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

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.

Study Overview

• Status: Completed
• Conditions: Breast Carcinoma; Cervical Carcinoma; Vaginal Carcinoma; Ovarian Carcinoma; Uterine Corpus Cancer; Vulvar Carcinoma; Postmenopausal
• Intervention / Treatment: Drug: Bupropion 150 mg XL; Drug: Placebo

Detailed Description

PRIMARY OBJECTIVES:

I. 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:

I. 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.

• Study Type: Interventional
• Enrollment (Actual): 230
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92806
      • Kaiser Permanente-Anaheim
    • Antioch, California, United States, 94531
      • Kaiser Permanente-Deer Valley Medical Center
    • Baldwin Park, California, United States, 91706
      • Kaiser Permanente-Baldwin Park
    • Bellflower, California, United States, 90706
      • Kaiser Permanente-Bellflower
    • Dublin, California, United States, 94568
      • Kaiser Permanente Dublin
    • Fontana, California, United States, 92335
      • Kaiser Permanente-Fontana
    • Fremont, California, United States, 94538
      • Kaiser Permanente-Fremont
    • Fresno, California, United States, 93720
      • Kaiser Permanente-Fresno
    • Harbor City, California, United States, 90710
      • Kaiser Permanente - Harbor City
    • Irvine, California, United States, 92618
      • Kaiser Permanente-Irvine
    • Los Angeles, California, United States, 90095
      • UCLA / Jonsson Comprehensive Cancer Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90034
      • Kaiser Permanente-Cadillac
    • Modesto, California, United States, 95356
      • Kaiser Permanente-Modesto
    • Oakland, California, United States, 94611
      • Kaiser Permanente-Oakland
    • Ontario, California, United States, 91761
      • Kaiser Permanente-Ontario
    • Panorama City, California, United States, 91402
      • Kaiser Permanente - Panorama City
    • Redwood City, California, United States, 94063
      • Kaiser Permanente-Redwood City
    • Richmond, California, United States, 94801
      • Kaiser Permanente-Richmond
    • Riverside, California, United States, 92505
      • Kaiser Permanente-Riverside
    • Roseville, California, United States, 95661
      • Kaiser Permanente-Roseville
    • Sacramento, California, United States, 95814
      • Kaiser Permanente Downtown Commons
    • Sacramento, California, United States, 95823
      • Kaiser Permanente-South Sacramento
    • Sacramento, California, United States, 95825
      • Kaiser Permanente - Sacramento
    • San Diego, California, United States, 92120
      • Kaiser Permanente-San Diego Zion
    • San Francisco, California, United States, 94115
      • Kaiser Permanente-San Francisco
    • San Jose, California, United States, 95119
      • Kaiser Permanente-Santa Teresa-San Jose
    • San Leandro, California, United States, 94577
      • Kaiser Permanente San Leandro
    • San Marcos, California, United States, 92078
      • Kaiser Permanente-San Marcos
    • San Rafael, California, United States, 94903
      • Kaiser San Rafael-Gallinas
    • San Rafael, California, United States, 94903
      • Kaiser Permanente-San Rafael
    • Santa Clara, California, United States, 95051
      • Kaiser Permanente Medical Center - Santa Clara
    • Santa Rosa, California, United States, 95403
      • Kaiser Permanente-Santa Rosa
    • South San Francisco, California, United States, 94080
      • Kaiser Permanente-South San Francisco
    • Stockton, California, United States, 95210
      • Kaiser Permanente-Stockton
    • Vacaville, California, United States, 95688
      • Kaiser Permanente Medical Center-Vacaville
    • Vallejo, California, United States, 94589
      • Kaiser Permanente-Vallejo
    • Walnut Creek, California, United States, 94596
      • Kaiser Permanente-Walnut Creek
    • Woodland Hills, California, United States, 91367
      • Kaiser Permanente-Woodland Hills
  • Colorado
    • Aurora, Colorado, United States, 80012
      • Rocky Mountain Cancer Centers-Aurora
    • Boulder, Colorado, United States, 80304
      • Rocky Mountain Cancer Centers-Boulder
    • Colorado Springs, Colorado, United States, 80907
      • Penrose-Saint Francis Healthcare
    • Denver, Colorado, United States, 80205
      • Kaiser Permanente-Franklin
    • Denver, Colorado, United States, 80218
      • SCL Health Saint Joseph Hospital
    • Denver, Colorado, United States, 80218
      • Rocky Mountain Cancer Centers-Midtown
    • Denver, Colorado, United States, 80220
      • Rocky Mountain Cancer Centers-Rose
    • Denver, Colorado, United States, 80204
      • Denver Health Medical Center
