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| ID | Type | Description | Link |
|---|---|---|---|
| 2005_045 |
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Overactive bladder is very prevalent in postmenopausal women. The current study is designed to investigate whether a new drug may offer safe and effective treatment.
Clinical development of MK-0634 was discontinued. Study MK-0634-027 was a safety follow-up study to determine if there were any ocular effects of MK-0634 in participants from the United Kingdom who were exposed to MK-0634 during the 007 study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MK-0634 50 mg | Experimental | All participants will receive placebo for the 1 week prior to randomization |
|
| MK-0634 125 mg | Experimental | All participants will receive placebo for the 1 week prior to randomization |
|
| MK-0634 375 mg | Experimental | All participants will receive placebo for the 1 week prior to randomization |
|
| Placebo | Placebo Comparator | All participants will receive placebo for the 1 week prior to randomization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MK-0634 50 mg | Drug | one capsule orally, once daily in morning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of micturitions per day averaged over a diary card week (4 to 10 days) | Baseline and Week 8 | |
| Proportion of participants with abnormal retinal photography (Follow-up Study 007 only) | Day 1 of Follow-up | |
| Proportion of participants with abnormal visual field test (Follow-up Study 007 only) | Day 1 of Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the number of total incontinence episodes | Baseline and Week 8 | |
| Number of urge-incontinence episodes | Up to 8 weeks | |
| Number of urgency episodes per day averaged over a diary card week (4 to 10 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Monitor | Merck Sharp & Dohme LLC | Study Director |
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| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| MK-0634 125 mg | Drug | one or three capsules orally, once daily in morning |
|
|
| Placebo for MK-0634 | Drug | one, two, three or four capsules orally once daily in morning |
|
| up to 8 weeks |
| 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 |