Assessment Of Safety Of UK-390,957

A Phase 2 Multi-Center, Open Label Long-Term Extension Trial To Assess The Safety Of Oral Uk-390,957 Administered As Required In Adult Men With Premature Ejaculation

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00219609

Enrollment

1058

Registered

2005-09-22

Start date

2005-01-31

Completion date

2006-03-31

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 a safe treatment for premature ejaculation.

Interventions

DRUGUK-390,957

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subjects will have completed one of the phase 2 trials (A3871022/ A3871027/ A3871029) and will have met the diagnostic criteria for premature ejaculation as defined by DSM-IV

Exclusion criteria

* No drug related serious adverse events

Design outcomes

Primary

Measure	Time frame
Assessment of safety	—

Countries

Australia, Austria, Canada, Czechia, France, Germany, Israel, Italy, Norway, Poland, Sweden, Turkey (Türkiye), United Kingdom, United States

Outcome results

None listed

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