    • Denver, Colorado, United States, 80209
      • The Women's Imaging Center
    • Denver, Colorado, United States, 80206
      • National Jewish Health-Main Campus
    • Englewood, Colorado, United States, 80113
      • Mountain Blue Cancer Care Center - Swedish
    • Englewood, Colorado, United States, 80113
      • Swedish Medical Center
    • Golden, Colorado, United States, 80401
      • National Jewish Health-Western Hematology Oncology
    • Greeley, Colorado, United States, 80631
      • North Colorado Medical Center
    • Lafayette, Colorado, United States, 80026
      • Kaiser Permanente-Rock Creek
    • Littleton, Colorado, United States, 80120
      • Rocky Mountain Cancer Centers-Littleton
    • Lone Tree, Colorado, United States, 80124
      • Kaiser Permanente-Lone Tree
    • Lone Tree, Colorado, United States, 80124
      • Rocky Mountain Cancer Centers-Sky Ridge
    • Loveland, Colorado, United States, 80539
      • McKee Medical Center
    • Thornton, Colorado, United States, 80260
      • National Jewish Health-Northern Hematology Oncology
    • Wheat Ridge, Colorado, United States, 80033
      • SCL Health Lutheran Medical Center
  • Delaware
    • Newark, Delaware, United States, 19713
      • Helen F Graham Cancer Center
    • Newark, Delaware, United States, 19713
      • Medical Oncology Hematology Consultants PA
    • Newark, Delaware, United States, 19718
      • Christiana Care Health System-Christiana Hospital
    • Rehoboth Beach, Delaware, United States, 19971
      • Beebe Health Campus
    • Seaford, Delaware, United States, 19973
      • TidalHealth Nanticoke / Allen Cancer Center
  • Florida
    • Fort Myers, Florida, United States, 33905
      • Regional Cancer Center-Lee Memorial Health System
    • Fort Myers, Florida, United States, 33905
      • Florida Gynecologic Oncology
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Augusta University Medical Center
    • Savannah, Georgia, United States, 31405
      • Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Pali Momi Medical Center
    • 'Aiea, Hawaii, United States, 96701
      • Queen's Cancer Center - Pearlridge
    • 'Aiea, Hawaii, United States, 96701
      • The Cancer Center of Hawaii-Pali Momi
    • Honolulu, Hawaii, United States, 96813
      • Queen's Medical Center
    • Honolulu, Hawaii, United States, 96817
      • The Cancer Center of Hawaii-Liliha
    • Honolulu, Hawaii, United States, 96813
      • Hawaii Cancer Care Inc - Waterfront Plaza
    • Honolulu, Hawaii, United States, 96813
      • Queen's Cancer Cenrer - POB I
    • Honolulu, Hawaii, United States, 96813
      • Straub Clinic and Hospital
    • Honolulu, Hawaii, United States, 96813
      • University of Hawaii Cancer Center
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Cancer Care Inc-Liliha
    • Honolulu, Hawaii, United States, 96817
      • Queen's Cancer Center - Kuakini
    • Honolulu, Hawaii, United States, 96826
      • Kapiolani Medical Center for Women and Children
    • Honolulu, Hawaii, United States, 96819
      • Kaiser Permanente Moanalua Medical Center
  • Idaho
    • Boise, Idaho, United States, 83706
      • Saint Alphonsus Cancer Care Center-Boise
    • Caldwell, Idaho, United States, 83605
      • Saint Alphonsus Cancer Care Center-Caldwell
    • Nampa, Idaho, United States, 83686
      • Saint Alphonsus Medical Center-Nampa
  • Illinois
    • Centralia, Illinois, United States, 62801
      • Centralia Oncology Clinic
    • Chicago, Illinois, United States, 60612
      • John H Stroger Jr Hospital of Cook County
    • Danville, Illinois, United States, 61832
      • Carle on Vermilion
    • Decatur, Illinois, United States, 62526
      • Decatur Memorial Hospital
    • Decatur, Illinois, United States, 62526
      • Cancer Care Specialists of Illinois - Decatur
    • Effingham, Illinois, United States, 62401
      • Crossroads Cancer Center
    • Urbana, Illinois, United States, 61801
      • Carle Cancer Center
  • Iowa
    • Cedar Rapids, Iowa, United States, 52402
      • Physicians' Clinic of Iowa PC
    • Des Moines, Iowa, United States, 50309
      • Iowa Methodist Medical Center
    • Des Moines, Iowa, United States, 50314
      • Mercy Medical Center - Des Moines
    • Des Moines, Iowa, United States, 50309
      • Medical Oncology and Hematology Associates-Des Moines
    • Des Moines, Iowa, United States, 50314
      • Broadlawns Medical Center
    • Des Moines, Iowa, United States, 50316
      • Iowa Lutheran Hospital
    • Fort Dodge, Iowa, United States, 50501
      • Trinity Regional Medical Center
    • Sioux City, Iowa, United States, 51101
      • Siouxland Regional Cancer Center
    • West Des Moines, Iowa, United States, 50266-7700
      • Methodist West Hospital
  • Kansas
    • Chanute, Kansas, United States, 66720
      • Cancer Center of Kansas - Chanute
    • Dodge City, Kansas, United States, 67801
      • Cancer Center of Kansas - Dodge City
    • El Dorado, Kansas, United States, 67042
      • Cancer Center of Kansas - El Dorado
    • Fort Scott, Kansas, United States, 66701
      • Cancer Center of Kansas - Fort Scott
    • Great Bend, Kansas, United States, 67530
      • Central Care Cancer Center - Great Bend
    • Independence, Kansas, United States, 67301
      • Cancer Center of Kansas-Independence
    • Kingman, Kansas, United States, 67068
      • Cancer Center of Kansas-Kingman
    • Lawrence, Kansas, United States, 66044
      • Lawrence Memorial Hospital
    • Lenexa, Kansas, United States, 66219
      • Kansas Institute of Medicine Cancer and Blood Center
    • Lenexa, Kansas, United States, 66219
      • Minimally Invasive Surgery Hospital
    • Liberal, Kansas, United States, 67905
      • Cancer Center of Kansas-Liberal
    • Manhattan, Kansas, United States, 66502
      • Cancer Center of Kansas-Manhattan
    • McPherson, Kansas, United States, 67460
      • Cancer Center of Kansas - McPherson
    • Newton, Kansas, United States, 67114
      • Cancer Center of Kansas - Newton
    • Parsons, Kansas, United States, 67357
      • Cancer Center of Kansas - Parsons
    • Pratt, Kansas, United States, 67124
      • Cancer Center of Kansas - Pratt
    • Salina, Kansas, United States, 67401
      • Cancer Center of Kansas - Salina
    • Wellington, Kansas, United States, 67152
      • Cancer Center of Kansas - Wellington
    • Wichita, Kansas, United States, 67214
      • Ascension Via Christi Hospitals Wichita
    • Wichita, Kansas, United States, 67208
      • Cancer Center of Kansas-Wichita Medical Arts Tower
    • Wichita, Kansas, United States, 67214
      • Cancer Center of Kansas - Wichita
    • Wichita, Kansas, United States, 67208
      • Associates In Womens Health
    • Winfield, Kansas, United States, 67156
      • Cancer Center of Kansas - Winfield
  • Kentucky
    • Bardstown, Kentucky, United States, 40004
      • Flaget Memorial Hospital
    • Lexington, Kentucky, United States, 40509
      • Saint Joseph Hospital East
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • University Medical Center New Orleans
    • New Orleans, Louisiana, United States, 70112
      • Louisiana State University Health Science Center
    • Shreveport, Louisiana, United States, 71103
      • Willis-Knighton Medical and Cancer Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48106
      • Saint Joseph Mercy Hospital
    • Battle Creek, Michigan, United States, 49017
      • Bronson Battle Creek
    • Brighton, Michigan, United States, 48114
      • Saint Joseph Mercy Brighton
    • Brighton, Michigan, United States, 48114
      • IHA Hematology Oncology Consultants-Brighton
    • Canton, Michigan, United States, 48188
      • Saint Joseph Mercy Canton
    • Canton, Michigan, United States, 48188
      • IHA Hematology Oncology Consultants-Canton
    • Chelsea, Michigan, United States, 48118
      • Saint Joseph Mercy Chelsea
    • Chelsea, Michigan, United States, 48118
      • IHA Hematology Oncology Consultants-Chelsea
    • Clarkston, Michigan, United States, 48346
      • Hematology Oncology Consultants-Clarkston
    • Clarkston, Michigan, United States, 48346
      • Newland Medical Associates-Clarkston
    • Detroit, Michigan, United States, 48236
      • Ascension Saint John Hospital
    • East China Township, Michigan, United States, 48054
      • Great Lakes Cancer Management Specialists-Doctors Park
    • Escanaba, Michigan, United States, 49829
      • Green Bay Oncology - Escanaba
    • Flint, Michigan, United States, 48503
      • Hurley Medical Center
    • Flint, Michigan, United States, 48503
      • Genesee Cancer and Blood Disease Treatment Center
    • Flint, Michigan, United States, 48503
      • Genesee Hematology Oncology PC
    • Flint, Michigan, United States, 48503
      • Genesys Hurley Cancer Institute
    • Grand Rapids, Michigan, United States, 49503
      • Spectrum Health at Butterworth Campus
    • Grand Rapids, Michigan, United States, 49503
      • Mercy Health Saint Mary's
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Academic Hematology Oncology Specialists
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
    • Grosse Pointe Woods, Michigan, United States, 48236
      • Michigan Breast Specialists-Grosse Pointe Woods
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center
    • Lansing, Michigan, United States, 48912
      • Sparrow Hospital
    • Livonia, Michigan, United States, 48154
