NCT03180294

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Breast Carcinoma
• Cervical Carcinoma
• Ovarian Carcinoma
• Postmenopausal
• Uterine Corpus Cancer
• Vaginal Carcinoma
• Vulvar Carcinoma

Interventions

Type	Name	Description
DRUG	Bupropion 150 mg XL	By mouth
DRUG	Placebo	By mouth

Timeline

• Start date: 2017-05-31
• Primary completion: 2021-02-22
• Completion: 2021-02-22
• First posted: 2017-06-08
• Last updated: 2022-03-08
• Results posted: 2022-03-08

Locations

362 sites across 1 country: United States

Regulatory

• FDA-regulated drug study