Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00211107
Other study ID # CR006088
Secondary ID
Status Completed
Phase Phase 3
First received September 15, 2005
Last updated May 18, 2011
Start date June 2003
Est. completion date June 2004

Study information

Verified date March 2010
Source Alza Corporation, DE, USA
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary purpose of the study is to demonstrate that dapoxetine can prolong intravaginal ejaculatory latency time (IELT) compared with placebo in men with premature ejaculation (PE).


Description:

One form of male sexual dysfunction is premature ejaculation (PE), which is also referred to as rapid ejaculation (RE). An objective measurement of PE in clinical studies is the intravaginal ejaculatory latency time (IELT). This is a randomized, double-blind study in men with PE. The study consists of 2 phases: pre-randomization phase (a screening visit and a 2-week baseline period); 12-week double-blind treatment phase during which patients will receive dapoxetine at one of two dosages, or placebo, for use on an "as-needed" basis. The total duration of the study is approximately 14 weeks. Patients and their partners are expected to attempt sexual intercourse at least 4 times during the baseline period and at least 6 times each month during the treatment phase. Assessments of effectiveness include the average Intravaginal Ejaculatory Latency time (IELT), as measured by stopwatch, during sexual intercourse for the treatment period (12 weeks); control over ejaculation, satisfaction with sexual intercourse, and severity of symptoms, based on questions asked at monthly intervals through the treatment phase. Safety assessments include the incidence, severity, and type of adverse events throughout treatment (12 weeks), vital sign measurements (pulse and blood pressure) and laboratory tests (hematology, chemistry, urinalysis) at monthly intervals. The study hypothesis is that treatment for 12 weeks with dapoxetine prolongs intravaginal ejaculatory latency time, compared with placebo, in men with PE. Oral tablets of dapoxetine (30 milligrams[mg] or 60mg) taken as needed during 12 weeks of treatment. No more than one dose within a 24-hour period.


Recruitment information / eligibility

Status Completed
Enrollment 1294
Est. completion date June 2004
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Heterosexual male in a stable, monogamous, sexual relationship with a female partner for at least 6 months

- onset of orgasm and ejaculation occurs with minimal sexual stimulation before or shortly after penetration and before the person wishes it

- premature ejaculation (PE) in the majority of intercourse experiences in the 6 months before study initiation

- intravaginal latency ejaculatory time (IELT) of <=2 minutes in at least 3 out of 4 events

- participants with partners of child-bearing potential must consent to use a medically acceptable method of contraception throughout the entire study

- participant's partner must have a negative pregnancy test at time of screening.

Exclusion Criteria:

- History of surgery or injury to the pelvis or spinal cord, chronic inflammation of the prostate or urethra

- taking medications that are contraindicated for participation in the study

- currently using other forms of therapy for treatment of PE (for example, behavioral therapy or medications applied locally)

- previously participated in a drug study involving dapoxetine or in another drug trial within the last month

- taken pimozide, astemizole, or monoamine oxidase inhibitors within 6 months of the start of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Dapoxetine


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Alza Corporation, DE, USA

References & Publications (1)

Pryor JL, Althof SE, Steidle C, Rosen RC, Hellstrom WJ, Shabsigh R, Miloslavsky M, Kell S; Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised contro — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Average intravaginal ejaculatory latency time (IELT), as measured by stopwatch during sexual intercourse, between last 2 visits during the treatment period
Secondary Control over ejaculation, satisfaction with sexual intercourse, and severity of symptom impressions, based on questions asked at start of study and through Week 12; incidence, severity, and type of adverse events throughout study (12 weeks).
See also
  Status Clinical Trial Phase
Completed NCT01021670 - An Observational Study of Men With Premature Ejaculation Who Are Treated With Dapoxetine Hydrochloride or Alternate Care Defined as Any Treatment Other Than Dapoxetine Hydrochloride Phase 4
Completed NCT00210613 - A Study of Withdrawal Effects With Dapoxetine in the Treatment of Premature Ejaculation Phase 3
Completed NCT00219635 - Assessment Of Efficacy and Safety UK-390,957 In Men With Premature Ejaculation Phase 2/Phase 3
Completed NCT00219609 - Assessment Of Safety Of UK-390,957 Phase 2/Phase 3
Terminated NCT02918227 - Exploration of Ejaculation Changing Mechanism After Surgery for Benign Prostatic Hyperplasia N/A
Completed NCT00219583 - Assessment Of Efficacy and Safety Of UK-390,957 In Men With Premature Ejaculation Phase 2/Phase 3
Completed NCT00143117 - Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation Phase 2/Phase 3
Completed NCT01366664 - A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin Phase 1
Completed NCT00211094 - A Study of the Effectiveness and Safety of Dapoxetine in the Treatment of Men With Premature Ejaculation Phase 3
Completed NCT01230762 - An Open-Label Study of the Long-Term Safety of Dapoxetine HCl in the Treatment of Rapid Ejaculation Phase 3