AzTrials
AzTrials

Breast CarcinomaPhase 2NCT03180294

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

A Phase 2 study testing Bupropion 150 mg XL in people with Breast Carcinoma and Cervical Carcinoma, run by NRG Oncology at 362 sites in United States.

Completed

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

Official record

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Trial summary

This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Bupropion 150 mg XL
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
230 participants
Where
362 sitesUnited States
Study dates
31 May 2017to 22 Feb 2021
Phase
Phase 2

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

  • PRIOR TO STEP 1 REGISTRATION
  • Score of < 9 on the PHQ-4
  • Patients must have a FSFI desire subscale baseline score less than 3.3
  • NOTE-Both the PHQ-4 and FSFI must be completed by the patient and data entered in Oncology Patient Enrollment Network (OPEN) at Step 1 registration to determine eligibility
  • Diagnosis of breast or gynecologic cancer [examples are lobular carcinoma in situ (LCIS),ductal carcinoma in situ (DCIS), invasive breast, ovarian, endometrial, vulvar, cervical and vaginal]
  • Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
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  • Post menopausal as defined by at least ONE of the following:
  • 12 months (365 days) without a period;
  • Bilateral oophorectomy;
  • Chemically induced menopause as long as there are no plans to stop during the study;
  • For women 57 and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (> 30 mIU/mL) and estradiol in menopausal range per institution?s laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise);
  • At least one ovary intact and 180 days without a period with FSH (> 30 mIU/mL) and estradiol in menopausal range per institution's laboratory (< 10 for ultra sensitive assay: < 25-30 otherwise); Note: Women 58 and older do not have to have hormonal tests.
  • History, physical and performance status of 2 or less within 180 days prior to registration
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2.5 x upper limit of normal (ULN)
  • Total bilirubin =< 1.5 x ULN
  • Glomerular filtration rate > 90ml/min
  • For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but not current tamoxifen. Prior tamoxifen is permitted with a 30 day wash out period). )
  • Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring (< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study
  • Antidepressants for mood and hot flashes, including selective serotonin reuptake inhibitors (SSRIs) will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study; only subthreshold or low dose antidepressants will be allowed (e.g. Effexor up to 75 mg or Lexapro 5-10 mg or Celexa 10- 20 mg)
  • The patient must provide study-specific informed consent prior to study entry/screening
  • Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis
  • Able to swallow whole capsules
  • Proficient in English (due to number of questionnaires not validated in other languages)
  • Completion of the FSFI and PHQ-4; both questionnaires will be required and data entered at the time of step 1 registration
  • PRIOR TO STEP 2 RANDOMIZATION
  • Completion of the following baseline quality of life forms: PHQ-4, FSFI, PROMIS sexual function and satisfaction, PROMIS fatigue short form 8a, Impact of Treatment Scale, patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items, and revised dyadic adjustment scale; these quality of life forms will be required and data must be entered in Medidata Rave at step 2 registration; if available at the time of step 1 registration, step 2 registration can take place immediately after step 1; women who do not currently have a partner do not have to complete the revised dyadic adjustment scale; enter "no partner" for this form

Who cannot join

  • Untreated depression, major depressive disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on Diagnostic and Statistical Manual (DSM) IV diagnoses
  • Seizure disorders
  • Current or history of anorexia or bulimia in the past 5 years
  • Allergy to bupropion
  • Use of drugs metabolized by CYP2D6
  • Stage IV cancer
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  • History of Parkinson's disease, multiple sclerosis or fibromyalgia
  • Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris
  • Women who are currently undergoing or planning to undergo reconstruction surgery during the course of the study; women who have completed reconstruction surgery must be 30 days from surgery
  • Oral or transdermal estrogen therapy is not allowed
  • Males are not permitted to participate
  • Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use
  • Patients who discontinue monoamine oxidase (MAO)-inhibitor (I)'s within 14 days prior to starting the investigational drug
  • Poorly controlled hypertension (systolic blood pressure [BP] >= 160 mmHg or diastolic BP >= 100 mmHg) on three or more readings in the past 12 months
  • Patients with active bipolar disorder
  • Patients with impaired decision making as determined by the treating physician
  • Concurrent use of bupropion
  • Concomitant invasive malignancy requiring treatment other than non-melanomatous skin cancer.
  • Previous or concurrent use of flibanserin.

