Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo For Sexual Desire in Women With Breast or Gynecologic Cancer
Principal Investigator
Deb Barton, PhD RN
Status
Terminated
Date Opened To Accrual
May 31 2017
Date Closed to Accrual
April 24 2020
Disease Site
Symptom Management [CC]
Other
Phase
II
Developmental Therapeutics
No
Primary Objective
Measure the ability of two dose levels of 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 FSFI.
Patient Population
Patients with diagnosis of breast or gynecologic cancer (ovarian, endometrial, vulvar, cervical, and vaginal), with a score of <9 on the PHQ-F and a FSFI desire subscale baseline score that is less than 3.3.
Protocol Documents:
Available via the National Cancer Institute (NCI) Cancer Trials Support Unit (CTSU) website.
Target Accrual
234