Breast Carcinoma, Cervical Carcinoma, Ovarian Carcinoma, Postmenopausal, Uterine Corpus Cancer, Vaginal Carcinoma, Vulvar Carcinoma
Conditions
Brief 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.
Interventions
By mouth
DRUGPlacebo
By mouth
Sponsors
National Cancer Institute (NCI)
NRG Oncology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PRIOR TO STEP 1 REGISTRATION * Score of \< 9 on the PHQ-4 * Patients must have a FSFI desire subscale baseline score less than 3.3 * NOTE-Both the PHQ-4 and FSFI must be completed by the patient and data entered in Oncology Patient Enrollment Network (OPEN) at Step 1 registration to determine eligibility * Diagnosis of breast or gynecologic cancer \[examples are lobular carcinoma in situ (LCIS),ductal carcinoma in situ (DCIS), invasive breast, ovarian, endometrial, vulvar, cervical and vaginal\] * 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; * Chemically induced menopause as long as there are no plans to stop during the study; * For women 57 and under, if at least one ovary and woman has had hysterectomy, must have follicle stimulating hormone (FSH) (\> 30 mIU/mL) and estradiol in menopausal range per institution?s laboratory (\< 10 for ultra sensitive assay: \< 25-30 otherwise); * At least one ovary intact and 180 days without a period with FSH (\> 30 mIU/mL) and estradiol in menopausal range per institution's laboratory (\< 10 for ultra sensitive assay: \< 25-30 otherwise); Note: Women 58 and older do not have to have hormonal tests. * History, physical and performance status of 2 or less within 180 days prior to registration * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.5 x upper limit of normal (ULN) * Total bilirubin =\< 1.5 x ULN * Glomerular filtration rate \> 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 (\< 7.5 mcg) and it has been used for at least 30 days with no plans to stop or alter use during the course of the study * Antidepressants for mood and hot flashes, including selective serotonin reuptake inhibitors (SSRIs) will be allowed if patients have been on a stable dose for the last 60 days and the dose is not expected to change during the course of the study; only subthreshold or low dose antidepressants will be allowed (e.g. Effexor up to 75 mg or Lexapro 5-10 mg or Celexa 10- 20 mg) * The patient must provide study-specific informed consent prior to study entry/screening * Women who report that their motivation/desire for sexual intimacy has decreased since her cancer diagnosis * Able to swallow whole capsules * Proficient in English (due to number of questionnaires not validated in other languages) * Completion of the FSFI and PHQ-4; both questionnaires will be required and data entered at the time of step 1 registration * PRIOR TO STEP 2 RANDOMIZATION * Completion of the following baseline quality of life forms: PHQ-4, FSFI, PROMIS sexual function and satisfaction, PROMIS fatigue short form 8a, Impact of Treatment Scale, patient reported outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) items, and revised dyadic adjustment scale; these quality of life forms will be required and data must be entered in Medidata Rave at step 2 registration; if available at the time of step 1 registration, step 2 registration can take place immediately after step 1; women who do not currently have a partner do not have to complete the revised dyadic adjustment scale; enter no partner for this form
Exclusion criteria
* Untreated depression, major depressive disorder (MDD), suicidal ideations or anxiety disorders in the past 5 years per the medical chart based on Diagnostic and Statistical Manual (DSM) IV diagnoses * Seizure disorders * Current or history of anorexia or bulimia in the past 5 years * Allergy to bupropion * Use of drugs metabolized by CYP2D6 * Stage IV cancer * History of Parkinson's disease, multiple sclerosis or fibromyalgia * Extensive pelvic exenteration surgery, surgeries which include partial or total vaginectomy with or without reconstruction; radical vulvectomy with or without remove of clitoris * Women who are currently undergoing or planning to undergo reconstruction surgery during the course of the study; women who have completed reconstruction surgery must be 30 days from surgery * Oral or transdermal estrogen therapy is not allowed * Males are not permitted to participate * Patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs after chronic use * Patients who discontinue monoamine oxidase (MAO)-inhibitor (I)'s within 14 days prior to starting the investigational drug * Poorly controlled hypertension (systolic blood pressure \[BP\] \>= 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index (Sexual Desire) | Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization) | The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as sexual desire in the protocol. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline at 5 Weeks in Desire Subscore of the FSFI (Sexual Desire) | Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization) | The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as sexual desire in the protocol. |
| Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction) | Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization) | The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the PROMIS sexual desire and satisfaction measure in the protocol. |
| Change From Baseline in FSFI Total Score (Sexual Functioning) | Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization) | The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as sexual functioning in the protocol. |
| Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood) | Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization) | The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as depressive mood in the protocol. |
| Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score | Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization) | The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue. |
| Perception of Risk vs. Benefit at 9 Weeks | 9 weeks from start of study treatment (within 21 days of randomization) | Participants are asked, Were the benefits of this treatment greater than any side effects? |
| Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study | Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization). | Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data. |
| 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 | 9 weeks from start of study treatment (within 21 days of randomization). | Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much). |
| Global Impression of Change at 9 Weeks (Perception of Change) | 9 weeks from start of study treatment (within 21 days of randomization) | Participants are asked, Since beginning the study agent, my desire of sexual intimacy is: with seven possible answers of very much better, moderately better, a little better, about the same, a little worse, moderately worse, and very much worse. The first three answers have been categorized as Better' and the last three answers as Not Better. This measure is referred to as perception of change in the protocol. |
Countries
United States
Participant flow
Pre-assignment details
Registered patients who completed required baseline assessments were randomized. Of 238 registered patients, 230 were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Bupropion 150 mg One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off). | 79 |
| Bupropion 300 mg One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL PO in a.m. daily for 1 week (titration off) | 74 |
| Placebo One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off) | 77 |
| Total | 230 |
Baseline characteristics
| Characteristic | Bupropion 150 mg | Bupropion 300 mg | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 54.63 years STANDARD_DEVIATION 7.61 | 54.68 years STANDARD_DEVIATION 9.05 | 58.1 years STANDARD_DEVIATION 8 | 55.8 years STANDARD_DEVIATION 8.35 |
| Aromatase Inhibitor therapy No | 44 Participants | 37 Participants | 42 Participants | 123 Participants |
| Aromatase Inhibitor therapy Yes | 35 Participants | 37 Participants | 35 Participants | 107 Participants |
| Current Selective Serotonin Reuptake Inhibitors (SSRI) Use No | 69 Participants | 69 Participants | 66 Participants | 204 Participants |
| Current Selective Serotonin Reuptake Inhibitors (SSRI) Use Yes | 10 Participants | 5 Participants | 11 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 5 Participants | 3 Participants | 11 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants | 69 Participants | 72 Participants | 215 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants | 4 Participants |
| Prior Pelvic Radiation Therapy No | 70 Participants | 72 Participants | 68 Participants | 210 Participants |
| Prior Pelvic Radiation Therapy Yes | 9 Participants | 2 Participants | 9 Participants | 20 Participants |
| Prior Pelvic Surgery No | 56 Participants | 54 Participants | 48 Participants | 158 Participants |
| Prior Pelvic Surgery Yes | 23 Participants | 20 Participants | 29 Participants | 72 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 3 Participants | 5 Participants |
| Race (NIH/OMB) White | 74 Participants | 70 Participants | 67 Participants | 211 Participants |
| Sex: Female, Male Female | 79 Participants | 74 Participants | 77 Participants | 230 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Zubrod 0 | 70 Participants | 70 Participants | 66 Participants | 206 Participants |
| Zubrod 1 | 9 Participants | 4 Participants | 11 Participants | 24 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 79 | 0 / 74 | 0 / 77 |
| other Total, other adverse events | 53 / 77 | 55 / 73 | 57 / 76 |
| serious Total, serious adverse events | 1 / 77 | 0 / 73 | 0 / 76 |
Outcome results
Primary
Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index (Sexual Desire)
The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as sexual desire in the protocol.
