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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

Status
Active
Cancer Type
Breast Cancer
Cervical Cancer
Gynecologic Cancers
Ovarian Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Female
Study Type
Supportive care
NCD ID
NCT03180294
Protocol IDs
NRG-CC004 (primary)
NRG-CC004
NRG-CC004
NCI-2017-00344
Study Sponsor
NRG Oncology

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.

Objectives

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).

OUTLINE: Patients are randomized to 1 of 3 arms.

ARM A: Patients receive bupropion hydrochloride orally (PO) once daily (QD) on days 1-63 and placebo PO QD on days 8-71.

ARM B: Patients receive bupropion hydrochloride PO QD on days 1-7 and 64-71, and twice daily (BID) on days 8-63.

ARM C: Patients receive placebo PO QD on days 1-7 and 64-71, and BID on days 8-63.
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