      • Saint Mary Mercy Hospital
    • Livonia, Michigan, United States, 48154
      • Hope Cancer Clinic
    • Macomb, Michigan, United States, 48044
      • Great Lakes Cancer Management Specialists-Macomb Medical Campus
    • Macomb, Michigan, United States, 48044
      • Michigan Breast Specialists-Macomb Township
    • Niles, Michigan, United States, 49120
      • Lakeland Hospital Niles
    • Pontiac, Michigan, United States, 48341
      • Saint Joseph Mercy Oakland
    • Pontiac, Michigan, United States, 48341
      • 21st Century Oncology-Pontiac
    • Pontiac, Michigan, United States, 48341
      • Newland Medical Associates-Pontiac
    • Reed City, Michigan, United States, 49677
      • Spectrum Health Reed City Hospital
    • Rochester Hills, Michigan, United States, 48309
      • Great Lakes Cancer Management Specialists-Rochester Hills
    • Saginaw, Michigan, United States, 48601
      • Ascension Saint Mary's Hospital
    • Saint Joseph, Michigan, United States, 49085
      • Lakeland Medical Center Saint Joseph
    • Saint Joseph, Michigan, United States, 49085
      • Marie Yeager Cancer Center
    • Traverse City, Michigan, United States, 49684
      • Munson Medical Center
    • Warren, Michigan, United States, 48093
      • Saint John Macomb-Oakland Hospital
    • Warren, Michigan, United States, 48093
      • Great Lakes Cancer Management Specialists-Macomb Professional Building
    • Warren, Michigan, United States, 48093
      • Macomb Hematology Oncology PC
    • Wyoming, Michigan, United States, 49519
      • Metro Health Hospital
    • Ypsilanti, Michigan, United States, 48197
      • IHA Hematology Oncology Consultants-Ann Arbor
  • Minnesota
    • Brainerd, Minnesota, United States, 56401
      • Essentia Health Saint Joseph's Medical Center
    • Burnsville, Minnesota, United States, 55337
      • Fairview Ridges Hospital
    • Coon Rapids, Minnesota, United States, 55433
      • Mercy Hospital
    • Deer River, Minnesota, United States, 56636
      • Essentia Health - Deer River Clinic
    • Detroit Lakes, Minnesota, United States, 56501
      • Essentia Health Saint Mary's - Detroit Lakes Clinic
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Cancer Center
    • Duluth, Minnesota, United States, 55805
      • Essentia Health Saint Mary's Medical Center
    • Duluth, Minnesota, United States, 55805
      • Miller-Dwan Hospital
    • Edina, Minnesota, United States, 55435
      • Fairview Southdale Hospital
    • Fosston, Minnesota, United States, 56542
      • Essentia Health - Fosston
    • Fridley, Minnesota, United States, 55432
      • Unity Hospital
    • Hibbing, Minnesota, United States, 55746
      • Essentia Health Hibbing Clinic
    • Maple Grove, Minnesota, United States, 55369
      • Fairview Clinics and Surgery Center Maple Grove
    • Maplewood, Minnesota, United States, 55109
      • Saint John's Hospital - Healtheast
    • Maplewood, Minnesota, United States, 55109
      • Minnesota Oncology Hematology PA-Maplewood
    • Minneapolis, Minnesota, United States, 55415
      • Hennepin County Medical Center
    • Minneapolis, Minnesota, United States, 55407
      • Abbott-Northwestern Hospital
    • Minneapolis, Minnesota, United States, 55454
      • Health Partners Inc
    • Monticello, Minnesota, United States, 55362
      • Monticello Cancer Center
    • New Ulm, Minnesota, United States, 56073
      • New Ulm Medical Center
    • Park Rapids, Minnesota, United States, 56470
      • Essentia Health - Park Rapids
    • Robbinsdale, Minnesota, United States, 55422
      • North Memorial Medical Health Center
    • Saint Louis Park, Minnesota, United States, 55416
      • Park Nicollet Clinic - Saint Louis Park
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital
    • Saint Paul, Minnesota, United States, 55102
      • United Hospital
    • Shakopee, Minnesota, United States, 55379
      • Saint Francis Regional Medical Center
    • Stillwater, Minnesota, United States, 55082
      • Lakeview Hospital
    • Virginia, Minnesota, United States, 55792
      • Essentia Health Virginia Clinic
    • Waconia, Minnesota, United States, 55387
      • Ridgeview Medical Center
    • Willmar, Minnesota, United States, 56201
      • Rice Memorial Hospital
    • Woodbury, Minnesota, United States, 55125
      • Minnesota Oncology Hematology PA-Woodbury
    • Wyoming, Minnesota, United States, 55092
      • Fairview Lakes Medical Center
  • Mississippi
    • Gulfport, Mississippi, United States, 39502
      • Gulfport Memorial Hospital
  • Missouri
    • Ballwin, Missouri, United States, 63011
      • Saint Louis Cancer and Breast Institute-Ballwin
    • Cape Girardeau, Missouri, United States, 63703