Trial locations and contacts

362 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • University of New Mexico Cancer Center

    Albuquerque, New Mexico, 87106

  • American Fork Hospital / Huntsman Intermountain Cancer Center

    American Fork, Utah, 84003

  • Kaiser Permanente-Anaheim

    Anaheim, California, 92806

  • Trinity Health Saint Joseph Mercy Hospital Ann Arbor

    Ann Arbor, Michigan, 48106

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531

  • Randolph Hospital

    Asheboro, North Carolina, 27203

  • Duluth Clinic Ashland

    Ashland, Wisconsin, 54806

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Rocky Mountain Cancer Centers-Aurora

    Aurora, Colorado, 80012

  • Kaiser Permanente-Baldwin Park

    Baldwin Park, California, 91706

  • Mercy Oncology and Hematology - Clayton-Clarkson

    Ballwin, Missouri, 63011

  • Flaget Memorial Hospital

    Bardstown, Kentucky, 40004

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Northwell Health Imbert Cancer Center

    Bay Shore, New York, 11706

  • Indu and Raj Soin Medical Center

    Beavercreek, Ohio, 45431

  • Kaiser Permanente-Bellflower

    Bellflower, California, 90706

  • Strecker Cancer Center-Belpre

    Belpre, Ohio, 45714

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Sanford Bismarck Medical Center

    Bismarck, North Dakota, 58501

  • Prisma Health Cancer Institute - Spartanburg

    Boiling Springs, South Carolina, 29316

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Rocky Mountain Cancer Centers-Boulder

    Boulder, Colorado, 80304

  • Bozeman Health Deaconess Hospital

    Bozeman, Montana, 59715

  • Essentia Health Saint Joseph's Medical Center

    Brainerd, Minnesota, 56401

  • Trinity Health IHA Medical Group Hematology Oncology - Brighton

    Brighton, Michigan, 48114

  • Trinity Health Medical Center - Brighton

    Brighton, Michigan, 48114

  • Saint Joseph Regional Cancer Center

    Bryan, Texas, 77802

  • Bryn Mawr Hospital

    Bryn Mawr, Pennsylvania, 19010

  • Cone Health Cancer Center at Alamance Regional

    Burlington, North Carolina, 27215

  • Aurora Cancer Care-Southern Lakes VLCC

    Burlington, Wisconsin, 53105

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Saint Alphonsus Cancer Care Center-Caldwell

    Caldwell, Idaho, 83605

  • Trinity Health IHA Medical Group Hematology Oncology - Canton

    Canton, Michigan, 48188

  • Trinity Health Medical Center - Canton

    Canton, Michigan, 48188

  • Saint Francis Medical Center

    Cape Girardeau, Missouri, 63703

  • AtlantiCare Health Park-Cape May Court House

    Cape May Court House, New Jersey, 08210

  • Physicians' Clinic of Iowa PC

    Cedar Rapids, Iowa, 52402

  • Dayton Physicians LLC-Miami Valley South

    Centerville, Ohio, 45459

  • Miami Valley Hospital South

    Centerville, Ohio, 45459

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Chelsea Hospital

    Chelsea, Michigan, 48118

  • Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

    Chelsea, Michigan, 48118

  • Cheyenne Regional Medical Center-West

    Cheyenne, Wyoming, 82001

  • John H Stroger Jr Hospital of Cook County

    Chicago, Illinois, 60612

  • Adena Regional Medical Center

    Chillicothe, Ohio, 45601

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Good Samaritan Hospital - Cincinnati

    Cincinnati, Ohio, 45220

  • Bethesda North Hospital

    Cincinnati, Ohio, 45242

  • TriHealth Cancer Institute-Westside

    Cincinnati, Ohio, 45247

  • TriHealth Cancer Institute-Anderson

    Cincinnati, Ohio, 45255

  • Hematology Oncology Consultants-Clarkston

    Clarkston, Michigan, 48346

  • Newland Medical Associates-Clarkston

    Clarkston, Michigan, 48346

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Prisma Health Cancer Institute - Laurens

    Clinton, South Carolina, 29325

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Columbus Oncology and Hematology Associates Inc

    Columbus, Ohio, 43214

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Grant Medical Center

    Columbus, Ohio, 43215

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43219

  • Doctors Hospital

    Columbus, Ohio, 43228

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Carle at The Riverfront

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Good Samaritan Hospital - Dayton

    Dayton, Ohio, 45406

  • Miami Valley Hospital

    Dayton, Ohio, 45409

  • Dayton Physician LLC - Englewood

    Dayton, Ohio, 45415

  • Miami Valley Hospital North

    Dayton, Ohio, 45415

  • Dayton Veterans Affairs Medical Center

    Dayton, Ohio, 45428

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Essentia Health - Deer River Clinic

    Deer River, Minnesota, 56636

  • Delaware Health Center-Grady Cancer Center

    Delaware, Ohio, 43015

  • Denver Health Medical Center

    Denver, Colorado, 80204

  • Kaiser Permanente-Franklin

    Denver, Colorado, 80205

  • National Jewish Health-Main Campus

    Denver, Colorado, 80206

  • The Women's Imaging Center

    Denver, Colorado, 80209

  • Rocky Mountain Cancer Centers-Midtown

    Denver, Colorado, 80218

  • Saint Joseph Hospital - Cancer Centers of Colorado

    Denver, Colorado, 80218

  • Rocky Mountain Cancer Centers-Rose

    Denver, Colorado, 80220

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • UI Health Care Mission Cancer and Blood - Des Moines Clinic

    Des Moines, Iowa, 50309

  • Broadlawns Medical Center

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Henry Ford Health Saint John Hospital

    Detroit, Michigan, 48236

  • Essentia Health Saint Mary's - Detroit Lakes Clinic

    Detroit Lakes, Minnesota, 56501

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Kaiser Permanente Dublin

    Dublin, California, 94568

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Essentia Health Saint Mary's Medical Center

    Duluth, Minnesota, 55805

  • Miller-Dwan Hospital

    Duluth, Minnesota, 55805

  • Prisma Health Cancer Institute - Easley

    Easley, South Carolina, 29640

  • Henry Ford River District Hospital

    East China Township, Michigan, 48054

  • Marshfield Medical Center-EC Cancer Center

    Eau Claire, Wisconsin, 54701

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • AtlantiCare Surgery Center

    Egg Harbor, New Jersey, 08234

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Mountain Blue Cancer Care Center - Swedish

    Englewood, Colorado, 80113

  • Swedish Medical Center

    Englewood, Colorado, 80113

  • OSF Saint Francis Hospital and Medical Group

    Escanaba, Michigan, 49829

  • Essentia Health Cancer Center-South University Clinic

    Fargo, North Dakota, 58103

  • Sanford Broadway Medical Center

    Fargo, North Dakota, 58122

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122

  • Cancer Hematology Centers - Flint

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Kaiser Permanente-Fontana

    Fontana, California, 92335

  • UI Healthcare Mission Cancer and Blood - Fort Dodge

    Fort Dodge, Iowa, 50501

  • GenesisCare USA - FGO

    Fort Myers, Florida, 33905

  • Regional Cancer Center-Lee Memorial Health System

    Fort Myers, Florida, 33905

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Essentia Health - Fosston

    Fosston, Minnesota, 56542

  • Atrium Medical Center-Middletown Regional Hospital

    Franklin, Ohio, 45005-1066

  • Dayton Physicians LLC-Atrium

    Franklin, Ohio, 45005

  • Kaiser Permanente-Fremont

    Fremont, California, 94538

  • Kaiser Permanente-Fresno

    Fresno, California, 93720

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Tidelands Georgetown Memorial Hospital

    Georgetown, South Carolina, 29440

  • Aurora Health Care Germantown Health Center

    Germantown, Wisconsin, 53022

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • National Jewish Health-Western Hematology Oncology

    Golden, Colorado, 80401

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Aurora Cancer Care-Grafton

    Grafton, Wisconsin, 53024

  • Nebraska Cancer Specialists/Oncology Hematology West PC

    Grand Island, Nebraska, 68803

  • Corewell Health Grand Rapids Hospitals - Butterworth Hospital

    Grand Rapids, Michigan, 49503

  • Trinity Health Grand Rapids Hospital

    Grand Rapids, Michigan, 49503

  • Central Care Cancer Center - Great Bend

    Great Bend, Kansas, 67530

  • Benefis Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Banner North Colorado Medical Center

