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Trial closed just prior to study receiving Investigational Review Board approval
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This research is being done to compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but should have no effect) on the frequency of recurrent priapism (prolonged erection, unassociated with sexual interest or desire) and the nature of sexual experiences in male patients with sickle cell disease.
This study will investigate phosphodiesterase 5 (PDE 5) inhibitor therapy as a potential treatment for recurrent ischemic priapism. Enrolled participants will be randomized to receive oral 10 mg tadalafil tablets 3 times a week or receive matching placebo. Patients will be instructed to use the medication in the morning a few hours after awakening from night time sleep, and they will be instructed against engaging in any form of sexual activity or excitement within 8 hours of dosing. Treatment duration will be 2 months for each participant. After the 2 month period, participants on tadalafil and placebo will be offered tadalafil (same dosing regimen) for an additional 2 months.
The study duration will be 4 months.
Tests and procedures will include: consent; medical history; physical examination; clinical laboratory tests; completion of questionnaires; and medication dispensation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tadalafil | Experimental | Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks. |
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| Placebo | Placebo Comparator | Participants assigned to this arm were given a placebo pill 3 times a week for the first 8 weeks, and then Tadalafil 10 mg 3 times a week for weeks 9-16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tadalafil | Drug | 10mg oral tablets taken 3 times a week for 2 months |
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| Measure | Description | Time Frame |
|---|---|---|
| change in recurrent priapism frequency | A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes. | From baseline to 2 months post treatment |
| change of recurrent priapism frequency | A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have experienced in the previous 2 weeks according to the following scale/tiers: 0 = no episodes, 1 = 1-2 episodes, 2 = 3-4 episodes, 3 = 5-8 episodes and 6 = greater than 20 episodes. | From 2 months post treatment to 4 months post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| change in nature of sexual experiences | The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10). | baseline to 2 months post treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur L. Burnett, MD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D000755 | Anemia, Sickle Cell |
| D011317 | Priapism |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D000068581 | Tadalafil |
| D000073893 | Sugars |
| ID | Term |
|---|---|
| D002243 | Carbolines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| placebo | Drug | Placebo tablets taken orally 3 times a week for 2 months |
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|
| change in nature of sexual experiences | The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10) | 2 month post treatment to 4 months post treatment |
| D006425 |
| Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010409 | Penile Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D026121 |
| Indole Alkaloids |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D002241 | Carbohydrates |