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IRCT20221120056553N2 IRCT 2023-02-03 Shahid Beheshti University of Medical Sciences Metformin in Erectile Dysfunction of Diabetic Men The Effect of Metformin on Erectile Dysfunction in Male Patients with Type 2 Diabetes Mellitus 2020-12-21 anticipated 270 Complete https://irct.ir/trial/67323 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random sequence generation will be done by simple randomization and preparing and shuffling cards, so that 270 cards (135 cards with the symbol A and 135 cards with the symbol B) will be prepared and will be placed inside Sequentially Numbered Opaque Sealed Envelops (SNOSE) and will been shuffled. According to arrival eligible patients will choose an envelope, so that the relevant group is determined (patients will be unaware of each other's assigned group). The selected envelope will be separated from the rest of the envelopes. This process will be continued until the 270th patient, so that finally 135 patients will be placed in the intervention group and 135 patients in the placebo group, Blinding description: In this study, patients, clinical caregivers and doctors, the main researcher and the outcome assessor will be unaware of the type of medication the patient is taking (Metformin or placebo) and the medication will be delivered to the patient by a nurse. 3 Condition 1: Type 2 Diabetes Mellitus. Condition 2: Erectile Dysfunction. Condition 3: Erectile Dysfunction. Intervention 1: Intervention group: Patients in this group are prescribed 500 mg metformin tablets, one daily for 3 months. According to the duration of the study, 90 tablets are prepared for each person. Patients will be advised to take the medicine with food to reduce digestive side effects. Intervention 2: Control group: The patients of this group will be given a placebo pill containing oral maltodextrin, one daily for three months. Placebo is completely similar to Metformin in the shape and size of the package. According to the duration of the study, 90 tablets are prepared for each person. Yes - There is a plan to make this available What will be shared: The data spss file includes groups and main and demographic variables When: After publication the article extracted from the plan To whom: Those who have corresponded with the author responsible for the plan and have enough reason to receive the file Conditions: We have not made a decision on this matter and a decision will be made after reviewing the request Where to obtain: Endocrine and metabolic disease research center of Loghman -e Hakim hospital ,Shahid Beheshti medical science , Tehran Saeid Kalbasi email:saeidkalbasi@bums.ac.ir How to obtain: The applicant should send her/him request via email and after obtaining permission from all project partners, if the partners agree with her request, the data will be sent to her/him. Comments:
public Hooriyeh Talati
Yaman Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 5102 5582 hoota_69734@yahoo.com Shahid Beheshti University of Medical Sciences scientific Saeid Kalbasi
Yaman Ave
Tehran Iran (Islamic Republic of) 1985717443 +98 21 5102 5582 Saeidkalbasi@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Men between 30 and 70 years of age who have recently been diagnosed with type 2 diabetes during a visit to the Loqman Hakim Hospital clinic Patients whose HbA1c levels were between 6.5 and 8 in the last six months 30 years 70 years Male Patients with a history of diabetes or those who are being treated with blood sugar control drugs Patients who have anatomical disorders in the penis or other sexual disorders Patients with spinal cord injuries Patients who have a stroke Patients who experienced cardiac attack in the past six months Patients who are being treated with mineral nitrates Patients who have peptic ulcers Patients who have migraine Patients who have visual impairment Patients who have allergic rhinitis E08 N52 F52.21 Diabetes mellitus due to underlying condition Male erectile dysfunction Male erectile disorder Treatment - Drugs Placebo Intervention group: Patients in this group are prescribed 500 mg metformin tablets, one daily for 3 months. According to the duration of the study, 90 tablets are prepared for each person. Patients will be advised to take the medicine with food to reduce digestive side effects. Control group: The patients of this group will be given a placebo pill containing oral maltodextrin, one daily for three months. Placebo is completely similar to Metformin in the shape and size of the package. According to the duration of the study, 90 tablets are prepared for each person. Status of erectile dysfunction. Timepoint: Before the study and 90 days after the intervention. Method of measurement: The International Index of Erectile Function questionnaire. Body weight. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Body weight scale. Body mass index. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Calculator. Systolic blood pressure. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Mercury pressure gauge. Diastolic blood pressure. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Mercury pressure gauge. Glycated hemoglobin A1c. Timepoint: Before the study and 90 days after the intervention. Method of measurement: Chromatography. Fasting Blood Sugar. Timepoint: Before the study and 90 days after intervention. Method of measurement: Photometric method auto analyzer. Testosterone Serum Level. Timepoint: Before the study and 90 days after the intervention. Method of measurement: ELISA Kit. Luteinizing hormone Serum Level. Timepoint: Before the study and 90 days after the intervention. Method of measurement: ELISA Kit. Follicle-Stimulating Hormone Serum Level. Timepoint: Before the study and 90 days after the intervention. Method of measurement: ELISA Kit. Shahid Beheshti University of Medical Sciences Approved 2020-12-15 Ethics committee of Shahid Beheshti of Medical Sciences Yaman Ave Tehran Tehran Iran (Islamic Republic of)