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IRCT20090304001743N15 IRCT 2020-05-01 Hamedan University of Medical Sciences Influence of modafinil in the treatment of premature ejaculation Influence of modafinil in the treatment of premature ejaculation: a randomized, double-blind, placebo-controlled clinical trial 2020-09-22 anticipated 56 Complete https://irct.ir/trial/47360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 23 red cards and 23 blue cards are placed in a non-transparent packets, Each person picks up a packet, Each color is considered for a group, Blinding description: In this study, placebo, which is precisely in the form of a drug product, is administered randomly to the patients and explained to the patients that he or she may receive a drug or placebo. Therefore, the patient and the clinical caregiver are not aware of the type of product.The other person other than the investigator is responsible for the preparation of the drug and placebo boxes and the researcher is not aware of it. The investigator of the outcome is also unaware of the type of product. N/A Premature ejaculation. Intervention 1: Intervention group: Modafinil tablets 100 mg 4 to 6 hours before intercourse. Intervention 2: Control group: placebo tablets 4 to 6 hours before intercourse. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Mohammad haghighi
Farshchian Hospital,Dibaj street
Hamadan Iran (Islamic Republic of) 65175 +98 81 3827 1066 haghighi@umsha.ac.ir Hamedan University of Medical Sciences scientific mohammad Haghighi
Farshchian Hospital,Dibaj street
Hamadan Iran (Islamic Republic of) 65175 +98 81 3827 1066 haghighi@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Premature ejaculation, based on the criteria of the DSM – 5 Married and having at least 6 months continuous sexual intercourse with a sexual partner Life long premature ejaculation Signed written informed consent 18 years 65 years Male Currently under further treatments for premature ejaculation Erectile dysfunction or other sexual disorders Other psychiatric disorders such as Major depressive disorder bipolar disorders, anxiety disorders, post-traumatic stress disorders, or personality disorders Chronic diseases such as diabetes, hypertension, endocrine system disease F52.4 Premature ejaculation Treatment - Drugs Placebo Intervention group: Modafinil tablets 100 mg 4 to 6 hours before intercourse Control group: placebo tablets 4 to 6 hours before intercourse Premature ejaculation profile score. Timepoint: Before the intervention, 4 weeks after the intervention. Method of measurement: Premature ejaculation profile Questionnaire. Intravaginal ejaculation latency time. Timepoint: Before the intervention,4 weeks s after intervention. Method of measurement: By a stopwatch. Hamedan University of Medical Sciences Approved 2020-04-25 Ethics Committee of Hamadan University of Medical Sciences Fahmideh Bulvar.Mahdieh street Hamadan Hamadan Iran (Islamic Republic of)