NRG-CC004 ancillary data study-Exploring the effect of bupropion on sexual desire in female cancer survivors with and without vulvovaginal symptoms Journal Article


Authors: Carter, J.; Pugh, S. L.; Arring, N.; Littell, R. D.; Page, S. J.; Rowland, K. M.; Goodman, J. R.; Razaq, W.; Siddique, S.; Borges, M.; Kachnic, L. A.; Barton, D. L.
Article Title: NRG-CC004 ancillary data study-Exploring the effect of bupropion on sexual desire in female cancer survivors with and without vulvovaginal symptoms
Abstract: Background: Female cancer survivors often experience estrogen-deprivation symptoms, which may lead to decreases in sexual desire, vulvovaginal health (lubrication, dryness, discomfort), and sexual satisfaction. Interventions are needed to address these concerns. Aim: The objective of this secondary analysis was to determine if women with higher (better) scores on the Female Sexual Function Index (FSFI) lubrication and pain subscales reported higher desire scores based on treatment with bupropion vs placebo. Methods: Participants were part of NRG Oncology's NRG-CC004 (NCT03180294), a randomized placebo-controlled clinical trial evaluating bupropion (150 vs 300 mg) to improve sexual desire in survivors of breast or gynecologic cancer. All participants with baseline data from the FSFI lubrication, pain, and desire subscales with 5- and/or 9-week data were analyzed. The FSFI subscale scores were correlated using Spearman correlation coefficients. Logistic regression was used to determine associations between FSFI desire and other FSFI subscales while accounting for treatment arm and other covariates. Outcomes: The primary outcome of NRG Oncology's NRG-CC004 (NCT03180294) randomized phase II dose-finding trial was change from baseline to 9 weeks on the FSFI desire subscale score. Similar to the parent study, the primary outcome for this ancillary data study was the FSFI desire subscale score at 5 and 9 weeks. Results: Overall, 230 participants completed the FSFI at baseline and 189 at 9 weeks. The strongest correlations were between lubrication and pain at baseline (all participants, rho = 0.77; bupropion arms, rho = 0.82), week 5 (all participants, rho = 0.71; bupropion arms, rho = 0.68), and week 9 (all participants, rho = 0.75; bupropion arms, rho = 0.78), and the weakest correlations were between desire and pain. In patients in the treatment arms there were no interactions between lubrication or pain. The impact of various covariates on the FSFI score for desire at 9 weeks demonstrated that participants of non-White race (odds ratio [OR], 0.42; 95% CI, 0.21-0.81; P = .010), with a high lubrication score (OR, 0.36; 95% CI, 0.21-0.61; P = .0002), with a high pain score (less pain) (OR, 0.50; 95% CI, 0.29-0.87; P = .014), or with prior pelvic surgery (OR, 0.38; 95% CI, 0.23-0.63; P = .0002) had lower odds of having low desire. Clinical Implications: Acute estrogen-deprivation symptoms should be addressed prior to sexual desire intervention. Strengths and Limitations: This secondary analysis was not powered to examine all variables. Conclusion: Lubrication and pain were predictors of low desire. Therefore, vulvovaginal atrophy and associated genitourinary symptoms of menopause such as vaginal dryness and dyspareunia should be addressed prior to or in parallel with interventions for sexual desire. © The Author(s) 2024. Published by Oxford University Press on behalf of The International Society of Sexual Medicine. All rights reserved.
Keywords: adult; controlled study; aged; middle aged; pain; breast cancer; randomized controlled trial; dyspareunia; vaginal dryness; psychology; drug effect; breast neoplasms; cancer survivor; genital neoplasms, female; sexual dysfunction; breast tumor; survivorship; drug therapy; menopause; double blind procedure; double-blind method; gynecologic cancer; sexual function; libido; sexual behavior; female genital tract tumor; pelvis surgery; amfebutamone; cancer survivors; randomized controlled trial (topic); clinical trial (topic); female sexual function index; sexual dysfunction, physiological; female genital tract cancer; complication; vagina atrophy; sexual desire; lubrication; intention to treat analysis; cancer; humans; human; female; article; vulvovaginal disease; bupropion
Journal Title: Journal of Sexual Medicine
Volume: 21
Issue: 8
ISSN: 1743-6095
Publisher: Elsevier Inc.  
Date Published: 2024-08-01
Start Page: 709
End Page: 715
Language: English
DOI: 10.1093/jsxmed/qdae061
PUBMED: 38856026
PROVIDER: scopus
PMCID: PMC11294673
DOI/URL:
Notes: Source: Scopus
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  1. Jeanne Carter
    159 Carter