Trial Outcomes & Findings for Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men (NCT NCT02593396)
NCT ID: NCT02593396
Last Updated: 2019-08-01
Results Overview
This scale assesses the changes of the sexual function. Scores range from 1 (normal/very much improved) to 7 (most extreme sexual dysfunction/very much worse). Lower scores indicate better sexual functioning.
COMPLETED
PHASE2
80 participants
assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reported
2019-08-01
Participant Flow
All the male subjects who attended the methadone maintenance clinic from December 2015 to December 2017 in University Malaya Medical Center (UMMC) and University Malaya Center of Addiction Science Studies (UMCAS) were approached.Screening data was reviewed to determine subject eligibility.
This study screened 109 and included 80 (73.4%) male patients who met all inclusion criteria and none of the exclusion criteria.
Participant milestones
| Measure |
Placebo
Placebo BD
|
Active
Bupropion hydrochloride sustained-release 150mg BD
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
At Least Done One Efficacy Assessment
|
36
|
36
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
15
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men
Baseline characteristics by cohort
| Measure |
Placebo
n=40 Participants
Placebo BD
|
Active
n=40 Participants
Bupropion hydrochloride sustained-release 150mg BD
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.50 years
STANDARD_DEVIATION 10.09 • n=5 Participants
|
42.30 years
STANDARD_DEVIATION 9.49 • n=7 Participants
|
42.83 years
STANDARD_DEVIATION 9.68 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Malay
|
34 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Chinese
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Indian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Others
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Malay version of International Index of Erectile Function (Mal-IIEF-15)
|
42.44 units on a scale
STANDARD_DEVIATION 16.43 • n=5 Participants
|
41.80 units on a scale
STANDARD_DEVIATION 19.13 • n=7 Participants
|
42.12 units on a scale
STANDARD_DEVIATION 17.78 • n=5 Participants
|
|
Total Malay version of the SDI-2 (SDI-2-BM)
|
42.87 units on a scale
STANDARD_DEVIATION 15.83 • n=5 Participants
|
42.58 units on a scale
STANDARD_DEVIATION 14.97 • n=7 Participants
|
42.73 units on a scale
STANDARD_DEVIATION 15.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reportedPopulation: Intention-to-treat (ITT) analyses were used for all efficacy variables and included all patients who had been randomized, took at least 1 dose of study trial medication and had at least one efficacy assessment after the baseline visit. There were four patients in each arm did not come for first efficacy assessment, Hence, excluded from analysis.
This scale assesses the changes of the sexual function. Scores range from 1 (normal/very much improved) to 7 (most extreme sexual dysfunction/very much worse). Lower scores indicate better sexual functioning.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo BD
|
Active
n=36 Participants
Bupropion hydrochloride sustained-release 150mg BD
|
|---|---|---|
|
Number of Participants With a Score of ≤2 (Much/Very Much Improved) on the Clinical Global Impression Scale Adapted for Sexual Function (CGI-SF) at Week 6 Between Placebo and Active Group
|
10 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reportedPopulation: Intention-to-treat (ITT) analyses were used for all efficacy variables and included all patients who had been randomized, took at least 1 dose of study trial medication and had at least one efficacy assessment after the baseline visit. There were four patients in each arm did not come for first efficacy assessment, Hence, excluded from analysis.
