Randomized Controlled Phase II Evaluation of Two Dose Levels of Bupropion Versus Placebo for Sexual Desire in Female Cancer Survivors: NRG-CC004

J Clin Oncol. 2022 Feb 1;40(4):324-334. doi: 10.1200/JCO.21.01473. Epub 2021 Dec 9.


Purpose: Because of the negative impact of cancer treatment on female sexual function, effective treatments are warranted. The purpose of this multisite study was to evaluate the ability of two dose levels of extended-release bupropion, a dopaminergic agent, to improve sexual desire more than placebo at 9 weeks, measured by the desire subscale of the Female Sexual Function Index (FSFI), and to evaluate associated toxicities.

Methods: Postmenopausal women diagnosed with breast or gynecologic cancer and low baseline FSFI desire scores (< 3.3), who had completed definitive cancer therapy, were eligible. Women were randomly assigned to receive 150 mg or 300 mg once daily of extended-release bupropion or a matching placebo. t-tests were performed on the FSFI desire subscale to evaluate whether there was a significantly greater change from baseline to 9 weeks between placebo and each bupropion arm as the primary end point. Sixty-two patients per arm provided 80% power using a one-sided t-test.

Results: Two hundred thirty women were randomly assigned from 72 institutions through the NRG Oncology NCORP network. At 9 weeks, there were no statistically significant differences in change of the desire subscale scores between groups; participants in all three arms reported improvement. The mean changes for each arm were placebo 0.62 (standard deviation [SD] = 1.18), 150-mg once daily bupropion 0.64 (SD = 0.95), and 300-mg once daily bupropion 0.60 (SD = 0.89). Total and subscale scores on the FSFI were low throughout the study, indicating dysfunction in all groups.

Conclusion: Bupropion was not more effective than placebo in improving the desire subscale of the FSFI. Subscale and total scores of the FSFI demonstrated dysfunction throughout the 9 weeks of the study. More research is needed to support sexual function in female cancer survivors.

Trial registration: ClinicalTrials.gov NCT03180294.

Publication types

  • Clinical Trial, Phase II
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Breast Neoplasms / therapy*
  • Bupropion / administration & dosage*
  • Bupropion / adverse effects
  • Cancer Survivors / psychology*
  • Delayed-Action Preparations
  • Dopamine Uptake Inhibitors / administration & dosage*
  • Dopamine Uptake Inhibitors / adverse effects
  • Double-Blind Method
  • Female
  • Genital Neoplasms, Female / therapy*
  • Humans
  • Middle Aged
  • Patient Reported Outcome Measures
  • Patient Satisfaction
  • Postmenopause
  • Sexual Behavior / drug effects*
  • Sexual Dysfunctions, Psychological / diagnosis
  • Sexual Dysfunctions, Psychological / drug therapy*
  • Sexual Dysfunctions, Psychological / psychology
  • Time Factors
  • Treatment Outcome
  • United States


  • Delayed-Action Preparations
  • Dopamine Uptake Inhibitors
  • Bupropion

Associated data

  • ClinicalTrials.gov/NCT03180294