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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-SBAB |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
Double-blind placebo-controlled study of the biomechanical effects of duloxetine compared with placebo in the treatment of women with pure genuine stress incontinence
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duloxetine | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effects of duloxetine with placebo in women with urodynamically proved genuine stress incontinence(GSI)on vesical Valsalva leak point pressure |
| Measure | Description | Time Frame |
|---|---|---|
| Compare the effects of duloxetine with that of placebo on measures of bladder emptying phase function derived from | ||
| non-instrumented and instrumented uroflowmetry studies | ||
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Call 1-877-CTLILLY(1-877-285-4559) or 1-317-615-4559 Mon -Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Monday - Friday from 9:00 AM to 5:00 PM Eastern Time (UTC/GMT - 5hours, EST), or speak with your personal physician | Indianapolis | Indiana | 46202 |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Percent change in Incontinent Episode Frequency (IEF) from baseline to endpoint |
| Subject-perceived improvement in their GSI as measured by the Patient Global Impressions-Improvement (PGI-I) questionnaire at endpoint |
| Compare duloxetine responders with duloxetine non-responders with respect to: |
| Baseline measures of urethral function |
| Outcome measures of urethral function |
| Outcome measures of emptying function |
| Vital signs, laboratory values and the occurrence of treatment-emergent adverse events |
| In the open-label extension: |
| Determine the effects of duloxetine six to seven months after initiation on measures of urethral function |
| Collect long-term data on the maintenance of effect of duloxetine in the treatment of GSI as measured by IEF, PGI-I, vital signs, laboratory values and the occurrence of treatment-emergent adverse events. |
| United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |