At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 230 enrolled
Drug / intervention
Bupropion 150 mg XL +1 moredrug
Likely dose
Bupropion 150 mg XL orally once dailyAI-extracted
Key inclusion· 8
- ✓Diagnosis of breast or gynecologic cancer (LCIS, DCIS, invasive breast, ovarian, endometrial, vulvar, cervical, vaginal)
- ✓Completed definitive therapy (surgery, chemotherapy, radiation) ≥180 days ago; may continue Herceptin or endocrine therapy
- ✓Postmenopausal status (≥12 months amenorrhea, bilateral oophorectomy, chemically induced menopause, or FSH >30 mIU/mL with menopausal estradiol)
- ✓FSFI desire subscale baseline score <3.3
Key exclusion· 14
- ✕Untreated depression, major depressive disorder, suicidal ideations, or anxiety disorders in past 5 years
- ✕Seizure disorders
- ✕Current or history of anorexia or bulimia in past 5 years
- ✕Allergy to bupropion
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II Double Blind Dose Finding Trial of Bupropion Versus Placebo for Sexual Desire in Women With Breast or Gynecologic Cancer
In Brief
A Phase 2 clinical trial evaluating Bupropion 150 mg XL and Placebo for Breast Carcinoma and 6 related conditions. Completed, enrolled 230 participants across 362 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Carcinoma, Cervical Carcinoma, Ovarian Carcinoma, Postmenopausal, Uterine Corpus Cancer, Vaginal Carcinoma, Vulvar Carcinoma
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)
Timeline
Phase 2CompletedFinished
201820192020202120222023202420252026
Enrollment StartMay 2017
First PostedJun 2017
Primary CompletionFeb 2021
TodayJul 2026
First PostedJun 8, 2017
Enrollment StartMay 31, 2017
Primary CompletionFeb 22, 2021
TodayJul 2, 2026
Enrollment to primary: 3.7 yearsPosted 9.1 years ago
Interventions
Bupropion 150 mg XLdrug
By mouth
Placebodrug
By mouth