Phase 2
N=230
Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
Breast Carcinoma · Cervical Carcinoma · Ovarian Carcinoma · Postmenopausal · Uterine Corpus Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03180294 ↗Enrolled (actual)
230
Serious AEs
0.4%
Results posted
Mar 2022
Primary outcome: Primary: Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire") — 0.64; 0.60; 0.62 units on a scale — p=0.46
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Bupropion 150 mg XL (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NRG Oncology
- Primary completion
- Feb 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire") |
0.64; 0.60; 0.62 | 0.46 |
| SECONDARY Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score |
-2.29; -1.11; -0.30; -3.28; -3.14; -3.42 | 0.95 |
| SECONDARY Change From Baseline at 5 Weeks in Desire Subscore of the FSFI ("Sexual Desire") |
0.70; 0.48; 0.58 | 0.24 |
| SECONDARY Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction") |
3.35; 2.81; 3.08; 2.05; 2.72; 3.58 | 0.41 |
| SECONDARY Change From Baseline in FSFI Total Score ("Sexual Functioning") |
3.84; 4.01; 3.53; 3.29; 3.55; 4.70 | 0.41 |
| SECONDARY Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood") |
-0.44; -0.17; -0.16; -0.42; -0.43; -0.43 | 0.78 |
| SECONDARY Global Impression of Change at 9 Weeks ("Perception of Change") |
43; 36; 43; 23; 24; 20 | 0.71 |
| SECONDARY Perception of Risk vs. Benefit at 9 Weeks |
37; 32; 40; 30; 26; 21 | 0.23 |
| SECONDARY Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study |
4; 1; 3 | — |
| SECONDARY Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks |
0; 0; 0; 0; 0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- PRIOR TO STEP 1 REGISTRATION
- Score of 30 mIU/mL) and estradiol in menopausal range per institution?s laboratory ( 30 mIU/mL) and estradiol in menopausal range per institution's laboratory ( 90ml/min
- For breast cancer patients only, endocrine therapies are allowed (such as aromatase inhibitors, but not current tamoxifen. Prior tamoxifen is permitted with a 30 day wash out period). )
- Vaginal estrogen is allowed, for all protocol disease sites, if dose equal to or less than that in estring ( = 160 mmHg or diastolic BP >= 100 mmHg) on three or more readings in the past 12 months
- Patients with active bipolar disorder
- Patients with impaired decision making as determined by the treating physician
- Concurrent use of bupropion
- Concomitant invasive malignancy requiring treatment other than non-melanomatous skin cancer.
- Previous or concurrent use of flibanserin.
Data sourced from ClinicalTrials.gov (NCT03180294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.