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Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire In Women With Breast or Gynecologic Cancer
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire In Women With Breast or Gynecologic Cancer
 
Region Sponsors
Colorado
NRG Oncology
 
Acronym KP IRB No.
1226931
 
Study Type Phase
Clinical Trial Phase II
 
Study Population Description
Breast Carcinoma; Cervical Carcinoma; Ovarian Carcinoma; Postmenopausal; Uterine Corpus Cancer; Vaginal Carcinoma; Vulvar Carcinoma;
 
Purpose
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.
 
Detailed Description
 
Gender Age Limit
Female
 
Inclusion Criteria
  • 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
  • Please contact study personnel for more inclusion criteria
 
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

 
Keywords and/or Specific Medical Conditions
  • Breast Cancer
  • Gynecologic Oncology
  • Gynecologic Cancer
  • Oncology (Adult)
 
KP Clinical Facility
  • Franklin Medical Offices - Denver
  • Lone Tree Medical Offices - Lone Tree
  • Rock Creek Medical Offices - Lafayette
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Alex R Menter, MD
Contact Information:
- Patricia L Bourie
-303-649-5281
-Patricia.L.Bourie@kp.org
-Lone Tree Medical Offices - Lone Tree


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