    Greeley, Colorado, 80631

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Cone Health Cancer Center

    Greensboro, North Carolina, 27403

  • Dayton Physicians LLC-Wayne

    Greenville, Ohio, 45331

  • Wayne Hospital

    Greenville, Ohio, 45331

  • Saint Francis Hospital

    Greenville, South Carolina, 29601

  • Prisma Health Cancer Institute - Butternut

    Greenville, South Carolina, 29605

  • Prisma Health Cancer Institute - Faris

    Greenville, South Carolina, 29605

  • Saint Francis Cancer Center

    Greenville, South Carolina, 29607

  • Prisma Health Cancer Institute - Eastside

    Greenville, South Carolina, 29615

  • Prisma Health Cancer Institute - Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Henry Ford Saint John Hospital - Academic

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Breast

    Grosse Pointe Woods, Michigan, 48236

  • Henry Ford Saint John Hospital - Van Elslander

    Grosse Pointe Woods, Michigan, 48236

  • Gulfport Memorial Hospital

    Gulfport, Mississippi, 39502

  • Kaiser Permanente South Bay

    Harbor City, California, 90710

  • Geisinger Medical Center-Cancer Center Hazleton

    Hazleton, Pennsylvania, 18201

  • Margaret R Pardee Memorial Hospital

    Hendersonville, North Carolina, 28791

  • Essentia Health Hibbing Clinic

    Hibbing, Minnesota, 55746

  • South Carolina Cancer Specialists PC

    Hilton Head Island, South Carolina, 29926-3827

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • Kaiser Permanente Moanalua Medical Center

    Honolulu, Hawaii, 96819

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Kaiser Permanente-Irvine

    Irvine, California, 92618

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Essentia Health - Jamestown Clinic

    Jamestown, North Dakota, 58401

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Northwest Cancer Clinic

    Kennewick, Washington, 99336

  • Aurora Cancer Care-Kenosha South

    Kenosha, Wisconsin, 53142

  • Greater Dayton Cancer Center

    Kettering, Ohio, 45409

  • First Dayton Cancer Care

    Kettering, Ohio, 45420

  • Kettering Medical Center

    Kettering, Ohio, 45429

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Marshfield Medical Center - Ladysmith

    Ladysmith, Wisconsin, 54848

  • Kaiser Permanente-Rock Creek

    Lafayette, Colorado, 80026

  • Northwell Health/Center for Advanced Medicine

    Lake Success, New York, 11042

  • University of Michigan Health - Sparrow Lansing

    Lansing, Michigan, 48912

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Kansas Institute of Medicine Cancer and Blood Center

    Lenexa, Kansas, 66219

  • Minimally Invasive Surgery Hospital

    Lenexa, Kansas, 66219

  • Geisinger Medical Oncology-Lewisburg

    Lewisburg, Pennsylvania, 17837

  • Lewistown Hospital

    Lewistown, Pennsylvania, 17044

  • Saint Joseph Hospital East

    Lexington, Kentucky, 40509

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Rocky Mountain Cancer Centers-Littleton

    Littleton, Colorado, 80120

  • Hope Cancer Clinic

    Livonia, Michigan, 48154

  • Trinity Health Saint Mary Mercy Livonia Hospital

    Livonia, Michigan, 48154

  • Logan Regional Hospital

    Logan, Utah, 84321

  • Kaiser Permanente-Lone Tree

    Lone Tree, Colorado, 80124

  • Rocky Mountain Cancer Centers-Sky Ridge

    Lone Tree, Colorado, 80124

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Kaiser Permanente West Los Angeles

    Los Angeles, California, 90034

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • Banner North Colorado Medical Center - Loveland Campus

    Loveland, Colorado, 80539

  • Henry Ford Saint John Hospital - Macomb Medical

    Macomb, Michigan, 48044

  • Henry Ford Warren Hospital - Breast Macomb

    Macomb, Michigan, 48044

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • OhioHealth Mansfield Hospital

    Mansfield, Ohio, 44903

  • Fairview Clinics and Surgery Center Maple Grove

    Maple Grove, Minnesota, 55369

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marietta Memorial Hospital

    Marietta, Ohio, 45750

  • Aurora Bay Area Medical Group-Marinette

    Marinette, Wisconsin, 54143

  • Saint Vincent Hospital Cancer Center at Marinette

    Marinette, Wisconsin, 54143

  • OhioHealth Marion General Hospital

    Marion, Ohio, 43302

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • Cone Heath Cancer Center at Mebane