Time frame: Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)
Population: Eligible participants with baseline and 9 week data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion 150 mg | Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index (Sexual Desire) | 0.64 units on a scale | Standard Deviation 0.95 |
| Bupropion 300 mg | Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index (Sexual Desire) | 0.60 units on a scale | Standard Deviation 0.89 |
| Placebo | Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index (Sexual Desire) | 0.62 units on a scale | Standard Deviation 1.18 |
Comparison: Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..p-value: 0.46t-test, 1 sided
Comparison: Using a two sample t-test with a one-sided type I error of 0.05 (overall type I error of 0.1 after a Bonferroni correction) and an effect size of 0.45, 62 patients/arm were calculated to be needed to achieve 80% statistical power. Adjusting for 20% non-compliance resulted in a total sample size of 234 patients..p-value: 0.54t-test, 1 sided
Secondary
Change From Baseline at 5 Weeks in Desire Subscore of the FSFI (Sexual Desire)
The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as sexual desire in the protocol.
Time frame: Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization)
Population: Eligible with baseline and 5 week data
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bupropion 150 mg | Change From Baseline at 5 Weeks in Desire Subscore of the FSFI (Sexual Desire) | 0.70 units on a scale | Standard Deviation 0.9 |
| Bupropion 300 mg | Change From Baseline at 5 Weeks in Desire Subscore of the FSFI (Sexual Desire) | 0.48 units on a scale | Standard Deviation 0.69 |
| Placebo | Change From Baseline at 5 Weeks in Desire Subscore of the FSFI (Sexual Desire) | 0.58 units on a scale | Standard Deviation 0.99 |
p-value: 0.24t-test, 1 sided
p-value: 0.74t-test, 1 sided
Secondary
Change From Baseline in FSFI Total Score (Sexual Functioning)
The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as sexual functioning in the protocol.
Time frame: Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
Population: Eligible with baseline data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion 150 mg | Change From Baseline in FSFI Total Score (Sexual Functioning) | Week 5 | 3.84 units on a scale | Standard Error 7.84 |
| Bupropion 150 mg | Change From Baseline in FSFI Total Score (Sexual Functioning) | Week 9 | 3.29 units on a scale | Standard Error 7.66 |
| Bupropion 300 mg | Change From Baseline in FSFI Total Score (Sexual Functioning) | Week 5 | 4.01 units on a scale | Standard Error 6.08 |
| Bupropion 300 mg | Change From Baseline in FSFI Total Score (Sexual Functioning) | Week 9 | 3.55 units on a scale | Standard Error 6.63 |
| Placebo | Change From Baseline in FSFI Total Score (Sexual Functioning) | Week 5 | 3.53 units on a scale | Standard Error 7.48 |
| Placebo | Change From Baseline in FSFI Total Score (Sexual Functioning) | Week 9 | 4.70 units on a scale | Standard Error 8.36 |
Comparison: Week 5p-value: 0.41t-test, 1 sided
Comparison: Week 5p-value: 0.35t-test, 1 sided
Comparison: Week 9p-value: 0.83t-test, 1 sided
Comparison: Week 9p-value: 0.79t-test, 1 sided
Secondary
Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood)
The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as depressive mood in the protocol.
Time frame: Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
Population: Eligible with baseline data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion 150 mg | Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood) | Week 5 | -0.44 units on a scale | Standard Error 1.77 |
| Bupropion 150 mg | Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood) | Week 9 | -0.42 units on a scale | Standard Error 1.68 |
| Bupropion 300 mg | Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood) | Week 5 | -0.17 units on a scale | Standard Error 1.91 |
| Bupropion 300 mg | Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood) | Week 9 | -0.43 units on a scale | Standard Error 1.86 |
| Placebo | Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood) | Week 5 | -0.16 units on a scale | Standard Error 2.29 |
| Placebo | Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score (Depressive Mood) | Week 9 | -0.43 units on a scale | Standard Error 2.39 |
Comparison: Week 5p-value: 0.78t-test, 1 sided
Comparison: Week 5p-value: 0.51t-test, 1 sided
Comparison: Week 9p-value: 0.49t-test, 1 sided
Comparison: Week 9p-value: 0.5t-test, 1 sided
Secondary
Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score
The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.
