The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy

NCT01063881 | Completed Phase 3 Results

• 3 other identifiers: CR016561R096769PRE3009PASSION
• Study Type: interventional
• Target: 285
• Locations: 3 countries
• Sites: 13

Brief Summary

The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.

Conditions

Sexual Dysfunction, Physiological

Keywords

Sexual Dysfunction, physiological; R096769; Dapoxetine; Phase 3b; Premature Ejaculation

Outcome Measures

Primary Outcomes (1)

• The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment

  The "Clinical Global Impression of Change" (CGIC), a patient-reported scale was used to assess the patient's improvement with premature ejaculation (PE) since initiating treatment with dapoxetine. Patients were asked: "Compared to the start of the study, would you describe your premature ejaculation (PE) problem as: Much worse, Worse, Slightly worse, No change, Slightly better, Better, or Much better?" The number of patients who described improvement with their PE of at least "slightly better" after 12 weeks of treatment with dapoxetine are provided in the table below.

  Week 12

Secondary Outcomes (8)

• The Patient's Level of Control Over Ejaculation

  Baseline and Week 12

• The Patient's Level of Satisfaction With Intercourse

  Baseline and Week 12

• The Patient's Level of Personal Distress Related to the Speed of Ejaculation

  Baseline and Week 12

• The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation

  Baseline and Week 12

• Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine

  Week 12

Study Arms (1)

Dapoxetine

EXPERIMENTAL

Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity may be increased after 4 weeks to 60mg taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.

Drug: Dapoxetine

Interventions

Dapoxetine DRUG

Starting dose is one 30-mg tablet taken approximately 1-3 hours prior to sexual activity, may be increased after 4 weeks to 60mg, taken for 12 weeks. The maximum recommended dosing frequency is once every 24 hours.

Dapoxetine

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be heterosexual males and in a stable monogamous, sexual relationship with a female partner for at least 6 months
• must score =11 in the Premature Ejaculation Diagnostic Tool (PEDT)
• Must have a self-estimated intravaginal ejaculatory latency time (IELT) of = 2 minutes
• Must have an International Index of Erectile Dysfunction (IIEF) score a total of \> or = to 21 in 6 questions from the IIEF used to assess for the absence of moderate to severe erectile dysfunction (ED)
• Premature ejaculation is not exclusively due to the direct effects of a substance (e.g., withdrawal from opioids)
• Must be in good general health with no clinically significant abnormalities as determined by medical history, physical examination, and clinical lab results
• Must have a blood pressure =180 mmHg systolic and =100 mmHg diastolic at screening and at the baseline visit
• Patient's partner must not be pregnant at screening as pregnancy might affect sexual activity
• Participants and partners must agree to attempt sexual intercourse at least 2 times (with a minimum of 24 hours between each event) during the 2-week baseline period and at least 4 times per month during the remainder of the study.

You may not qualify if:

• History of or current major psychiatric disorder such as mood disorder, anxiety disorder, schizophrenia, mania, suicidal ideation, other psychotic disorder
• History of alcohol abuse and dependence, non-alcohol psychoactive substance use disorder (except for caffeine or nicotine/tobacco)
• Suspected history of illicit or recreational drug use
• Known history of moderate to severe renal impairment

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (13)

Unknown Facility

Malvern, Australia

Location

Unknown Facility

St Leonards, Australia

Location

Unknown Facility

Sydney, Australia

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Jinju, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Wŏnju, South Korea

Location

Unknown Facility

Bangkok, Thailand

Location

Unknown Facility

Chiang Mai, Thailand

Location

MeSH Terms

Conditions

Sexual Dysfunction, Physiological; Premature Ejaculation

Interventions

dapoxetine

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases; Ejaculatory Dysfunction; Genital Diseases, Male; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Limitations and Caveats

"Subgroup by dosage" was categorized based on dose-titration patterns observed during the course of the treatment period. Patients were not randomized to treatment by dosage group, disease type, or Intravaginal Ejaculation Latency Time.

Results Point of Contact

• Title: Sr. Director CDTL, RA CVM Urology
• Organization: Janssen Research & Development, LLC

1 908 704-4648

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: May 22, 2010
• Primary Completion: June 14, 2011
• Study Completion: June 14, 2011
• Last Updated: November 19, 2024
• Results First Posted: October 31, 2012

Record last verified: 2024-10

Locations

KR (8); AU (3); TH (2)