Clinical Trials Logo
  1. Home
  2. Other
  3. NCT02593396

Bupropion in Sexual Dysfunction Among Methadone Maintenance Treatment Men

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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02593396
Study type Interventional
Source University of Malaya
Contact
Status Completed
Phase Phase 2
Start date December 2015
Completion date December 2017
View Details
See also
  Status Clinical Trial Phase
Completed NCT02430987 - Low Sexual Desire and Metabolic Syndrome N/A
Completed NCT01432665 - Lybrido for Female Sexual Dysfunction Phase 2
Terminated NCT00551785 - Surveillance Study of Women Taking Intrinsa® Phase 4
Completed NCT03232801 - A Mindfulness-based Intervention for Older Women With Low Sexual Desire N/A
Recruiting NCT04179734 - Role of the Melanocortin-4 Receptor in Hypoactive Sexual Desire Disorder Phase 4
Terminated NCT02770768 - Effects of Flibanserin on the Pre- and Post-menopausal Female Brain N/A
Completed NCT01235754 - Extension Study to Assess Persistence of Benefit of LibiGel for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) Phase 3
Completed NCT03287232 - Prasterone (DHEA) for the Treatment of Hypoactive Sexual Desire Disorder (HSDD) Phase 3
Completed NCT00384046 - Testosterone Therapy in Naturally Menopausal Women With Low Sexual Desire Receiving Transdermal Estrogen Phase 3
Completed NCT00331123 - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido Phase 3
Recruiting NCT04943068 - A Phase 3, Bridging, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial to Evaluate the Efficacy and Safety of Subcutaneously Administered Bremelanotide in Premenopausal Women With Hypoactive Sexual Desire Disorder (With or Without Decreased Arousal) Phase 3
Completed NCT03463707 - BP101 for Adults With Female Sexual Dysfunction Phase 3
Completed NCT01208038 - Testosterone Patch's Effects on the Cardiovascular System and Libido Phase 4
Completed NCT00657501 - Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Surgically Menopausal Women Phase 3
Completed NCT04336891 - Effect of Testosterone Treatment on Clitoral Arteries' Hemodynamic Parameters.
Completed NCT01382719 - Bremelanotide in Premenopausal Women With Female Sexual Arousal Disorder and/or Hypoactive Sexual Desire Disorder Phase 2
Recruiting NCT00916396 - Dehydroepiandrosterone (DHEA) Treatment in Women and Men Experiencing Hypoactive Sexual Desire Disorder N/A
Completed NCT00338312 - Study of Transdermal Testosterone Patches in Naturally Menopausal Women With Low Libido Phase 3
Completed NCT00331214 - Study of Transdermal Testosterone Patches in Surgically Menopausal Women With Low Libido Phase 3
Completed NCT00034021 - Ginkgo Biloba: Antidepressant-Induced Sexual Dysfunction Phase 2