      • Saint Francis Medical Center
    • Saint Louis, Missouri, United States, 63131
      • Missouri Baptist Medical Center
    • Saint Louis, Missouri, United States, 63141
      • Mercy Hospital Saint Louis
    • Saint Louis, Missouri, United States, 63109
      • Saint Louis Cancer and Breast Institute-South City
    • Springfield, Missouri, United States, 65807
      • CoxHealth South Hospital
    • Springfield, Missouri, United States, 65804
      • Mercy Hospital Springfield
  • Montana
    • Billings, Montana, United States, 59101
      • Billings Clinic Cancer Center
    • Bozeman, Montana, United States, 59715
      • Bozeman Deaconess Hospital
    • Great Falls, Montana, United States, 59405
      • Benefis Healthcare- Sletten Cancer Institute
    • Missoula, Montana, United States, 59804
      • Community Medical Hospital
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • CHI Health Saint Francis
  • New Jersey
    • Cape May Court House, New Jersey, United States, 08210
      • AtlantiCare Health Park-Cape May Court House
    • Egg Harbor Township, New Jersey, United States, 08234
      • AtlantiCare Surgery Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • University of New Mexico Cancer Center
  • New York
    • Bay Shore, New York, United States, 11706
      • Northwell Health Imbert Cancer Center
    • Lake Success, New York, United States, 11042
      • Northwell Health/Center for Advanced Medicine
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • New York, New York, United States, 10021
      • Lenox Hill Hospital
  • North Carolina
    • Asheboro, North Carolina, United States, 27203
      • Randolph Hospital
    • Burlington, North Carolina, United States, 27215
      • Cone Health Cancer Center at Alamance Regional
    • Clinton, North Carolina, United States, 28328
      • Southeastern Medical Oncology Center-Clinton
    • Goldsboro, North Carolina, United States, 27534
      • Southeastern Medical Oncology Center-Goldsboro
    • Greensboro, North Carolina, United States, 27403
      • Cone Health Cancer Center
    • Hendersonville, North Carolina, United States, 28791
      • Margaret R Pardee Memorial Hospital
    • Jacksonville, North Carolina, United States, 28546
      • Southeastern Medical Oncology Center-Jacksonville
    • Mebane, North Carolina, United States, 27302
      • Cone Heath Cancer Center at Mebane
    • Reidsville, North Carolina, United States, 27320
      • Annie Penn Memorial Hospital
  • North Dakota
    • Bismarck, North Dakota, United States, 58501
      • Sanford Bismarck Medical Center
    • Fargo, North Dakota, United States, 58122
      • Sanford Roger Maris Cancer Center
    • Fargo, North Dakota, United States, 58103
      • Essentia Health Cancer Center-South University Clinic
    • Fargo, North Dakota, United States, 58122
      • Sanford Broadway Medical Center
    • Jamestown, North Dakota, United States, 58401
      • Essentia Health - Jamestown Clinic
  • Ohio
    • Beavercreek, Ohio, United States, 45431
      • Indu and Raj Soin Medical Center
    • Belpre, Ohio, United States, 45714
      • Strecker Cancer Center-Belpre
    • Centerville, Ohio, United States, 45459
      • Miami Valley Hospital South
    • Centerville, Ohio, United States, 45459
      • Dayton Physicians LLC-Miami Valley South
    • Chillicothe, Ohio, United States, 45601
      • Adena Regional Medical Center
    • Cincinnati, Ohio, United States, 45220
      • Good Samaritan Hospital - Cincinnati
    • Cincinnati, Ohio, United States, 45242
      • Bethesda North Hospital
    • Cincinnati, Ohio, United States, 45247
      • TriHealth Cancer Institute-Westside
    • Cincinnati, Ohio, United States, 45255
      • TriHealth Cancer Institute-Anderson
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43219
      • The Mark H Zangmeister Center
    • Columbus, Ohio, United States, 43214
      • Columbus Oncology and Hematology Associates Inc
    • Columbus, Ohio, United States, 43228
      • Doctors Hospital
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center
    • Dayton, Ohio, United States, 45406
      • Good Samaritan Hospital - Dayton
    • Dayton, Ohio, United States, 45409
      • Miami Valley Hospital
    • Dayton, Ohio, United States, 45415
      • Dayton Physician LLC-Miami Valley Hospital North
    • Dayton, Ohio, United States, 45415
      • Miami Valley Hospital North
    • Dayton, Ohio, United States, 45428
      • Dayton Veterans Affairs Medical Center
    • Delaware, Ohio, United States, 43015
      • Delaware Health Center-Grady Cancer Center
    • Franklin, Ohio, United States, 45005-1066
      • Atrium Medical Center-Middletown Regional Hospital