    Mebane, North Carolina, 27302

  • Riddle Memorial Hospital

    Media, Pennsylvania, 19063

  • Aurora Cancer Care-Milwaukee

    Milwaukee, Wisconsin, 53209

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Aurora Sinai Medical Center

    Milwaukee, Wisconsin, 53233

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Medical Center - Minocqua

    Minocqua, Wisconsin, 54548

  • Community Medical Center

    Missoula, Montana, 59804

  • Kaiser Permanente-Modesto

    Modesto, California, 95356

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • Knox Community Hospital

    Mount Vernon, Ohio, 43050

  • Intermountain Medical Center

    Murray, Utah, 84107

  • Saint Alphonsus Cancer Care Center-Nampa

    Nampa, Idaho, 83687

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • Cancer Center of Western Wisconsin

    New Richmond, Wisconsin, 54017

  • New Ulm Medical Center

    New Ulm, Minnesota, 56073

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Lenox Hill Hospital

    New York, New York, 10075

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Licking Memorial Hospital

    Newark, Ohio, 43055

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Corewell Health Lakeland Hospitals - Niles Hospital

    Niles, Michigan, 49120

  • Kaiser Permanente-Oakland

    Oakland, California, 94611

  • Saint Vincent Hospital Cancer Center at Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • McKay-Dee Hospital Center

    Ogden, Utah, 84403

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Mercy Hospital Oklahoma City

    Oklahoma City, Oklahoma, 73120

  • Kaiser Permanente-Ontario

    Ontario, California, 91761

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Kaiser Permanente - Panorama City

    Panorama City, California, 91402

  • Paoli Memorial Hospital

    Paoli, Pennsylvania, 19301

  • Essentia Health - Park Rapids

    Park Rapids, Minnesota, 56470

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Michigan Healthcare Professionals Pontiac

    Pontiac, Michigan, 48341

  • Newland Medical Associates-Pontiac

    Pontiac, Michigan, 48341

  • Trinity Health Saint Joseph Mercy Oakland Hospital

    Pontiac, Michigan, 48341

  • Southern Ohio Medical Center

    Portsmouth, Ohio, 45662

  • Geisinger Cancer Services-Pottsville

    Pottsville, Pennsylvania, 17901

  • Harrison HealthPartners Hematology and Oncology-Poulsbo

    Poulsbo, Washington, 98370

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Utah Valley Regional Medical Center

    Provo, Utah, 84604

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Aurora Cancer Care-Racine

    Racine, Wisconsin, 53406

  • Kaiser Permanente-Redwood City

    Redwood City, California, 94063

  • Corewell Health Reed City Hospital

    Reed City, Michigan, 49677

  • Beebe Health Campus

    Rehoboth Beach, Delaware, 19971

  • Annie Penn Memorial Hospital

    Reidsville, North Carolina, 27320

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • Kaiser Permanente-Richmond

    Richmond, California, 94801

  • Kaiser Permanente-Riverside

    Riverside, California, 92505

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Henry Ford Rochester Hospital

    Rochester Hills, Michigan, 48309

  • Kaiser Permanente-Roseville

    Roseville, California, 95661

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823

  • Kaiser Permanente Sacramento Medical Center

    Sacramento, California, 95825

  • MyMichigan Medical Center Saginaw

    Saginaw, Michigan, 48601

  • Corewell Health Lakeland Hospitals - Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Corewell Health Lakeland Hospitals - Saint Joseph Hospital

    Saint Joseph, Michigan, 49085

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Kaiser Permanente-San Diego Zion

    San Diego, California, 92120

  • Kaiser Permanente-San Francisco

    San Francisco, California, 94115

  • Kaiser Permanente-Santa Teresa-San Jose

    San Jose, California, 95119

  • Kaiser Permanente San Leandro

    San Leandro, California, 94577

  • Kaiser Permanente-San Marcos

    San Marcos, California, 92078

  • Kaiser Permanente-San Rafael

    San Rafael, California, 94903

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Kaiser Permanente-Santa Rosa

    Santa Rosa, California, 95403

  • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler

    Savannah, Georgia, 31405

  • Community Medical Center

    Scranton, Pennsylvania, 18510

  • TidalHealth Nanticoke / Allen Cancer Center

    Seaford, Delaware, 19973

  • Geisinger Medical Oncology-Selinsgrove

    Selinsgrove, Pennsylvania, 17870

  • Prisma Health Cancer Institute - Seneca

    Seneca, South Carolina, 29672

Other trials in United States

About this study

Official title: Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer

This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Measure the ability of two dose levels of bupropion hydrochloride (bupropion), 150 or 300 mg of extended release, to improve sexual desire more than a placebo at 9 weeks (8 weeks on the target dose) as measured by the desire subscale of the female sexual function index (FSFI).