Time frame: Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
Population: Eligible with baseline data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion 150 mg | Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score | Week 5 | -2.29 units on a scale | Standard Deviation 7.05 |
| Bupropion 150 mg | Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score | Week 9 | -3.28 units on a scale | Standard Deviation 9.46 |
| Bupropion 300 mg | Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score | Week 5 | -1.11 units on a scale | Standard Deviation 7.63 |
| Bupropion 300 mg | Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score | Week 9 | -3.14 units on a scale | Standard Deviation 7.88 |
| Placebo | Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score | Week 5 | -0.30 units on a scale | Standard Deviation 6.71 |
| Placebo | Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score | Week 9 | -3.42 units on a scale | Standard Deviation 6.59 |
Comparison: Week 5p-value: 0.95t-test, 1 sided
Comparison: Week 5p-value: 0.73t-test, 1 sided
Comparison: Week 9p-value: 0.46t-test, 1 sided
Comparison: Week 9p-value: 0.42t-test, 1 sided
Secondary
Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction)
The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the PROMIS sexual desire and satisfaction measure in the protocol.
Time frame: Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
Population: Eligible with baseline data
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Bupropion 150 mg | Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction) | Week 5 | 3.35 units on a scale | Standard Deviation 7.27 |
| Bupropion 150 mg | Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction) | Week 9 | 2.05 units on a scale | Standard Deviation 6.51 |
| Bupropion 300 mg | Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction) | Week 5 | 2.81 units on a scale | Standard Deviation 5.82 |
| Bupropion 300 mg | Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction) | Week 9 | 2.72 units on a scale | Standard Deviation 4.72 |
| Placebo | Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction) | Week 5 | 3.08 units on a scale | Standard Deviation 6 |
| Placebo | Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure (Sexual Desire and Satisfaction) | Week 9 | 3.58 units on a scale | Standard Deviation 6.93 |
Comparison: Week 5p-value: 0.41t-test, 1 sided
Comparison: Week 5p-value: 0.6t-test, 1 sided
Comparison: Week 9p-value: 0.9t-test, 1 sided
Comparison: Week 9p-value: 0.79t-test, 1 sided
Secondary
Global Impression of Change at 9 Weeks (Perception of Change)
Participants are asked, Since beginning the study agent, my desire of sexual intimacy is: with seven possible answers of very much better, moderately better, a little better, about the same, a little worse, moderately worse, and very much worse. The first three answers have been categorized as Better' and the last three answers as Not Better. This measure is referred to as perception of change in the protocol.
Time frame: 9 weeks from start of study treatment (within 21 days of randomization)
Population: Eligible with data
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupropion 150 mg | Global Impression of Change at 9 Weeks (Perception of Change) | Not Better | 43 Participants |
| Bupropion 150 mg | Global Impression of Change at 9 Weeks (Perception of Change) | Better | 23 Participants |
| Bupropion 300 mg | Global Impression of Change at 9 Weeks (Perception of Change) | Not Better | 36 Participants |
| Bupropion 300 mg | Global Impression of Change at 9 Weeks (Perception of Change) | Better | 24 Participants |
| Placebo | Global Impression of Change at 9 Weeks (Perception of Change) | Not Better | 43 Participants |
| Placebo | Global Impression of Change at 9 Weeks (Perception of Change) | Better | 20 Participants |
p-value: 0.71Chi-squared
p-value: 0.34Chi-squared
Secondary
Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study
Common Terminology Criteria for Adverse Events (version 4) grades adverse event severity from 1=mild to 5=death. Summary data is provided in this outcome measure.; see Adverse Events Module for specific adverse event data.
Time frame: Adverse events were evaluated 1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).
Population: Eligible with adverse event data and started study treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Bupropion 150 mg | Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study | 4 Participants |
| Bupropion 300 mg | Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study | 1 Participants |
| Placebo | Number of Participants With a Grade 3 or Higher Adverse Event Over the Course of the Study | 3 Participants |
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
Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).
Time frame: 9 weeks from start of study treatment (within 21 days of randomization).