    • Franklin, Ohio, United States, 45005
      • Dayton Physicians LLC-Atrium
    • Greenville, Ohio, United States, 45331
      • Wayne Hospital
    • Greenville, Ohio, United States, 45331
      • Dayton Physicians LLC-Wayne
    • Kettering, Ohio, United States, 45429
      • Kettering Medical Center
    • Kettering, Ohio, United States, 45409
      • Greater Dayton Cancer Center
    • Kettering, Ohio, United States, 45420
      • First Dayton Cancer Care
    • Mansfield, Ohio, United States, 44903
      • OhioHealth Mansfield Hospital
    • Marietta, Ohio, United States, 45750
      • Marietta Memorial Hospital
    • Marion, Ohio, United States, 43302
      • OhioHealth Marion General Hospital
    • Mount Vernon, Ohio, United States, 43050
      • Knox Community Hospital
    • Newark, Ohio, United States, 43055
      • Licking Memorial Hospital
    • Portsmouth, Ohio, United States, 45662
      • Southern Ohio Medical Center
    • Springfield, Ohio, United States, 45505
      • Springfield Regional Medical Center
    • Springfield, Ohio, United States, 45504
      • Springfield Regional Cancer Center
    • Troy, Ohio, United States, 45373
      • Upper Valley Medical Center
    • Troy, Ohio, United States, 45373
      • Dayton Physicians LLC-Upper Valley
    • Westerville, Ohio, United States, 43081
      • Saint Ann's Hospital
    • Zanesville, Ohio, United States, 43701
      • Genesis Healthcare System Cancer Care Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
    • Oklahoma City, Oklahoma, United States, 73120
      • Mercy Hospital Oklahoma City
  • Pennsylvania
    • Bryn Mawr, Pennsylvania, United States, 19010
      • Bryn Mawr Hospital
    • Danville, Pennsylvania, United States, 17822
      • Geisinger Medical Center
    • Hazleton, Pennsylvania, United States, 18201
      • Geisinger Medical Center-Cancer Center Hazleton
    • Lewisburg, Pennsylvania, United States, 17837
      • Geisinger Medical Oncology-Lewisburg
    • Lewistown, Pennsylvania, United States, 17044
      • Lewistown Hospital
    • Media, Pennsylvania, United States, 19063
      • Riddle Memorial Hospital
    • Paoli, Pennsylvania, United States, 19301
      • Paoli Memorial Hospital
    • Pottsville, Pennsylvania, United States, 17901
      • Geisinger Cancer Services-Pottsville
    • Scranton, Pennsylvania, United States, 18510
      • Community Medical Center
    • Selinsgrove, Pennsylvania, United States, 17870
      • Geisinger Medical Oncology-Selinsgrove
    • State College, Pennsylvania, United States, 16801
      • Geisinger Medical Group
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Geisinger Wyoming Valley/Henry Cancer Center
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • South Carolina
    • Boiling Springs, South Carolina, United States, 29316
      • Prisma Health Cancer Institute - Spartanburg
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
    • Clinton, South Carolina, United States, 29325
      • Prisma Health Cancer Institute - Laurens
    • Easley, South Carolina, United States, 29640
      • Prisma Health Cancer Institute - Easley
    • Gaffney, South Carolina, United States, 29341
      • Gibbs Cancer Center-Gaffney
    • Georgetown, South Carolina, United States, 29440
      • Tidelands Georgetown Memorial Hospital
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Faris
    • Greenville, South Carolina, United States, 29607
      • Saint Francis Cancer Center
    • Greenville, South Carolina, United States, 29615
      • Prisma Health Cancer Institute - Eastside
    • Greenville, South Carolina, United States, 29605
      • Prisma Health Cancer Institute - Butternut
    • Greenville, South Carolina, United States, 29601
      • Saint Francis Hospital
    • Greer, South Carolina, United States, 29650
      • Prisma Health Cancer Institute - Greer
    • Greer, South Carolina, United States, 29651
      • Gibbs Cancer Center-Pelham
    • Hilton Head Island, South Carolina, United States, 29926-3827
      • South Carolina Cancer Specialists PC
    • Seneca, South Carolina, United States, 29672
      • Prisma Health Cancer Institute - Seneca
    • Spartanburg, South Carolina, United States, 29303
      • Spartanburg Medical Center
    • Union, South Carolina, United States, 29379
      • MGC Hematology Oncology-Union
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57117-5134
      • Sanford USD Medical Center - Sioux Falls
    • Sioux Falls, South Dakota, United States, 57104
      • Sanford Cancer Center Oncology Clinic
  • Texas
    • Bryan, Texas, United States, 77802
      • Saint Joseph Regional Cancer Center
  • Utah
    • American Fork, Utah, United States, 84003
