Overview

Efficacy and Safety Stress Urinary Incontinence Study

Status:
Completed
Trial end date:
2005-02-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Duloxetine Hydrochloride
Criteria
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).