Phase 3
Completed N=285
The Asia-Pacific Flexible Dose Study of Dapoxetine and Patient Satisfaction in Premature Ejaculation Therapy
Sexual Dysfunction, Physiological
Source: ClinicalTrials.gov NCT01063881 ↗
Enrolled (actual)
285
Serious AEs
0.7%
Results posted
Oct 2012
Primary outcomePrimary: The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment — 228 Patients
Summary
The purpose of the study is to measure the efficacy of flexible dosing of dapoxetine in a setting similar to routine clinical practice.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment |
228 | — |
| SECONDARY The Patient's Level of Control Over Ejaculation |
120; 22; 132; 57; 20; 77 | — |
| SECONDARY The Patient's Level of Satisfaction With Intercourse |
63; 14; 152; 40; 53; 89 | — |
| SECONDARY The Patient's Level of Personal Distress Related to the Speed of Ejaculation |
2; 66; 32; 89; 32; 66 | — |
| SECONDARY The Patient's Degree of Interpersonal Difficulty Related to the Speed of Ejaculation |
12; 87; 40; 82; 78; 65 | — |
| SECONDARY Patient Responses to Improvement With Their Premature Ejaculation After 12 Weeks of Treatment With Dapoxetine |
0; 0; 4; 25; 94; 101 | — |
| SECONDARY The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Dosage) |
109; 107; 12 | — |
| SECONDARY The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Disease Type) |
95; 133 | — |
| SECONDARY The Number of Patients Who Described Their Premature Ejaculation (PE) as At Least "Slightly Better" in Response to Dapoxetine Treatment (Subgroups by Intravaginal Ejaculation Latency Time [IELT]) |
110; 118 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01063881). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.