      • American Fork Hospital / Huntsman Intermountain Cancer Center
    • Logan, Utah, United States, 84321
      • Logan Regional Hospital
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
    • Ogden, Utah, United States, 84403
      • McKay-Dee Hospital Center
    • Provo, Utah, United States, 84604
      • Utah Valley Regional Medical Center
  • Washington
    • Auburn, Washington, United States, 98001
      • MultiCare Auburn Medical Center
    • Bremerton, Washington, United States, 98310
      • Harrison HealthPartners Hematology and Oncology-Bremerton
    • Gig Harbor, Washington, United States, 98335
      • MultiCare Gig Harbor Medical Park
    • Kennewick, Washington, United States, 99336
      • Northwest Cancer Clinic
    • Poulsbo, Washington, United States, 98370
      • Harrison HealthPartners Hematology and Oncology-Poulsbo
    • Puyallup, Washington, United States, 98372
      • MultiCare Good Samaritan Hospital
    • Tacoma, Washington, United States, 98405
      • MultiCare Tacoma General Hospital
  • Wisconsin
    • Ashland, Wisconsin, United States, 54806
      • Duluth Clinic Ashland
    • Burlington, Wisconsin, United States, 53105
      • Aurora Cancer Care-Southern Lakes VLCC
    • Chippewa Falls, Wisconsin, United States, 54729
      • Marshfield Clinic-Chippewa Center
    • Eau Claire, Wisconsin, United States, 54701
      • Marshfield Medical Center-EC Cancer Center
    • Fond Du Lac, Wisconsin, United States, 54937
      • Aurora Health Center-Fond du Lac
    • Germantown, Wisconsin, United States, 53022
      • Aurora Health Care Germantown Health Center
    • Grafton, Wisconsin, United States, 53024
      • Aurora Cancer Care-Grafton
    • Green Bay, Wisconsin, United States, 54311
      • Aurora BayCare Medical Center
    • Green Bay, Wisconsin, United States, 54301
      • Saint Vincent Hospital Cancer Center Green Bay
    • Green Bay, Wisconsin, United States, 54303
      • Saint Vincent Hospital Cancer Center at Saint Mary's
    • Kenosha, Wisconsin, United States, 53142
      • Aurora Cancer Care-Kenosha South
    • La Crosse, Wisconsin, United States, 54601
      • Gundersen Lutheran Medical Center
    • Ladysmith, Wisconsin, United States, 54848
      • Marshfield Clinic - Ladysmith Center
    • Manitowoc, Wisconsin, United States, 54221
      • Holy Family Memorial Hospital
    • Marinette, Wisconsin, United States, 54143
      • Aurora Bay Area Medical Group-Marinette
    • Marinette, Wisconsin, United States, 54143
      • Saint Vincent Hospital Cancer Center at Marinette
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Medical Center-Marshfield
    • Milwaukee, Wisconsin, United States, 53209
      • Aurora Cancer Care-Milwaukee
    • Milwaukee, Wisconsin, United States, 53215
      • Aurora Saint Luke's Medical Center
    • Milwaukee, Wisconsin, United States, 53233
      • Aurora Sinai Medical Center
    • Minocqua, Wisconsin, United States, 54548
      • Marshfield Clinic-Minocqua Center
    • New Richmond, Wisconsin, United States, 54017
      • Cancer Center of Western Wisconsin
    • Oconto Falls, Wisconsin, United States, 54154
      • Saint Vincent Hospital Cancer Center at Oconto Falls
    • Oshkosh, Wisconsin, United States, 54904
      • Vince Lombardi Cancer Clinic - Oshkosh
    • Racine, Wisconsin, United States, 53406
      • Aurora Cancer Care-Racine
    • Rice Lake, Wisconsin, United States, 54868
      • Marshfield Medical Center-Rice Lake
    • Sheboygan, Wisconsin, United States, 53081
      • Vince Lombardi Cancer Clinic-Sheboygan
    • Sheboygan, Wisconsin, United States, 53081
      • HSHS Saint Nicholas Hospital
    • Stevens Point, Wisconsin, United States, 54482
      • Marshfield Clinic Stevens Point Center
    • Sturgeon Bay, Wisconsin, United States, 54235-1495
      • Saint Vincent Hospital Cancer Center at Sturgeon Bay
    • Summit, Wisconsin, United States, 53066
      • Aurora Medical Center in Summit
    • Two Rivers, Wisconsin, United States, 54241
      • Vince Lombardi Cancer Clinic-Two Rivers
    • Wausau, Wisconsin, United States, 54401
      • Marshfield Clinic-Wausau Center
    • Wauwatosa, Wisconsin, United States, 53226
      • Aurora Cancer Care-Milwaukee West
    • West Allis, Wisconsin, United States, 53227
      • Aurora West Allis Medical Center
    • Weston, Wisconsin, United States, 54476
      • Marshfield Medical Center - Weston
    • Wisconsin Rapids, Wisconsin, United States, 54494
      • Marshfield Clinic - Wisconsin Rapids Center
  • Wyoming
    • Cheyenne, Wyoming, United States, 82001
      • Cheyenne Regional Medical Center-West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• 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)

