Efficacy and Safety Stress Urinary Incontinence Study

Lilly

Status and phase

Completed

Phase 3

Conditions

Urinary Incontinence, Stress

Treatments

Drug: Placebo

Drug: Duloxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00475358

6231

F1J-MC-SBBT

Details and patient eligibility

About

Study F1J-MC-SBBT will examine the effect of duloxetine treatment in women with SUI. The inclusion and exclusion criteria of this Phase 3 study will ensure that all subjects have a clinical diagnosis of SUI.

Sex

Female

Ages

20+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Are greater than 20 years of age.
Are female outpatients.
Present with SUI based on the disease diagnostic criteria, average at least one incontinent episode per day on the screening diary, and have had symptoms of SUI for a minimum of 3 months prior to study entry.
Are women of non-childbearing potential by reason of hysterectomy, other surgery, or natural menopause, or are women of childbearing potential who test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a medically accepted means of contraception (for example, intrauterine device [IUD], oral or injectable contraceptives, implant, barrier device, sterilization, abstinence, or sex with a vasectomized male partner) for the duration of the study. Women using oral contraceptives or hormone replacement therapy must have a stable dose and regimen for greater than or equal to 3 months prior to entry into the study.
Have no language barrier, agree to comply with the requirements of the protocol, and sign a written informed consent document prior to entry into the study.

Exclusion criteria

Suffer from severe constipation (for example, have impacted rectum at time of physical examination despite recent evacuation).
Has a physical examination, neurological and/or vaginal examination results which, in the opinion of the investigator, should exclude the subject.
Are on a medication regimen (including diuretics) for which dose and/or frequency has not been stable for at least 12 weeks prior to randomization, or is anticipated to change during the course of the study.
Have had any major inpatient surgery within 3 months prior to study entry.
Have current diagnosis of any of the following conditions, disorders, or diseases of the genito-urinary tract: Ureteric, bladder, urethral, or rectal fistula
Uncorrected congenital abnormality leading to urinary incontinence
Detrusor instability or noncompliant bladder
Adult enuresis
Voiding difficulty (i.e., subject complains of difficulty emptying their bladder).