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IRCT20191211045698N1 IRCT 2020-11-04 Tehran University of Medical Sciences Testosterone gel in Depression Comparing the effect of two dosing regimen of testosterone gel 1%(once daily versus two divided doses) on refractory depression(MDD) in depressed men 2019-02-20 anticipated 38 Complete https://irct.ir/trial/51866 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Sampling has been done through patients referred to psychosomatic ward of Imam Khomeini hospital who met the study's inclusion and exclusion criteria. For randomization we used permuted block randomization technique and patients divided to two groups by using the result of random number generation softwares(such as toolbox), also sampling allocation concealed in sequentially numbered, sealed and opaque envelopes, Blinding description: Participants are unaware of which study group they are in also dosage and frequency the other group Received. In addition, The information will be provided to the data analyzer in groups A and B. 1-2 Depression,Hypogonadism. Intervention 1: first intervention group : Patients receiving 10 g of testosterone 1% gel once a day in addition to previous medications. Intervention 2: Seconde intervention group:Patients receiving 10 g of testosterone 1% gel divided in two dosage in addition to previous medications. Yes - There is a plan to make this available What will be shared: All personal data of the participants after unidentifying the personal individual datas, including the age of the individuals,Testosterone levels and Hamilton score before the intervention and 1 month, 2 months and 3 months after the intervention, Sexual function score before and 3 months after the intervention When: 6 months after the publication of the results To whom: Researchers working in academic and scientific institutions Conditions: Please contact relevant numbers or emails before using the data Where to obtain: 1- Nahid Tavakoli: nahid_tavakoli1373@yahoo.com, 0098 9127972230 2- Niayesh Mohebi: niayesh_mohebbi@yahoo.com, 0098 9121781476 How to obtain: Please contact relevant numbers or emails before using the data Comments:
public Nahid Tavakoli
No. 8, Mahtab Ave., Marzdaran Blvd., Tehran
Tehran Iran (Islamic Republic of) 1461747851 +98 21 4438 5027 nahid_tavakoli1373@yahoo.com Tehran University of Medical Sciences scientific Nahid Tavakoli
No. 8, Mahtab Ave., Marzdran Blvd., Tehran
Tehran Iran (Islamic Republic of) 1461747851 +98 21 4438 5027 nahid_tavakoli1373@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Depression(Hamilton Score =>12) Not responded to a 6-week trial of antidepressant drugs testosterone level less than 350ng/dl 35 years no limit Male Acute phase of psychotic symptoms including hallucinations and delusions Bipolar disorder drug addicted Testosterone level > 350ng/dl Suicide or attempted to suicide in the last 3 months Dementia PSA > 4ng/dl Prostate cancer history Treatment - Drugs Treatment - Drugs first intervention group : Patients receiving 10 g of testosterone 1% gel once a day in addition to previous medications. Seconde intervention group:Patients receiving 10 g of testosterone 1% gel divided in two dosage in addition to previous medications. Depression score in Hamilton questionnaire. Timepoint: before the intervention and 1 month, 2 months and 3 months after the start of testosterone gel. Method of measurement: Hamilton questionnaire. Testosterone level. Timepoint: before the intervention and 1 month, 2 months and 3 months after the start of testosterone gel. Method of measurement: Blood test to measure testosterone level. Sexual function score. Timepoint: Before the intervention and 3 months after taking testosterone gel. Method of measurement: IIEF questionnaire. Tehran University of Medical Sciences Approved 2019-03-05 vice-chancellor in research affairs-Tehran university of medical sciences No. 8, Mahtab Ave., Marzdaran Blve.,Tehran Town Tehran Tehran Iran (Islamic Republic of) Approved 2019-06-02 The Institute of Pharmaceutical Sciences -Tehran University of Medical Sciences No. 8, Mahtab Ave., Marzdaran Blve.,Tehran Town Tehran Tehran Iran (Islamic Republic of)