• 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

Exclusion Criteria:

• 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
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Bupropion 150 mg; One 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).	Drug: Bupropion 150 mg XL; By mouth; Other Names: Wellbutrin; Zyban; Amfebutamone; BW 323U66; Forfivo XL; BUPROPION HYDROCHLORIDE; Drug: Placebo; By mouth
EXPERIMENTAL: Bupropion 300 mg; One 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)	Drug: Bupropion 150 mg XL; By mouth; Other Names: Wellbutrin; Zyban; Amfebutamone; BW 323U66; Forfivo XL; BUPROPION HYDROCHLORIDE
PLACEBO_COMPARATOR: Placebo; One 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)	Drug: Placebo; By mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
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.	Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization)
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.	Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
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.	Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
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.	Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
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.	9 weeks from start of study treatment (within 21 days of randomization)
Perception of Risk vs. Benefit at 9 Weeks	Participants are asked, "Were the benefits of this treatment greater than any side effects?"	9 weeks from start of study treatment (within 21 days of randomization)
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.	Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).
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).	9 weeks from start of study treatment (within 21 days of randomization).

Collaborators and Investigators

• Sponsor: NRG Oncology
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Debra Barton, NRG Oncology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 31, 2017
• Primary Completion (ACTUAL): February 22, 2021
• Study Completion (ACTUAL): February 22, 2021

Study Registration Dates

• First Submitted: June 6, 2017
• First Submitted That Met QC Criteria: June 6, 2017
• First Posted (ACTUAL): June 8, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 8, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Breast Diseases; Vaginal Diseases; Vulvar Diseases; Breast Neoplasms; Carcinoma; Vulvar Neoplasms; Vaginal Neoplasms; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Cytochrome P-450 Enzyme Inhibitors; Antidepressive Agents, Second-Generation; Cytochrome P-450 CYP2D6 Inhibitors; Dopamine Uptake Inhibitors; Bupropion
• Other Study ID Numbers: NRG-CC004 (OTHER: DCP); UG1CA189867 (U.S. NIH Grant/Contract); NCI-2017-00344 (REGISTRY: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No