Trial Outcomes & Findings for Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia (NCT NCT00940901)
NCT ID: NCT00940901
Last Updated: 2017-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
change between baseline and 8 weeks post intervention
Results posted on
2017-04-13
Participant Flow
Participant milestones
| Measure |
Sildenafil
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
|
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.
|
|---|---|---|
|
Weeks 1-8 (Phase 1)
STARTED
|
6
|
7
|
|
Weeks 1-8 (Phase 1)
COMPLETED
|
6
|
7
|
|
Weeks 1-8 (Phase 1)
NOT COMPLETED
|
0
|
0
|
|
Week 9-16 (Phase 2)
STARTED
|
6
|
7
|
|
Week 9-16 (Phase 2)
COMPLETED
|
4
|
4
|
|
Week 9-16 (Phase 2)
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Baseline characteristics by cohort
| Measure |
Sildenafil
n=6 Participants
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks
|
Placebo Then Sildenafil
n=7 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.
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.7 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
23.0 years
STANDARD_DEVIATION 8.7 • n=7 Participants
|
22.5 years
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
7 participants
n=7 Participants
|
13 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: change between baseline and 8 weeks post interventionPopulation: Intention to treat analysis.
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.
Outcome measures
| Measure |
Sildenafil
n=6 Participants
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
|
Placebo Then Sildenafil
n=7 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.
|
|---|---|---|
|
Greater Than or Equal to a 50% Reduction in Priapic Episodes
|
3 Number of participants
|
3 Number of participants
|
PRIMARY outcome
Timeframe: change between 8 weeks post intervention and 16 weeks post interventionPopulation: 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.
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.
Outcome measures
| Measure |
Sildenafil
n=4 Participants
Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
|
Placebo Then Sildenafil
n=4 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.
|
|---|---|---|
|
Greater Than or Equal to a 50% Reduction in Priapic Episodes
|
2 Number of participants
|
3 Number of participants
|
Adverse Events
Sildenafil Phase 1
Serious events: 3 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo Then Sildenafil Phase 1
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Sildenafil Phase 2
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Placebo Then Sildenafil Phase 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Sildenafil Phase 1
n=6 participants at risk
Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
|
Placebo Then Sildenafil Phase 1
n=7 participants at risk
Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
|
Sildenafil Phase 2
n=4 participants at risk
Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
|
Placebo Then Sildenafil Phase 2
n=4 participants at risk
Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Priapism
|
33.3%
2/6 • Number of events 4 • baseline to 16 weeks post intervention
|
14.3%
1/7 • Number of events 1 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
lightheadedness
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
shortness of breath
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
coffee ground emesis
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
emesis
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
epistaxis
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
fever
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
chills
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
back pain
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
chest tightness
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
rhinorrhea
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
cough
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
congestion
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Respiratory, thoracic and mediastinal disorders
asthma attack
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Vascular disorders
Vaso-occlusive Pain crisis
|
16.7%
1/6 • Number of events 2 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Gastrointestinal disorders
Constipation
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Reproductive system and breast disorders
Penile Swelling
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
Low blood count
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
Other adverse events
| Measure |
Sildenafil Phase 1
n=6 participants at risk
Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
|
Placebo Then Sildenafil Phase 1
n=7 participants at risk
Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
|
Sildenafil Phase 2
n=4 participants at risk
Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
|
Placebo Then Sildenafil Phase 2
n=4 participants at risk
Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Priapism
|
50.0%
3/6 • Number of events 3 • baseline to 16 weeks post intervention
|
14.3%
1/7 • Number of events 1 • baseline to 16 weeks post intervention
|
50.0%
2/4 • Number of events 3 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Eye disorders
vision trouble
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
28.6%
2/7 • Number of events 2 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Musculoskeletal and connective tissue disorders
jittery feelings
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Respiratory, thoracic and mediastinal disorders
viral upper respiratory infection/cough/sore throat (cold)
|
50.0%
3/6 • Number of events 4 • baseline to 16 weeks post intervention
|
28.6%
2/7 • Number of events 2 • baseline to 16 weeks post intervention
|
25.0%
1/4 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Gastrointestinal disorders
stomach pain
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Gastrointestinal disorders
constipation
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
low blood count
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
General disorders
elevated temperature
|
16.7%
1/6 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/7 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
|
Blood and lymphatic system disorders
pain crisis
|
0.00%
0/6 • baseline to 16 weeks post intervention
|
14.3%
1/7 • Number of events 1 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
0.00%
0/4 • baseline to 16 weeks post intervention
|
Additional Information
Dr. Arthur L. Burnett, Director of Sexual Medicine Fellowship Program
Johns Hopkins University, School of Medicine
Phone: 410-614-3986
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place