drugset / Trial / NCT07596212

BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder

NCT07596212

Phase 1/2 Not yet recruiting 100 enrolled University of Illinois at Chicago
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is open to women who have early-stage breast cancer and are on aromatase inhibitor (AI) therapy, and who have hypoactive sexual desire disorder (HSDD). HSDD is a persistent lack of physical desire for sex and a lack of sexual activity, or even sexual thoughts or fantasies, that causes you distress. The researchers want to determine if sexual functioning, as measured by responses on a sexual functioning questionnaire, is improved by adding Bupropion Extended Release (XL) to the AI treatment regimen. Bupropion XL is an FDA-approved medication for the treatment of major depressive disorder, seasonal affective disorder, and nicotine dependence. It has been studied in HSDD in pre- and post-menopausal healthy women, and has been demonstrated to be effective, but it has not been thoroughly studied in women with early-stage breast cancer on AI therapy.

Timeline

Start
2026-07
Primary completion
2028-07
Completion
2031-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Bupropion Small molecule 150 mg Oral
Subject Bupropion Small molecule 300 mg Oral
Background Anastrozole Other / unclassified
Background Exemestane Small molecule
Background Goserelin Other / unclassified Subcutaneous
Background Letrozole Other / unclassified
Background Leuprolide Other / unclassified Subcutaneous