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Safety and Effectiveness Study of Duloxetine HCl in Women of Different Backgrounds With Stress Urinary Incontinence Who May Also Have Other Various Medical Conditions.

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Lilly

Status and phase

Completed
Phase 4

Conditions

Stress Urinary Incontinence

Treatments

Drug: duloxetine HCl

Study type

Interventional

Funder types

Industry

Identifiers

NCT00190905
8363
F1J-US-SBCD

Details and patient eligibility

About

The purpose of the trial is to study the safety and effectiveness of duloxetine HCl in women of different backgrounds with stress urinary incontinence who may also have other various medical conditions.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women age 18 years or older who have for the 3 months prior to study entry at least 1 episode per week of stress urinary incontinence or stress predominant urinary incontinence defined as twice as many stress as urge urinary incontinence episodes per week.
  • Women of non-childbearing potential by reason of hysterectomy, surgical or natural menopause. Women of childbearing potential should be using a medically accepted means of contraception.
  • Must provide informed consent.
  • Must not have urinary tract infection at screening.

Exclusion criteria

  • Sensitivity to duloxetine
  • Unstable medical conditions
  • Pregnancy
  • Acute liver damage
  • Suicidal in the opinion of the investigator

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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