Study ID: NRG CC004
The purpose of this study is to see if the drug bupropion can improve sexual desire for postmenopausal women who have been diagnosed with breast cancer or gynecologic cancer (ovarian, endometrial, vulvar, cervical or vaginal) and to evaluate the side effects of the drug. Patients will be randomized into three groups:
- A – receives bupropion + placebo
- B – receives only bupropion
- C – receives placebo only
Please note: Women on the drug Tamoxifen are not eligible.
This is a phase II, double-blind, dose-finding trial of bupropion vs. placebo for sexual desire in women with breast or gynecologic cancer.
- Score of <9 on the PHQ-4; FSFI desire subscale baseline score less than 3.3
- Diagnosis of breast or gynecologic cancer (ovarian, endometrial, vulvar, cervical and vaginal)
- Completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
- Post-menopausal as defined by at least one of the following: 12 months (365 days) without a period, bilateral oophorectomy, at least one ovary and hysterectomy, and/or at least one ovary intact and 180 days without a period with FSH
- Must be postmenopausal
- Must have diagnosis of breast cancer or a gynecologic cancer
- Must have completed definitive therapy consisting of surgery, chemotherapy or radiation therapy at least 180 days ago (may continue on Herceptin or endocrine therapy)
- Must have a female sexual function index desire baseline score less than 3.3
Additional criteria may apply.