Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

230

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started May 2017

Typical duration for phase_2

Geographic Reach

1 country

362 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.7 years study duration

Study Start

First participant enrolled

May 31, 2017

Completed

6 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2017

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed

3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 22, 2021

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed

1 year until next milestone

Results Posted

Study results publicly available

March 8, 2022

Completed

Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

3.7 years

First QC Date

June 6, 2017

Results QC Date

February 10, 2022

Last Update Submit

April 7, 2026

Conditions

Cervical Carcinoma Ovarian Carcinoma Postmenopausal Uterine Corpus Cancer Vaginal Carcinoma Vulvar Carcinoma Breast Carcinoma

Outcome Measures

Primary Outcomes (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.
Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)

Secondary Outcomes (9)

Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score
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")
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")
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")
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")
Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
+4 more secondary outcomes

Study Arms (3)

Bupropion 150 mg

EXPERIMENTAL

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 XLDrug: Placebo

Bupropion 300 mg

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Bupropion 150 mg XLDRUG

By mouth

Also known as: Amfebutamone, BUPROPION HYDROCHLORIDE, BW 323U66, Forfivo XL, Wellbutrin, Zyban

Bupropion 150 mgBupropion 300 mg

PlaceboDRUG

By mouth

Bupropion 150 mgPlacebo

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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:
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
+11 more criteria

You may not qualify if:

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
+4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

NRG Oncologylead
National Cancer Institute (NCI)collaborator

Study Sites (362)

Kaiser Permanente-Anaheim

Anaheim, California, 92806, United States

Location

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

Kaiser Permanente-Baldwin Park

Baldwin Park, California, 91706, United States

Location

Kaiser Permanente-Bellflower

Bellflower, California, 90706, United States

Location

Kaiser Permanente Dublin

Dublin, California, 94568, United States

Location

Kaiser Permanente-Fontana

Fontana, California, 92335, United States

Location

Kaiser Permanente-Fremont

Fremont, California, 94538, United States

Location

Kaiser Permanente-Fresno

Fresno, California, 93720, United States

Location

Kaiser Permanente South Bay

Harbor City, California, 90710, United States

Location

Kaiser Permanente-Irvine

Irvine, California, 92618, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Kaiser Permanente West Los Angeles

Los Angeles, California, 90034, United States

Location

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

Location

Kaiser Permanente-Modesto

Modesto, California, 95356, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

Kaiser Permanente-Ontario

Ontario, California, 91761, United States

Location

Kaiser Permanente - Panorama City

Panorama City, California, 91402, United States

Location

Kaiser Permanente-Redwood City

Redwood City, California, 94063, United States

Location

Kaiser Permanente-Richmond

Richmond, California, 94801, United States

Location

Kaiser Permanente-Riverside

Riverside, California, 92505, United States

Location

Kaiser Permanente-Roseville

Roseville, California, 95661, United States

Location

Kaiser Permanente Downtown Commons

Sacramento, California, 95814, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser Permanente Sacramento Medical Center

Sacramento, California, 95825, United States

Location

Kaiser Permanente-San Diego Zion

San Diego, California, 92120, United States

Location

Kaiser Permanente-San Francisco

San Francisco, California, 94115, United States

Location

Kaiser Permanente-Santa Teresa-San Jose

San Jose, California, 95119, United States

Location

Kaiser Permanente San Leandro

San Leandro, California, 94577, United States

Location

Kaiser Permanente-San Marcos

San Marcos, California, 92078, United States

Location

Kaiser Permanente-San Rafael

San Rafael, California, 94903, United States

Location

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

Kaiser Permanente-Santa Rosa

Santa Rosa, California, 95403, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Stockton

Stockton, California, 95210, United States

Location

Kaiser Permanente Medical Center-Vacaville

Vacaville, California, 95688, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Kaiser Permanente-Woodland Hills

Woodland Hills, California, 91367, United States

Location

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, 80012, United States

Location

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, 80304, United States

Location

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, 80907, United States

Location

Denver Health Medical Center

Denver, Colorado, 80204, United States

Location

Kaiser Permanente-Franklin

Denver, Colorado, 80205, United States

Location

National Jewish Health-Main Campus

Denver, Colorado, 80206, United States

Location

The Women's Imaging Center

Denver, Colorado, 80209, United States

Location

Rocky Mountain Cancer Centers-Midtown

Denver, Colorado, 80218, United States

Location

Saint Joseph Hospital - Cancer Centers of Colorado

Denver, Colorado, 80218, United States

Location

Rocky Mountain Cancer Centers-Rose

Denver, Colorado, 80220, United States

Location

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, 80113, United States

Location

Swedish Medical Center

Englewood, Colorado, 80113, United States

Location

National Jewish Health-Western Hematology Oncology

Golden, Colorado, 80401, United States

Location

Banner North Colorado Medical Center

Greeley, Colorado, 80631, United States

Location

Kaiser Permanente-Rock Creek

Lafayette, Colorado, 80026, United States

Location

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, 80120, United States

Location

Kaiser Permanente-Lone Tree

Lone Tree, Colorado, 80124, United States

Location

Rocky Mountain Cancer Centers-Sky Ridge

Lone Tree, Colorado, 80124, United States

Location

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, 80539, United States

Location

National Jewish Health-Northern Hematology Oncology

Thornton, Colorado, 80260, United States

Location

Intermountain Health Lutheran Hospital

Wheat Ridge, Colorado, 80401, United States

Location

Helen F Graham Cancer Center

Newark, Delaware, 19713, United States

Location

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713, United States

Location

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718, United States

Location

Beebe Health Campus

Rehoboth Beach, Delaware, 19971, United States

Location

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, 19973, United States

Location

GenesisCare USA - FGO

Fort Myers, Florida, 33905, United States

Location

Regional Cancer Center-Lee Memorial Health System

Fort Myers, Florida, 33905, United States

Location

Augusta University Medical Center

Augusta, Georgia, 30912, United States

Location

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

Savannah, Georgia, 31405, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza