Hypoactive Sexual Desire Disorder Clinical Trial
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
The purpose of this study is to assess the tolerability, safety, and efficacy of bupropion hydrochloride sustained-release in the treatment of sexual dysfunction in men on methadone maintenance therapy.
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.
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