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IRCT20140105016087N2 IRCT 2021-04-23 Mazandaran University of Medical Sciences The effect of bupropion on impotence in female MS patients Efficacy and safety evaluation of bupropion on sexual dysfunction in female patients with multiple sclerosis - a double blind randomized clinical trial 2021-04-22 anticipated 64 Complete https://irct.ir/trial/54285 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients who are eligible for the study are divided into two groups A and group B using block permutated randomization. Blocking is usually used to balance the number of samples assigned to each of the studied groups. In this study, quadruple blocks including two people from group A and two people from group B are considered and the selection of blocks is considered. It will be in random numbers, Blinding description: Participants, the principal investigator, the data collector, and those evaluating the outcome are blinded in the study. 2-3 Condition 1: Multiple Sclerosis. Condition 2: Sexual dysfunction. Intervention 1: Intervention group:. Intervention 2: Control group:. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals When: Access period starts 6 months after the results are published To whom: It will be available to researchers working in academic and scientific institutions and to people working in the pharmaceutical industry Conditions: Any analysis of unidentified personal data is allowed. Applicants must apply through formal academic channels. Where to obtain: MS clinic - Booalisina hospital - Pasdaran Bvld. sm.baghbanian@mazums.ac.ir How to obtain: The applicant is required to state his / her purpose of access to the documents by e-mail and, if he / she is to be used in the research work, to inform the proposal and the code of ethics received by e-mail. Comments:
public Seyed Mohammad Baghbanian
Pasdaran Blvd. Booalisina hospital
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3348 sm.baghbanian@mazums.ac.ir Mazandaran University of Medical Sciences scientific Seyed Mohammad Baghbanian
Pasdaran Blvd.
Sari Iran (Islamic Republic of) 4815838477 +98 11 3334 3348 sm.baghbanian@mazums.ac.ir Mazandaran University of Medical Sciences Iran (Islamic Republic of) Adult women over 18 years The duration of MS is more than six months Having sexual activity in the last six months Not known to have an acute mental disorder Husband monogamy 18 years no limit Female Moderate to severe depression with HADS questionnaire (score 11 and above) Consumption of silicotropic drugs and benzodiazepines and SSRIs during the study Known for acute mental disorder Pregnancy or breastfeeding Peripheral problems of the genitourinary system lead to sexual dysfunction Facing severe crises such as the death of loved ones during the last six months Withdrawal from study and incomplete answers to the questionnaires so that more than 20% of the questions in each questionnaire are unanswered. History of seizures History of bulimia and anorexia G35 F52 Multiple sclerosis Sexual dysfunction not due to a substance or known physiological condition Treatment - Drugs Placebo Intervention group: Control group: Intimacy and sexual activity in MSISQ 19 questionnaire. Timepoint: The beginning of the study, the sixth week and the twelfth week. Method of measurement: MSISQ 19 questionnaire. Percentage of people with a depression score of less than 11 on the HADS questionnaire. Timepoint: The beginning of the study. Method of measurement: HADS questionnaire. Multiple Sclerosis Quality Of Life. Timepoint: The beginning of the study-End of study. Method of measurement: (MSQOL-54). Fatigue. Timepoint: The beginning of the study. Method of measurement: The Multidimensional Fatigue Inventory. Sphincter disorders. Timepoint: The beginning of the study. Method of measurement: Sphincter Disorder Questionnaire. Mazandaran University of Medical Sciences Approved 2021-01-24 Ethical committee of Mazandaran University of Medical Sciences Vice chancellor of Booalisina Hospital- Pasdaran Blvd. Sari Mazandaran Iran (Islamic Republic of)