A Prospective, Observational Study of Men With Premature Ejaculation Who Are Treated With PRILIGY™ or Alternate Care - PAUSE

• Conditions: premature ejaculation; MedDRA version: 12.0Level: PTClassification code 10036596Term: Premature ejaculation

• Registration Number: EUCTR2009-011309-18-FI
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11-06
• Last Update Posted: 3 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 12000

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified