Urinary Incontinence, Stress
Conditions
Brief 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.
Interventions
DRUGDuloxetine
DRUGPlacebo
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess efficacy of duloxetine 80 mg/day for 8 weeks in women with stress urinary incontinence (SUI) compared with placebo as measured by percent change in incontinence episode frequency from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the safety of duloxetine with that of placebo in the treatment of SUI based on vital signs, laboratory values, and the occurrence of treatment-emergent adverse events (TEAEs). | — |
| To compare the efficacy of duloxetine with that of placebo as measured by the change in the disease-specific quality of life instrument (I QOL) scores from baseline to endpoint. | — |
| To compare the efficacy of duloxetine with that of placebo in subject perceived improvement in SUI as measured by the Patient's Global Impressions of Improvement (PGI I) questionnaire. | — |
Countries
Taiwan
Outcome results
None listed