Assessment of Efficacy and Safety of UK-390,957 in Men With Premature Ejaculation

A Phase 2b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Dose Response Study to Assess the Efficacy and Safety of Oral UK-390,957 in Men With Premature Ejaculation

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143117

Enrollment

460

Registered

2005-09-02

Start date

2004-08-31

Completion date

2005-06-30

Last updated

2012-11-07

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

Conditions

Ejaculation

Brief summary

To determine whether UK-390,957 is an effective and safe treatment for premature ejaculation.

Interventions

DRUGUK-390,957

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Premature ejaculation as defined by DSM-IV

Exclusion criteria

* History of erectile dysfunction

Design outcomes

Primary

Measure	Time frame
Assessment of efficacy and safety	—

Secondary

Measure	Time frame
Assessment of Quality of Sexual Life	—

Countries

United States

Outcome results

None listed

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