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| ID | Type | Description | Link |
|---|---|---|---|
| RFA-HL-06-008 | Other Grant/Funding Number | Interdisciplinary Research Consortium U54 |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor sildenafil has an effect on the frequency of recurrent priapism and the quality of life of males with sickle cell disease (SCD).
The proposed research is designed to investigate the utility of continuous, long-term PDE 5 inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of non-willful, excessive penile erection, in patients with SCD. Although precise prevalence figures are not available, priapism in SCD is highly prevalent and thought to afflict approximately 40% of males, based on available literature. Additionally, the disorder exacts devastating consequences, including erectile tissue necrosis, erectile dysfunction, and psychological distress. Management of this disorder remains challenging because the mechanisms underlying priapism are incompletely understood.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| sildenafil | Experimental | Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks. |
|
| placebo | Placebo Comparator | Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sildenafil | Drug | sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Greater Than or Equal to a 50% Reduction in Priapic Episodes | A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had 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. | change between baseline and 8 weeks post intervention |
| Greater Than or Equal to a 50% Reduction in Priapic Episodes | A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had 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. | change between 8 weeks post intervention and 16 weeks post intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur L. Burnett, MD, MBA | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sildenafil | Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks. |
| FG001 | Placebo Then Sildenafil | Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Weeks 1-8 (Phase 1) |
| |||||||||||||
| Week 9-16 (Phase 2) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sildenafil | Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks |
| BG001 | Placebo Then Sildenafil | Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then sildenafil 50 mg for weeks 9-16. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Greater Than or Equal to a 50% Reduction in Priapic Episodes | A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had 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. | Intention to treat analysis. | Posted | Number | Number of participants | change between baseline and 8 weeks post intervention |
|
baseline to 16 weeks post intervention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sildenafil Phase 1 | Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Priapism | Blood and lymphatic system disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Priapism | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Arthur L. Burnett, Director of Sexual Medicine Fellowship Program | Johns Hopkins University, School of Medicine | 410-614-3986 | aburnett@jhmi.edu |
| 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 |
|---|---|
| D000068677 | Sildenafil Citrate |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D013450 | Sulfones |
| D013457 |
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| placebo | Other | placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2) |
|
| NOT COMPLETED |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
|
|
|
| Primary | Greater Than or Equal to a 50% Reduction in Priapic Episodes | A "Priapism sexual activity log" was administered to participants. In the log, participants were asked to quantify the number of priapic episodes they had 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. | 3 participants from the Phase 1 Sildenafil group were lost to follow up during the second phase; 2 individuals from the Phase 1 Placebo then sildenafil group were lost to follow up during the second phase. | Posted | Number | Number of participants | change between 8 weeks post intervention and 16 weeks post intervention |
|
|
|
|
| 3 |
| 6 |
| 5 |
| 6 |
| EG001 | Placebo Then Sildenafil Phase 1 | Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2 | 1 | 7 | 5 | 7 |
| EG002 | Sildenafil Phase 2 | Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2 | 1 | 4 | 2 | 4 |
| EG003 | Placebo Then Sildenafil Phase 2 | Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2 | 0 | 4 | 0 | 4 |
| lightheadedness | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| shortness of breath | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| coffee ground emesis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| emesis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| epistaxis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| fever | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| chills | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| back pain | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| chest tightness | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| rhinorrhea | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| cough | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| congestion | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| asthma attack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Vaso-occlusive Pain crisis | Vascular disorders | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| Penile Swelling | Reproductive system and breast disorders | Non-systematic Assessment |
|
| Low blood count | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| vision trouble | Eye disorders | Non-systematic Assessment |
|
| jittery feelings | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| viral upper respiratory infection/cough/sore throat (cold) | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| stomach pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| constipation | Gastrointestinal disorders | Non-systematic Assessment |
|
| low blood count | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| elevated temperature | General disorders | Non-systematic Assessment |
|
| pain crisis | Blood and lymphatic system disorders | Non-systematic Assessment |
|
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| 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 |
| Sulfur Compounds |
| D010879 | Piperazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |