley, Colorado, 80631

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Rocky Mountain Cancer Centers-Greenwood Village

    Greenwood Village, Colorado, 80111

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Ingalls Memorial Hospital

    Harvey, Illinois, 60426

  • Saint Peter's Community Hospital

    Helena, Montana, 59601

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • 21st Century Oncology-Henderson

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • Pulmonary Medicine Center of Chattanooga-Hixson

    Hixson, Tennessee, 37343

  • New Hampshire Oncology Hematology PA-Hooksett

    Hooksett, New Hampshire, 03106

  • CHI Saint Vincent Cancer Center Hot Springs

    Hot Springs, Arkansas, 71913

  • Lake Norman Hematology Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

  • Southern Oncology Specialists-Huntersville

    Huntersville, North Carolina, 28078

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • Franciscan Health Indianapolis

    Indianapolis, Indiana, 46237

  • Green Bay Oncology - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Swedish Cancer Institute-Issaquah

    Issaquah, Washington, 98029

  • Jackson-Madison County General Hospital

    Jackson, Tennessee, 38301

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • McFarland Clinic PC-Jefferson

    Jefferson, Iowa, 50129

  • Capital Region Medical Center-Goldschmidt Cancer Center

    Jefferson City, Missouri, 65109

  • Wellmont Medical Associates Oncology and Hematology-Johnson City

    Johnson City, Tennessee, 37604

  • Freeman Health System

    Joplin, Missouri, 64804

  • Mercy Hospital Joplin

    Joplin, Missouri, 64804

  • Kalispell Medical Oncology

    Kalispell, Montana, 59901

  • Kalispell Regional Medical Center

    Kalispell, Montana, 59901

  • Heartland Hematology and Oncology

    Kearney, Nebraska, 68845

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Kadlec Clinic Hematology and Oncology

    Kennewick, Washington, 99336

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Wellmont Holston Valley Hospital and Medical Center

    Kingsport, Tennessee, 37660

  • Wellmont Medical Associates Oncology and Hematology-Kingsport

    Kingsport, Tennessee, 37660

  • Kinston Medical Specialists PA

    Kinston, North Carolina, 28501

  • University of Tennessee - Knoxville

    Knoxville, Tennessee, 37920

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Mayo Clinic Health System-Franciscan Healthcare

    La Crosse, Wisconsin, 54601

  • AMITA Health Adventist Medical Center

    La Grange, Illinois, 60525

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • LRGHealthcare-Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

  • Rocky Mountain Cancer Centers-Lakewood

    Lakewood, Colorado, 80228

  • Saint Anthony Hospital

    Lakewood, Colorado, 80228

  • Saint Clare Hospital

    Lakewood, Washington, 98499

  • Doctor's Hospital of Laredo

    Laredo, Texas, 78041

  • University Medical Center of Southern Nevada

    Las Vegas, Nevada, 89102

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • Nevada Cancer Research Foundation CCOP

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • 21st Century Oncology

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

  • 21st Century Oncology-Vegas Tenaya

    Las Vegas, Nevada, 89128

  • Cancer and Blood Specialists-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • 21st Century Oncology-Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • Nevada Cancer Specialists-Fort Apache

    Las Vegas, Nevada, 89148

  • HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

    Las Vegas, Nevada, 89149

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Saint Mary's Regional Medical Center

    Lewiston, Maine, 04240

  • Saint Joseph Radiation Oncology Resource Center

    Lexington, Kentucky, 40504

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Lima Memorial Hospital

    Lima, Ohio, 45804

  • Saint Elizabeth Regional Medical Center

    Lincoln, Nebraska, 68510

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Littleton Adventist Hospital

    Littleton, Colorado, 80122

  • The Dana-Farber Cancer Institute at Londonderry

    Londonderry, New Hampshire, 03053

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

Other trials in United States

Puerto Rico1 site

  • San Juan City Hospital

    San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: Randomized Double-Blind Placebo Controlled Study of Testosterone in the Adjuvant Treatment of Postmenopausal Women With Aromatase Inhibitor Induced Arthralgias

This randomized phase III trial studies testosterone to see how well it works compared to placebo in treating postmenopausal patients with arthralgia (joint pain) caused by anastrozole or letrozole. Testosterone may help relieve moderate or severe arthralgia associated with the use of aromatase inhibitors, such as anastrozole or letrozole.

Read the detailed description

This is a randomized, placebo-controlled, phase III trial evaluating subcutaneous testosterone for the alleviation of aromatase inhibitor induced arthralgia. A parallel group design will be utilized for this two-arm study: subcutaneous testosterone vs. placebo. Patients are stratified according to baseline pain score (5-6 vs. 7-10) and age (< 50 vs. 50-60 vs. > 60). The primary objective is to determine whether testosterone will reduce AI-induced arthralgia and associated joint symptoms. The secondary objective is to explore whether testosterone will have an acceptable safety and tolerability profile, with particular reference to androgenic adverse events including acne, hirsutism, and alopecia.

Patients are followed up to six months as defined in the protocol.

Being tested
testosterone, placebo
Keywords
hot flashes, musculoskeletal complications, sexual dysfunction, estrogen receptor-positive breast cancer, progesterone receptor-positive breast cancer, arthralgia, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Medical subject headings
Arthralgia, Breast Neoplasms, Hot Flashes, Sexual Dysfunction, Physiological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • testosteroneDrug

    10.4 mg

  • placeboOther

Study groups in NCT01573442
Study groupRoleWhat they receive
Arm IExperimentalPatients receive testosterone (0.264mL) topical application daily for six months.
Receives: Drug: testosterone
Arm IIPlacebo comparatorPatients receive placebo (0.264mL) topical application daily for six months.
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3

    The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and month 3 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: From baseline to 3 months

  2. Improvement in BPI Average Pain From Baseline to Month 3

    "2. Was there an improvement in BPI Average Pain from baseline to month 3?"

    Measured: Up to 3 months

  3. Change in BPI Average Change From Baseline Pain Score to Month Six Average Pain Score

    Change in BPI Average Change from Baseline Pain Score to Month Six Average Pain Score. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: Baseline and 6 months

  4. Change in BPI Average Pain From Baseline to Month 1-6

    Change in BPI Average Pain from baseline to month 1-6. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: Baseline and months 1-6

Secondary outcomes (12)

  1. Number of Participants With Grade 3 Or Higher Adverse Events Considered At Least Possibly Related to Treatment

    The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below.

    Measured: Up to 6 months

  2. Number of Patients Who Reported Alopecia Using CTCAE 4.0

    The number of patients who reported alopecia using CTCAE 4.0 is reported below for each arm.

    Measured: Up to 6 months

  3. Number of Patients Who Reported Acne Using CTCAE 4.0

    The number of patients who reported acne using CTCAE 4.0 is reported below for each arm.

    Measured: Up to 6 months

  4. Number of Patients Who Reported Hirsutism Using CTCAE 4.0

    The number of patients who reported hirsutism using CTCAE 4.0 is reported below for each arm by grade.

    Measured: Up to 6 months

  5. Change in Hot Flash Frequency From Baseline to Week 8

    Change in hot flash frequency from baseline to week 8. Hot flash frequency is a count of the number of hot flashes per day and is a number from 0 to infinity. Higher values are worse.

    Measured: baseline and week 8

  6. The Change of Libido From Baseline to Month 3 as Measured by the MENQOL

    Change in how bothered are you by decreased sex drive from baseline to month 3. This is assessed using one question off of the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks "How bothered are you by a decrease in your sexual drive". This is collected on a scale ranging from 0=Not at all bothered to 6=Extremely bothered, with higher values being worse.

    Measured: baseline and month 3

  7. The Change of Menopause Specific Quality of Life From Baseline to Month 3 as Measured by MENQOL "How Bothered Are You by Hot Flashes"

    The change of menopause specific quality of life from baseline to month 3 as measured by MENQOL "how bothered are you by Hot Flashes". This is one question from the MENQOL (Menopause-Specific Quality of Life) questionnaire. The question asks "How bothered are you by hot flashes or flushes". This is collected on a scale ranging from 0=Not at all bothered t 6=Extremely bothered, with higher values being worse.

    Measured: baseline and month 3

  8. Change in BPI Worst Pain From Baseline to Month 3

    Change in BPI Worst Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: baseline and month 3

  9. Change in BPI Least Pain From Baseline to Month 3

    Change in BPI Least Pain from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: baseline and month 3

  10. Change in BPI Pain Right Now From Baseline to Month 3

    Change in BPI Pain right now from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: baseline and month 3

  11. Change in Average Joint Stiffness From Baseline to Month 3 as Measured by BPI Item #5 (Joint Stiffness)

    Change in average joint stiffness from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: baseline and month 3

  12. The Intrapatient Change in Activity Level (Interference of Activity) for Each Month From Baseline as Measured by Item#6 (Interference) of the BPI-AIA.

    The intrapatient change in activity level (interference of activity) for each month from baseline as measured by item#6 (interference) of the BPI-AIA. Change in general activity from baseline to month 3. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Measured: baseline and month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Apr 2012 (estimated)
  2. Study start10 Sep 2013
  3. Primary completion28 Feb 2018
  4. Study completion1 Sep 2019

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01573442
Sponsor's protocol ID
A221102
Other IDs
CDR0000730083, NCI-2012-00719, U10CA037447, UG1CA189823
Status last verified
Jan 2025
First submitted
6 Apr 2012
Last updated
28 Jan 2025
Data monitoring committee
Yes

Publications

  • Cathcart-Rake E, Novotny P, Leon-Ferre R, Le-Rademacher J, Storrick EM, Adjei AA, Terstriep S, Glaser R, Giuliano A, Mitchell WR, Page S, Austin C, Deming RL, Ferreira MA, Lafky JM, Birrell SN, Loprinzi CL. A randomized, double-blind, placebo-controlled trial of testosterone for treatment of postmenopausal women with aromatase inhibitor-induced arthralgias: Alliance study A221102. Support Care Cancer. 2021 Jan;29(1):387-396. doi: 10.1007/s00520-020-05473-2. Epub 2020 May 6.

    PubMed 32372176

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing testosterone in people with Arthralgia and Breast Cancer, run by Alliance for Clinical Trials in Oncology at 529 sites in 2 countries.

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 18 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: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 529 sites in United States, Puerto Rico. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Item #3 (Average) of the Brief Pain Inventory (BPI) Average Pain From Baseline to Month 3 (time frame: From baseline to 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01573442, which also lists 1 linked publication.

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 28 Jan 2025.

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