SECONDARY OBJECTIVES:

  1. Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm.

II. Evaluate the effect of 150 and 300 mg of bupropion extended release on the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale, PROMIS sexual desire and satisfaction measure, patient health questionnaire (PHQ)-4, and the FSFI total score, at 5 and 9 weeks, as well as the desire subscale score of the FSFI at 5 weeks.

III. Evaluate the effect of 150 and 300 mg of bupropion extended release on the global impression of change scale and the patient's perception of risk versus (vs.) benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose).

Patients are randomized to 1 of 3 arms.

Being tested
Bupropion 150 mg XL, Placebo
Medical subject headings
Breast Neoplasms, Uterine Cervical Neoplasms, Ovarian Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms

What participants receive

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

  • Bupropion 150 mg XLDrug

    Also called Amfebutamone, BUPROPION HYDROCHLORIDE, BW 323U66, Forfivo XL

    By mouth

  • PlaceboDrug

    By mouth

Study groups in NCT03180294
Study groupRoleWhat they receive
Bupropion 150 mgExperimentalOne Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule daily for 8 weeks; one placebo capsule daily for one 1 week (titration off).
Receives: Drug: Bupropion 150 mg XL; Drug: Placebo
Bupropion 300 mgExperimentalOne Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
Receives: Drug: Bupropion 150 mg XL
PlaceboPlacebo comparatorOne placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
Receives: Drug: Placebo

What is being measured

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

  1. Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")

    The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.

    Measured: Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

Secondary outcomes (9)

  1. Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score

    The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.

    Measured: Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)

  2. Change From Baseline at 5 Weeks in Desire Subscore of the FSFI ("Sexual Desire")

    The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.

    Measured: Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization)

  3. Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction")

    The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol.

    Measured: Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)

  4. Change From Baseline in FSFI Total Score ("Sexual Functioning")

    The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as "sexual functioning" in the protocol.

    Measured: Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)

  5. Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood")

    The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol.

    Measured: Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)

  6. Global Impression of Change at 9 Weeks ("Perception of Change")

    Participants are asked, "Since beginning the study agent, my desire of sexual intimacy is:" with seven possible answers of "very much better," "moderately better," "a little better," "about the same," "a little worse," "moderately worse," and "very much worse." The first three answers have been categorized as "Better' and the last three answers as "Not Better". This measure is referred to as "perception of change" in the protocol.

    Measured: 9 weeks from start of study treatment (within 21 days of randomization)

  7. Perception of Risk vs. Benefit at 9 Weeks

    Participants are asked, "Were the benefits of this treatment greater than any side effects?"

    Measured: 9 weeks from start of study treatment (within 21 days of randomization)

  8. Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study

    Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data.

    Measured: Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).

  9. Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks

    Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).

    Measured: 9 weeks from start of study treatment (within 21 days of randomization).

Timeline

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

  1. First posted8 Jun 2017
  2. Study start31 May 2017
  3. Primary completion22 Feb 2021
  4. Study completion22 Feb 2021

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 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
230 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03180294
Sponsor's protocol ID
NRG-CC004
Other IDs
NCI-2017-00344, NRG-CC004, NRG-CC004, UG1CA189867
Status last verified
Jun 2026
First submitted
6 Jun 2017
Last updated
10 Jul 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: NCI is committed to sharing data in accordance with NIH policy. For more details on how clinical trial data is shared, access the link to the NIH data sharing policy page.

Publications

  • Barton DL, Pugh SL, Ganz PA, Plaxe SC, Koontz BF, Carter J, Greyz-Yusupov N, Page SJ, Rowland KM Jr, Balcueva EP, Nabeel S, Basil JB, Hill ML, Muller CY, Bell MC, Deshmukh S, Kachnic LA. Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004. J Clin Oncol. 2022 Feb 1;40(4):324-334. doi: 10.1200/JCO.21.01473. Epub 2021 Dec 9.

    PubMed 34882500

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