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Exploratory Study of Pagoclone in Men With Premature Ejaculation.

A Four-arm, Randomized, Double-blind, Parallel, Placebo-controlled Exploratory Study of Pagoclone 0.15mg, 0.30mg, and 0.60mg in Men With Primary Premature Ejaculation.

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00370981
Enrollment
100
Registered
2006-09-01
Start date
2006-07-31
Completion date
2006-10-31
Last updated
2013-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Premature Ejaculation

Keywords

investigational drug, ejaculation

Brief summary

The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.

Detailed description

The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time (IELT) male patients with primary premature ejaculation.

Interventions

Sponsors

Endo Pharmaceuticals
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* A male regularly experiencing premature ejaculation * 18 to 55 yrs old * In a Stable relationship with one woman for at least 6 months

Design outcomes

Primary

MeasureTime frame
Intravaginal ejaculation latency time (IELT)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026