Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer
Sponsor: NRG Oncology
This observational or N/A phase trial investigates Breast Carcinoma and Cervical Carcinoma and is currently completed. NRG Oncology leads this study, which shows 22 recorded versions since 2017 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.
Study Description(click to expand)PRIMARY OBJECTIVES:
I. Measure the ability of two dose levels of bupropion hydrochloride (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 female sexual function index (FSFI).
SECONDARY OBJECTIVES:
I. Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm.
II. Evaluate the effect of 150 and 300 mg of bupropion extended release on the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale, PROMIS sexual desire and satisfaction measure, patient health questionnaire (PHQ)-4, and the FSFI total score, at 5 and 9 weeks, as well as the desire subscale score of the FSFI at 5 weeks.
III. Evaluate the effect of 150 and 300 mg of bupropion extended release on the global impression of change scale and the patient's perception of risk versus (vs.) benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose).
Patients are randomized to 1 of 3 arms.
PRIMARY OBJECTIVES:
I. Measure the ability of two dose levels of bupropion hydrochloride (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 female sexual function index (FSFI).
SECONDARY OBJECTIVES:
I. Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm.
II. Evaluate the effect of 150 and 300 mg of bupropion extended release on the Patient Reported Outcomes Measurement Information System (PROMIS) fatigue scale, PROMIS sexual desire and satisfaction measure, patient health questionnaire (PHQ)-4, and the FSFI total score, at 5 and 9 weeks, as well as the desire subscale score of the FSFI at 5 weeks.
III. Evaluate the effect of 150 and 300 mg of bupropion extended release on the global impression of change scale and the patient's perception of risk versus (vs.) benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose).
Patients are randomized to 1 of 3 arms.
Status Flow
Change History
22 versions recorded-
Apr 28, 2026 — Present [daily]
Completed
Phase: PHASE2 → None
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Sep 2025 — Apr 2026 [monthly]
Completed PHASE2
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE2
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE2
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Apr 2022 — Jul 2024 [monthly]
Completed PHASE2
▶ Show 17 earlier versions
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Jun 2021 — Apr 2022 [monthly]
Completed PHASE2
Status: Active Not Recruiting → Completed
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Apr 2021 — Jun 2021 [monthly]
Active Not Recruiting PHASE2
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Jan 2021 — Apr 2021 [monthly]
Active Not Recruiting PHASE2
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Nov 2020 — Jan 2021 [monthly]
Active Not Recruiting PHASE2
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Aug 2020 — Nov 2020 [monthly]
Active Not Recruiting PHASE2
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May 2020 — Aug 2020 [monthly]
Active Not Recruiting PHASE2
Status: Recruiting → Active Not Recruiting
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Mar 2020 — May 2020 [monthly]
Recruiting PHASE2
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Oct 2019 — Mar 2020 [monthly]
Recruiting PHASE2
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Aug 2019 — Oct 2019 [monthly]
Recruiting PHASE2
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Jul 2019 — Aug 2019 [monthly]
Recruiting PHASE2
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Mar 2019 — Jul 2019 [monthly]
Recruiting PHASE2
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Feb 2019 — Mar 2019 [monthly]
Recruiting PHASE2
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Dec 2018 — Feb 2019 [monthly]
Recruiting PHASE2
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Sep 2018 — Dec 2018 [monthly]
Recruiting PHASE2
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Jun 2018 — Sep 2018 [monthly]
Recruiting PHASE2
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May 2018 — Jun 2018 [monthly]
Recruiting PHASE2
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Jun 2017 — May 2018 [monthly]
Recruiting PHASE2
First recorded
May 2017
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
This phase II randomized trial studies how well bupropion hydrochloride works in improving sexual desire in women with breast or gynecological cancer. Bupropion hydrochloride may work by boosting sexual desire, energy, or motivation without causing intolerable or undesirable side effects.
Contact Information
- NRG Oncology
- National Cancer Institute (NCI)
For direct contact, visit the study record on ClinicalTrials.gov .