The efficacy and safety of Clomipramine Hydrochloride versus Dapoxetine Hydrochloride in Married Heterosexual Men with Premature Ejaculation: A Pragmatic, Randomized Controlled Trial.

Christian Medical College0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•Married male
•Has active and stable sexual relationship with wife
•Age â?? 21 to 64 years
•Meets DSM-5 criteria for premature ejaculation after screening
•Heterosexual orientation
•Speaks either of these languages â?? Hindi, Bengali, English, Tamil, Telugu, Malayalam
•Agrees to have sexual intercourse at least once a week (or at least six times) over the study period
•Agrees not to use study medicines more than once a day

•Comorbid major mental illness (Psychosis, Bipolar affective disorder, Major Depressive Disorder, Obsessive compulsive disorder);
•Active psychoactive substance use in dependence pattern (other than Nicotine);
•Uncontrolled or Untreated medical comorbidities (Diabetes, Hypertension, Hypothyroidism, Cardiac illness, renal disease);
•Current use of antipsychotic and antidepressant drugs, herbal medicines, phosphodiesterase type 5 inhibitors (for example, sildenafil);
•Use of either Dapoxetine or Clomipramine in the past;
•Any potential neurological, urological, or endocrine cause of PE;
•Scoring 3 or 4 on first two domains, 0 or 1 on the third domain, and 0 on the fourth domain of the Premature Ejaculation Profile (PEP);

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