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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-005839-76 | EudraCT Number |
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The purpose of the trial is to assess the effect of tadalafil compared to placebo (inactive comparator) on the urethral - and anal pressure and on urine flow in healthy females. Further, the purpose of the trial is to evaluate the potential for going forward with studies of tadalafil in patients suffering from urine or fecal incontinence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil | Experimental | Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2. |
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| Placebo | Placebo Comparator | Subjects are randomized to either 40 mg tadalafil on study day 1 and placebo on study day 2, or placebo on study day 1 and 40 mg tadalafil on study day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tadalafil 40 MG | Drug | Single dose on study day 1/2 |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Placebo-corrected change in opening urethral pressure after single dose tadalafil | Difference in average urethral opening pressure (UOP) after administration of 40 mg tadalafil (UOP-tadalafil) compared to UOP after placebo (during relaxation). | 2 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation). | Difference in average anal opening pressure (AOP) after administration of 40 mg tadalafil compared to AOP after placebo (during relaxation). | 2-hours post-dose |
| Difference in average UOP-tadalafil and average UOP-placebo during squeezing. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thea Christoffersen | Zelo Phase 1 unit, University Hospital Bispebjerg and Frederiksberg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zelo Phase 1 unit | Copenhagen | 2400 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38456894 | Derived | Christoffersen T, Riis T, Sonne DP, Klarskov N. Single-dose Tadalafil Reduces Opening Urethral Pressure: A Randomized, Double-blind, Placebo-controlled, Crossover Trial in Healthy Women. Int Urogynecol J. 2024 Mar;35(3):723-729. doi: 10.1007/s00192-024-05757-9. Epub 2024 Mar 8. |
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| ID | Term |
|---|---|
| D014550 | Urinary Incontinence, Stress |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D014549 | Urinary Incontinence |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Two-period (AB/BA) crossover study
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The tadalafil tablets and placebo are over-encapsulated in identical hard-gelatin capsules. The over-encapsulation, packaging and labelling is performed by the hospital pharmacy.
| Drug |
Identical to active IMP |
|
| 2-hours post-dose |
| Difference in average AOP-tadalafil and average AOP-placebo during squeezing. | 2-hours post-dose |
| Elastance (opening/closing) during relaxation and squeezing (tadalafil compared to placebo). | 2-hours post-dose |
| Difference in maximum urine flow rate (Qmax) and average urine flow rate (Qave) after tadalafil and placebo administration, respectively. | 2-hours post-dose |
| 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 |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |