premature ejaculation MedDRA version: 12.0 Level: PT Classification code 10036596 Term: Premature ejaculation
Conditions
Interventions
Trade Name: Priligy
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Dapoxetine Hydrochloride
CAS Number: 119356773
Current Sponsor code: R096769
Concentration unit: mg milligram(s)
Concen
Sponsors
Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: All patients who present spontaneously to the practice for an evaluation of premature ejaculation, or who have a diagnosis of premature ejaculation and are currently being treated will be considered as candidates for enrollment. There will be no protocol-specific selection criteria other than the guidance provided by the Summary of Product Characteristics for PRILIGY as it is intended that the participating health care provider will use the Summary of Product Characteristics for PRILIGY as a guide to identify appropriate patients for the study (Section 4.1 of the Summary of Product Characteristics, Therapeutic indication) and the types of patients who should use caution or avoid using PRILIGY (Section 4.3 of the Summary of Product Characteristics, Contraindications and Section 4.4 of the Summary of Product Characteristics, Special warnings and precautions for use). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: There will be no protocol-specific exclusion criteria other than the guidance provided by the Summary of Product Characteristics for PRILIGY as it is intended that the participating health care provider will use the Summary of Product Characteristics for PRILIGY as a guide to identify appropriate patients for the study (Section 4.1 of the Summary of Product Characteristics, Therapeutic indication) and the types of patients who should use caution or avoid using PRILIGY (Section 4.3 of the Summary of Product Characteristics, Contraindications and Section 4.4 of the Summary of Product Characteristics, Special warnings and precautions for use).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to characterize the safety profile of PRILIGY when used in clinical practice to treat patients with premature ejaculation.;Secondary Objective: - To identify the proportion of patients who are selected to receive PRILIGY who report a history of an orthostatic reaction and/or have a positive orthostatic test - To study the patterns of PRILIGY use (eg, discontinuation rate, dosage change, - To describe the characteristics of patients in the PRILIGY and alternate care/ non-PRILIGY groups in relation to relevant PRILIGY labeling (ie, precautions, contraindications, or concomitant therapies) - To study the pattern and safety profile of alternate care/non-PRILIGY treatment(s) used to treat patients with premature ejaculation in clinical practice - To gain input from patients and participating health care providers on the understandability and helpfulness of the PRILIGY Patient Information Leaflet and/or Patient Brochure;Primary end point(s): safety profile of Priligy when used in clinical practice | — |
Countries
Finland
Outcome results
None listed