Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men
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|ClinicalTrials.gov Identifier: NCT02593396|
Recruitment Status : Recruiting
First Posted : November 2, 2015
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Sexual Dysfunctions, Psychological Hypoactive Sexual Desire Disorder Erectile Dysfunctions||Drug: Bupropion hydrochloride sustained-release Drug: placebo||Phase 2|
This is a single-center (University Malaya Medical Centre), randomized, double-Blind, placebo-controlled versus bupropion hydrochloride sustained-releases study trial on 70 men who have methadone emergent sexual dysfunction. Bupropion hydrochloride sustained-release (Wellbutrin SR) 150mg once a day for 7 days then 150mg twice a day for 42 days. Taken orally by the subjects.The total duration of the study is expected to be 24 months. 20months for subject recruitment and 4 months for final subject follow-up.
The primary endpoint is Mean improvement in scores on the Clinical Global Impression Scale adapted for sexual Function (CGI-SF). Secondary endpoints are Change from baseline International Index of Erectile Function (IIEF-15) score. Mean improvement in scores on the sexual desire inventory 2 (SDI2). Other evaluation included: Montgomery-Åsberg Depression Rating Scale (MADRS- Malay version ), Mini International Neuropsychiatric Interview (M.I.N.I), Opiate Treatment Index (OTI), World health organization Quality of Life-Brief Scale (WHOQoL-Brief, Malay version), Malay Version of the Golombok-Rust Inventory of Marital State (Mal-GRIMS) and Rapid urine drug test. Safety evaluation included: Incidence of adverse events. Data will be analyzed using linear mixed-effects model.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Trial Of Bupropion Hydrochloride Sustained-Release In The Treatment Of Sexual Dysfunction In Men On Methadone Maintenance Therapy|
|Study Start Date :||August 2015|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||August 2018|
Placebo Comparator: placebo
Up to 70 eligible patients will be randomly assigned to Bupropion Hydrochloride Sustained-Release or placebo treatment groups in a 1:1 ratio using a computer-generated table of random numbers through the use of the Randomization.com program. Subjects will be randomized to to Bupropion Hydrochloride Sustained-Release 150mg b.d. (n = 35) or placebo b.d (n = 35)
Bupropion hydrochloride sustained-release 150mg BD
Drug: Bupropion hydrochloride sustained-release
Up to 70 eligible patients will be randomly assigned to Bupropion Hydrochloride Sustained-Release or placebo treatment groups in a 1:1 ratio using a computer-generated table of random numbers through the use of the Randomization.com program. Subjects will be randomized to to Bupropion Hydrochloride Sustained-Release 150mg b.d. (n = 35) or placebo b.d (n = 35)The study drug will be repacked in the standard capsules by the research assistant who is not involved in the assessment of the study. The study drug and placebo will be packaged in sets of 11 (1 tablet per day for 3 days, followed by 2 tablets per day for 4 days.) for the first week. Subsequently, the study drug and placebo will be packaged in sets of 14 (2 tablets per day for 7 days.).
Other Name: wellbutrin SR
- Change from baseline in Clinical Global Impression Scale adapted for Sexual Function at (CGI-SF)-at 2,4,6. [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]
- Change From Baseline in International Index of Erectile Function (IIEF) score at Weeks 2, 4 and 6 [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]
- Change from baseline in the individual domain scores: erectile function, orgasmic function, sexual desire, intercourse satisfaction and overall sexual satisfaction, of the IIEF at weeks 2, 4, 6 [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]IIEF includes 5 relevant domains of male sexual function :1/ Orgasmic Function Domain was sum of scores for Questions 9 and 10 from the IIEF. Score range: 0 to 5; total 0 to 10. 2/ Sexual Desire Domain was sum of scores for Questions 11 and 12 from the IIEF. Score range: 1 to 5; total 2 to 10. 3/ EF Domain: sum of scores for Questions 1, 2, 3, 4, 5 & 15 from IIEF. Score range: 0 to 5 (Q1 to Q5), 1 to 5 (Q15); total 1 to 30. .4/.Intercourse Satisfaction Domain: sum of scores for Questions 6, 7 and 8 from IIEF. Score range: 0 to 5; total 0 to 15. 5/Overall Satisfaction Domain was sum of scores for Questions 13 and 14 from the IIEF. Score range: 1 to 5; total 2 to 10. Higher score indicates better outcome in all domain.
- Change from baseline in sexual desire inventory 2 (SDI2) score at weeks 2, 4,6, [ Time Frame: at the baseline, day 14(week 2), day 28(week four) and day 42 (week 6) ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02593396
|Contact: Anne Dr Yee, MPMfirstname.lastname@example.org|
|Contact: Hatim Dr Sulaiman, PHDemail@example.com|
|University Malaya Medical Center||Recruiting|
|Kuala Lumpur, Selangor, Malaysia, 59100|
|Contact: Anne Yee firstname.lastname@example.org|
|Contact: Hatim Sulaiman email@example.com|
|Principal Investigator:||Anne Yee||University Malaya Medical Center|