ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03180294
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : April 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
NRG Oncology

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.

Condition or disease Intervention/treatment Phase
Breast Carcinoma Cervical Carcinoma Ovarian Carcinoma Postmenopausal Uterine Corpus Cancer Vaginal Carcinoma Vulvar Carcinoma Drug: Bupropion Hydrochloride Other: Placebo Phase 2

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).

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A: Patients receive bupropion hydrochloride orally (PO) once daily (QD) on days 1-63 and placebo PO QD on days 8-71.

ARM B: Patients receive bupropion hydrochloride PO QD on days 1-7 and 64-71, and twice daily (BID) on days 8-63.

ARM C: Patients receive placebo PO QD on days 1-7 and 64-71, and BID on days 8-63.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 234 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer
Actual Study Start Date : May 31, 2017
Estimated Primary Completion Date : October 30, 2019
Estimated Study Completion Date : May 31, 2027


Arm Intervention/treatment
Experimental: Arm A (bupropion hydrochloride, placebo)
Patients receive bupropion hydrochloride PO QD on days 1-63 and placebo PO QD on days 8-71.
Drug: Bupropion Hydrochloride
Given PO
Other Names:
  • Amfebutamone
  • BW 323U66
  • Forfivo XL
  • Wellbutrin
  • Zyban

Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy

Experimental: Arm B (bupropion hydrochloride)
Patients receive bupropion hydrochloride PO QD on days 1-7 and 64-71, and BID on days 8-63.
Drug: Bupropion Hydrochloride
Given PO
Other Names:
  • Amfebutamone
  • BW 323U66
  • Forfivo XL
  • Wellbutrin
  • Zyban

Placebo Comparator: Arm C (placebo)
Patients receive placebo PO QD on days 1-7 and 64-71, and BID on days 8-63.
Other: Placebo
Given PO
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy




Primary Outcome Measures :
  1. Change in sexual desire, as measured by the desire subscale of the female sexual function index [ Time Frame: Baseline up to 9 weeks ]
    Will be tested between both bupropion arms and the control arm using a t-test with each comparison having a 1-sided significance level of 0.05. Effect sizes between placebo and each treatment arm will be reported. The desire subscale will be scored at each data point according to the scoring guidelines.


Secondary Outcome Measures :
  1. Depressive mood as measured by the patient health questionnaire-4 [ Time Frame: Up to 9 weeks ]
    Depressive mood at each time point will be compared between the placebo and each intervention arm using a t-test, or Wilcoxon test if the data is non-normal, and compared at the one-sided 0.05 significance level.

  2. Fatigue as measured by Patient Reported Outcomes Measurement Information System fatigue scale [ Time Frame: Up to 9 weeks ]
    Will be compared between the placebo and each intervention arm using a t-test, or Wilcoxon test if the data is non-normal, and compared at the one-sided 0.05 significance level. Spearman correlation coefficients will be used to assess the association between fatigue and sexual desire, as measured by both the sexual desire subscale of the female sexual function index and the Patient Reported Outcomes Measurement Information System sexual desire and satisfaction measure, and sexual functioning, as measured by the female sexual function index total score at each time point.

  3. Incidence of adverse events including patient reported outcomes-Common Terminology Criteria for Adverse Events assessed using Common Terminology Criteria for Adverse Events 4.0 [ Time Frame: Up to 9 weeks ]
    Adverse events will also be assessed using patient reported outcomes-Common Terminology Criteria for Adverse Events items. Patient reported outcomes-Common Terminology Criteria for Adverse Events items of Interest that are associated with potential drug side effects, based on the well-documented adverse events of bupropion, include: tremors, dizziness, insomnia, headache, dry mouth, decreased appetite, nausea, and constipation. Counts of all adverse events by grade will be provided by treatment arm. Counts and frequencies will be provided for the worst grade adverse event experienced by the patient.

  4. Sexual desire as measured by the desire subscale of the female sexual function index [ Time Frame: Baseline up to 9 weeks ]
    Will include comparison of the placebo and intervention arms of the change from baseline to 5 weeks for both sexual desire tools as well as the change from baseline to 9 weeks using the Patient Reported Outcomes Measurement Information System sexual desire and satisfaction measure using a t-test, or Wilcoxon test if the data is non-normal, and compared at the one-sided 0.05 significance level.

  5. Sexual functioning as measured by the female sexual function index total score [ Time Frame: Baseline up to 9 weeks ]
    Will be compared between the placebo and each intervention arm using a t-test, or Wilcoxon test if the data is non-normal, and compared at the one-sided 0.05 significance level. Longitudinal trends in female sexual function index total score will be assessed using a mixed effects model with maximum likelihood estimation on the mean scores with treatment arm and Patient Reported Outcomes Measurement Information System fatigue score as covariates to assess the impact of treatment and fatigue.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 PHQ4 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 (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,
    • 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);
  • 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)
  • 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 SSRI?s 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 (i.e. Effexor 37.5 -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 PHQ4; 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: PHQ4, 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03180294


  Show 301 Study Locations
Sponsors and Collaborators
NRG Oncology
National Cancer Institute (NCI)
Investigators
Principal Investigator: Debra Barton NRG Oncology

Responsible Party: NRG Oncology
ClinicalTrials.gov Identifier: NCT03180294     History of Changes
Other Study ID Numbers: NRG-CC004
NCI-2017-00344 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
NRG-CC004 ( Other Identifier: NRG Oncology )
NRG-CC004 ( Other Identifier: DCP )
UG1CA189867 ( U.S. NIH Grant/Contract )
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Breast Neoplasms
Ovarian Neoplasms
Vulvar Neoplasms
Vaginal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Vaginal Diseases
Carcinoma
Breast Diseases
Skin Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Endocrine System Diseases
Gonadal Disorders
Vulvar Diseases
Bupropion
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents