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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-MC-SBAF |
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| Name | Class |
|---|---|
| Boehringer Ingelheim | INDUSTRY |
The study is a comparison of the efficacy and safety of duloxetine and pelvic floor muscle training with that of placebo in patients with moderate to severe stress urinary incontinence
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | |||
| Pelvic Floor Muscle Training (PFMT) | Procedure | |||
| Imitation PFMT | Procedure | |||
| placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of combined duloxetine and PFMT with combined placebo and imitation PFMT in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint. | ||
| Effectiveness of combined duloxetine and PFMT with combined placebo and PFMT for up to 12 weeks in women with SUI as measured by percent change in Incontinence Episode Frequency from baseline to endpoint. |
| Measure | Description | Time Frame |
|---|---|---|
| Incontinence Quality of Life scores from baseline to endpoint. | ||
| Patient Global Impression - Impression at endpoint. | ||
| Symptoms Frequency & Bothersomeness. |
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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 - 5 hours, EST), or speak with your personal physician | Weston | Florida | 33331 |
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| Percent change in weekly continence pad usage (CPAD) from baseline to endpoint. |
| Change in Patient Satisfaction Questionnaires -2 and -4 questionnaire scores from baseline to endpoint. |
| Percent change in daily CPAD from baseline to endpoint. |
| Compare safety of duloxetine with placebo based on vital signs , laboratory values and the occurrence of treatment-emergent adverse events. |
| Compare combined duloxetine and PFMT, combined duloxetine and imitation PFMT, combined placebo with PFMT and combined placebo and imitation PFMTwith respect to efficacy and to safety. |
| Compare the effect of duloxetine and placebo on patient compliance to PFMT and imitation PFMT regimes using a daly patient-generated log of completed contractions. |
| Generate long-term safety data (during open-label extension) on duloxetine in the treatment of women with SUI. |
| United States |
| 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 - 5 hours, EST), or speak with your personal physician | Nieuwegein | 3435 | Netherlands |
| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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