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IRCT20140227016765N5 IRCT 2018-10-26 Tehran University of Medical Sciences Effect of Sildenafil on Endometriosis dysmenorrhea Evaluation of sildenafil on dysmenorhea in patients with endometriosis compared to placebo 2018-06-22 anticipated 40 Complete https://irct.ir/trial/15582 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random allocation list for patients is solely available to the epidemiologist. To hide the random allocation process, 40 card sequences of the treatments will be written accordingly, and then the cards will be placed inside sealed envelopes. On each packet, 10-digit code is written randomly and without any order .This is the patient identification number that only the methodologist will be aware of. When the surgeon announces the eligibility of a patient, the methodologist will provide the surgeon with one of the packets, Blinding description: The surgeon and the patients shouldn't be aware of the type and treatment process they are seeking. Also, the person evaluating the outcomes is the third person who is unaware of the random allocation process and type of treatment. To analyze the data, a statistician who is separate from the study process and is unaware of all the processes will be used. 3 endometriosis. Intervention 1: Intervention group: using daily sildenafil, 100 mg tablet, during 3 days of menstrual cycle. Intervention 2: Control group: using daily placebo tablet, similar to sildenafil, during 3 days of menstrual cycle. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Zahra Tavoli
No.116-West 162 avenue- Tehranpars - Tehran
Tehran Iran (Islamic Republic of) 1653915691 +98 21 7771 5342 ztavoli@tums.ac.ir Tehran University of Medical Sciencers scientific Zahra Tavoli
No 116- East 163- Tehranpars-Tehran
Tehran Iran (Islamic Republic of) 1653915691 +98 21 7771 9922 ztavoli@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) patients with moderate to severe endometriosis suffer from dysmenorrhea, They are between 18 and 45 years old They were diagnosed with ultrasound 18 years 45 years Female People who take nitroglicerine during study People who have used any hormonal medication People with hepatorenal disease People with pelvic pain non relevant to menstural cycle People with pervious MI or CVA People with abnormal blood pressure People with PID People with malignancies People with acute eye problem N80 endometriosis Treatment - Drugs Treatment - Drugs Intervention group: using daily sildenafil, 100 mg tablet, during 3 days of menstrual cycle Control group: using daily placebo tablet, similar to sildenafil, during 3 days of menstrual cycle Pain. Timepoint: Before and 1, 2 and 3 hours after the intervention. Method of measurement: VAS questionnaire. The amount of pain-relieving use during the study. Timepoint: At the end of the study. Method of measurement: questionnaire. Tehran University of Medical Sciences Approved 2018-04-22 Ethics committee of School of Medicine; Tehran University of Medical Sciences School of Medicine- Tehran University of Medical Sciences- 16 Azar St- Keshavarz Blvd-Tehran Tehran Tehran Iran (Islamic Republic of)