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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

Primary Objective Measure the ability of two dose levels of 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 FSFI. 1.2 Secondary Objectives 1.2.1 Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm. 1.2.2 Evaluate the effect of 150 and 300 mg of bupropion extended release on the PROMIS fatigue scale, PROMIS sexual desire and satisfaction measure, 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. 1.2.3 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 vs. benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose).

Primary Objective Measure the ability of two dose levels of 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 FSFI. 1.2 Secondary Objectives 1.2.1 Evaluate the side effects of 150 and 300 mg bupropion extended release and differentiate these side effects from those observed in the placebo arm. 1.2.2 Evaluate the effect of 150 and 300 mg of bupropion extended release on the PROMIS fatigue scale, PROMIS sexual desire and satisfaction measure, 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. 1.2.3 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 vs. benefit at 5 weeks (4 weeks at target dose) and 9 weeks (8 weeks at target dose).