NRG-CC004

Terminated

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Protocol Information

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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

Principal Investigator

Deb Barton, PhD RN

Status

Terminated

Open to Accrual

May 31, 2017

Closed to Accrual

April 24, 2020

Closed to Accrual & Treatment

July 29, 2020

Complete

February 22, 2021

Terminated

February 22, 2021


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.

Webinar Materials:

Webinar Slides

Target Accrual

234

Patient Study Webpage

To learn more about this study, visit the Patient Study Webpage.