Mal-IIEF-15 is a 15-item, multi-dimensional self-reporting instrument for the evaluation of male sexual function for the past 4 weeks, consisted of five domains; 1) Erectile Function: sum of items 1, 2, 3, 4, 5 \& 15. Total score range =1-30. 2) Orgasmic Function: sum of items 9 and 10. Total score range = 0 -10. 3) Sexual Desire: sum of items 11 and 12. Total score range = 2 -10. 4) Intercourse Satisfaction : sum of scores for Questions 6, 7 and 8. Total score range = 0 -15. 5) Overall Satisfaction: sum of items 13 and 14.Total score range = 2 -10. Items 1-10 is 6-point Likert-type scale from '0' (= No sexual activity) to '5' (= Almost always or always). Items 11-15 is 5-point Likert-type scale from '1' (= Almost never or never) to '5 '(= 'Almost always or always').The total Mal-IIEF-15 range from 5 (minimum) to 75 (Maximum). Higher score indicates better outcome in all domain.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo BD
|
Active
n=36 Participants
Bupropion hydrochloride sustained-release 150mg BD
|
|---|---|---|
|
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
IIEF total
|
43.81 score on a scale
Standard Deviation 19.86
|
52.53 score on a scale
Standard Deviation 16.14
|
|
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
Mal-IIEF-15, Erectile function domain
|
18.06 score on a scale
Standard Deviation 9.43
|
22.56 score on a scale
Standard Deviation 7.69
|
|
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
Mal-IIEF-15, Orgasmic function domain
|
5.99 score on a scale
Standard Deviation 3.75
|
7.30 score on a scale
Standard Deviation 2.92
|
|
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
Mal-IIEF-15, Sexual desire domain
|
6.04 score on a scale
Standard Deviation 1.97
|
6.77 score on a scale
Standard Deviation 1.91
|
|
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
Mal-IIEF-15, Intercourse satisfaction domain
|
6.46 score on a scale
Standard Deviation 4.18
|
8.78 score on a scale
Standard Deviation 3.77
|
|
Mean Difference of Malay Version of International Index of Erectile Function (Mal-IIEF-15) at Week 6 Between Placebo and Active Group
Mal-IIEF-15, Overall satisfaction domain
|
7.14 score on a scale
Standard Deviation 2.41
|
7.10 score on a scale
Standard Deviation 2.29
|
SECONDARY outcome
Timeframe: Assessed at baseline, day 14(week 2), day 28(week four) and day 42 (week 6), data at day 42 (week 6) reportedPopulation: Intention-to-treat (ITT) analyses were used for all efficacy variables and included all patients who had been randomized, took at least 1 dose of study trial medication and had at least one efficacy assessment after the baseline visit. There were four patients in each arm did not come for first efficacy assessment, Hence, excluded from analysis.
This scale contains 14 items which yield two domain scores: dyadic sexual desire (DSD) and solitary sexual desire (SSD). Items 1,2, 10, 14 are 8-point Likert scale from '0' (= not at all) to '7' (= more than once a day) concerning frequency of desire. Remaining Items are 9-point Likert scale from '0' (= 'no desire') to '8' (= 'strong desire'). DSD has 8 items and SSD has 3 items. The total sores for DSD range from 0 to 62, and SSD, range from 0 to 23. All items are summed up to dictate the total sexual desire (total score = 0 to 112). Higher scores reflect higher sexual desire.
Outcome measures
| Measure |
Placebo
n=36 Participants
Placebo BD
|
Active
n=36 Participants
Bupropion hydrochloride sustained-release 150mg BD
|
|---|---|---|
|
Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups
SDI-2
|
47.36 score on a scale
Standard Deviation 21.09
|
53.53 score on a scale
Standard Deviation 15.88
|
|
Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups
DSD
|
29.99 score on a scale
Standard Deviation 13.44
|
36.08 score on a scale
Standard Deviation 10.17
|
|
Mean Difference of Malay Version of Sexual Desire Inventory 2 (SDI-2) Score at Weeks 6 Between Placebo and Active Groups
SSD
|
6.87 score on a scale
Standard Deviation 5.97
|
7.45 score on a scale
Standard Deviation 4.97
|
Adverse Events
Placebo
Active
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=36 participants at risk
Placebo BD
|
Active
n=36 participants at risk
Bupropion hydrochloride sustained-release 150mg BD
|
|---|---|---|
|
General disorders
Insomnia
|
2.8%
1/36 • Number of events 1 • 6 weeks
patient self-report
|
16.7%
6/36 • Number of events 6 • 6 weeks
patient self-report
|
|
Skin and subcutaneous tissue disorders
skin rash
|
0.00%
0/36 • 6 weeks
patient self-report
|
8.3%
3/36 • Number of events 3 • 6 weeks
patient self-report
|
|
Psychiatric disorders
inability to concentrate
|
0.00%
0/36 • 6 weeks
patient self-report
|
5.6%
2/36 • Number of events 2 • 6 weeks
patient self-report
|
|
Gastrointestinal disorders
constipation
|
5.6%
2/36 • Number of events 2 • 6 weeks
patient self-report
|
5.6%
2/36 • Number of events 2 • 6 weeks
patient self-report
|
|
Gastrointestinal disorders
nausea
|
5.6%
2/36 • Number of events 2 • 6 weeks
patient self-report
|
0.00%
0/36 • 6 weeks
patient self-report
|
|
General disorders
ineffectiveness
|
8.3%
3/36 • Number of events 3 • 6 weeks
patient self-report
|
0.00%
0/36 • 6 weeks
patient self-report
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60