A clinical trial to study the effects of Dapoxetine in premature ejaculation in the adult population.

Phase 3

• Registration Number: CTRI/2010/091/001089
• Lead Sponsor: Sun Pharmaceutical Industries Ltd.Acme Plaza, Andheri Kurla Road, Andheri East,Mumbai ? 400059. Maharashtra. India.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

1.Male patients aged between 21 and 64 years.
2.Patients are in a stable, monogamous sexual relationship with the same woman for at least 6 months and plans to maintain this relationship for the duration of the study.
3.Diagnosis of PE according to the criteria of Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) for at least 6 months before study initiation.
4.Patients with willingness for minimum 2 sexual intercourse in a week.
5.Patients willing to give consent for participation in the study

Exclusion Criteria

1.Patients with erectile dysfunction or other forms of sexual dysfunction and or partner sexual dysfunction.
2.Patients who are using SSRIs or tricyclic antidepressant as concomitant medication.
3.Patients with history of mania, hypomania or bipolar disorder.
4.Patients with uncontrolled hypertension or cardiac impairment.
5.Patients with epilepsy.
6.Patients who are using other forms of therapy for premature ejaculation (pharmacological or behavioral).
7.Patients taken Dapoxetine or participated in another study investigating pharmacologic treatment of PE.
8.Alcoholic patients.
9.Patients with known allergy or hypersensitivity to SSRIs or SNRIs.
10.Patients with history of malignancy.
11.Patients with moderate to severe liver problem.
12.Patients with moderate to severe hepatic impairment.
13.Patients with orthostatic hypotension.
14.Patients whose partners had problems with self-reported female sexual dysfunction.
15.Patients using recreational drugs with serotonergic activity such as ketamine, methylenedioxymethamphetamine (MDMA) and lysergic acid diethylamide (LSD).
16.Patients whose treatment for ongoing depression or anxiety is discontinued, in order to initiate Dapoxetine for the treatment of PE.
17.Patients with bleeding or coagulation disorders.
18.Patients with severe renal impairment.
19.Patients on CNS active medicinal products.
20.Patients taking PDE5 inhibitors like tadalafil and sildenafil.
21.Patients who use alpha adrenergic receptor antagonists.
22Patients taking warfarin chronically.
23.Patients using following medication as concomitant medication or discontinued such medication within 7 days of screening:
?MAOIs, Thioridazine, SSRIs, SNRIs, TCAs, Phenothiazine, acetylsalicylic acid, NSAIDs, antiplatelet agents or anticoagulant (e.g., Warfarin)
?Herbal products with serotonergic effects (e.g. tryptophan, triptans, tramadol, linezolid, lithium, St. John?s Wort (Hypericum perforatum).
?Potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, aquinavir, telithromycin, nefazadone, nelfinavir, atazanavir

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
?Evaluation of average individual PEP score between treatment groups <br>Perceived control over ejaculation<br>Personal distress related to ejaculation<br>Satisfaction with sexual intercourse<br>Interpersonal difficulty related to ejaculation<br>?Evaluation of PEP Index score (Mean of all four measures )<br>Timepoint: Day 0, day 14, and day 35.

Secondary Outcome Measures

Name	Time	Method
1.Patients impression of severity by ??severity?? scale, between treatment groups.<br>2.Patients global impression of change in their condition by ??change?? scale, between treatment groupsTimepoint: 1. Day 0, day 14 and day 35<br>2. Day 14 and day 35