Population: Eligible with 9 week data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupropion 150 mg | 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 | Severity of insomnia at it's worst = very severe | 0 Participants |
| Bupropion 150 mg | 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 | Frequency of headache = almost constantly | 0 Participants |
| Bupropion 150 mg | 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 | Severity of constipation at its worst = very severe | 0 Participants |
| Bupropion 150 mg | 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 | Interference of decreased appetite with usual or daily activities = very much | 0 Participants |
| Bupropion 150 mg | 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 | Interference of dizziness with usual or daily activities = very much | 0 Participants |
| Bupropion 150 mg | 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 | Severity of dizziness at its worst = very severe | 0 Participants |
| Bupropion 150 mg | 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 | Severity of dry mouth at its worst = very severe | 0 Participants |
| Bupropion 150 mg | 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 | Severity of decreased appetite at its worst= very severe | 0 Participants |
| Bupropion 150 mg | 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 | Interference of headache with usual or daily activities = very much | 0 Participants |
| Bupropion 150 mg | 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 | Frequency of nausea = almost constantly | 1 Participants |
| Bupropion 150 mg | 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 | Interference of insomnia with usual or daily activities = very much | 0 Participants |
| Bupropion 150 mg | 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 | Severity of headache at its worst = very severe | 0 Participants |
| Bupropion 150 mg | 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 | Severity of nausea at its worst = very severe | 0 Participants |
| Bupropion 300 mg | 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 | Severity of dizziness at its worst = very severe | 0 Participants |
| Bupropion 300 mg | 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 | Severity of dry mouth at its worst = very severe | 0 Participants |
| Bupropion 300 mg | 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 | Severity of decreased appetite at its worst= very severe | 0 Participants |
| Bupropion 300 mg | 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 | Interference of decreased appetite with usual or daily activities = very much | 0 Participants |
| Bupropion 300 mg | 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 | Frequency of nausea = almost constantly | 0 Participants |
| Bupropion 300 mg | 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 | Severity of nausea at its worst = very severe | 0 Participants |
| Bupropion 300 mg | 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 | Severity of constipation at its worst = very severe | 0 Participants |
| Bupropion 300 mg | 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 | Interference of dizziness with usual or daily activities = very much | 0 Participants |
| Bupropion 300 mg | 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 | Frequency of headache = almost constantly | 0 Participants |
| Bupropion 300 mg | 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 | Severity of headache at its worst = very severe | 1 Participants |
| Bupropion 300 mg | 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 | Interference of headache with usual or daily activities = very much | 1 Participants |
| Bupropion 300 mg | 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 | Severity of insomnia at it's worst = very severe | 0 Participants |
| Bupropion 300 mg | 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 | Interference of insomnia with usual or daily activities = very much | 0 Participants |
| Placebo | 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 | Frequency of headache = almost constantly | 0 Participants |
| Placebo | 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 | Frequency of nausea = almost constantly | 0 Participants |
| Placebo | 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 | Severity of insomnia at it's worst = very severe | 1 Participants |
| Placebo | 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 | Severity of headache at its worst = very severe | 0 Participants |
| Placebo | 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 | Interference of decreased appetite with usual or daily activities = very much | 0 Participants |
| Placebo | 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 | Severity of dry mouth at its worst = very severe | 0 Participants |
| Placebo | 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 | Interference of headache with usual or daily activities = very much | 0 Participants |
| Placebo | 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 | Severity of dizziness at its worst = very severe | 0 Participants |
| Placebo | 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 | Severity of constipation at its worst = very severe | 0 Participants |
| Placebo | 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 | Severity of decreased appetite at its worst= very severe | 0 Participants |
| Placebo | 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 | Interference of dizziness with usual or daily activities = very much | 0 Participants |
| Placebo | 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 | Severity of nausea at its worst = very severe | 0 Participants |
| Placebo | 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 | Interference of insomnia with usual or daily activities = very much | 1 Participants |
Secondary
Perception of Risk vs. Benefit at 9 Weeks
Participants are asked, Were the benefits of this treatment greater than any side effects?
Time frame: 9 weeks from start of study treatment (within 21 days of randomization)
Population: Eligible with data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Bupropion 150 mg | Perception of Risk vs. Benefit at 9 Weeks | No | 37 Participants |
| Bupropion 150 mg | Perception of Risk vs. Benefit at 9 Weeks | Yes | 30 Participants |
| Bupropion 300 mg | Perception of Risk vs. Benefit at 9 Weeks | No | 32 Participants |
| Bupropion 300 mg | Perception of Risk vs. Benefit at 9 Weeks | Yes | 26 Participants |
| Placebo | Perception of Risk vs. Benefit at 9 Weeks | No | 40 Participants |
| Placebo | Perception of Risk vs. Benefit at 9 Weeks | Yes | 21 Participants |
p-value: 0.23t-test, 1 sided
p-value: 0.25t-test, 1 sided