Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Sponsors
Source
Johns Hopkins University
Oversight Info
Has Dmc
No
Brief Summary
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.
Detailed Description
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.
Overall Status
Withdrawn
Start Date
2006-11-01
Completion Date
2009-08-01
Primary Completion Date
2009-08-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
change in recurrent priapism frequency |
From baseline to 2 months post treatment |
|
change of recurrent priapism frequency |
From 2 months post treatment to 4 months post treatment |
Secondary Outcome
Measure |
Time Frame |
|
change in nature of sexual experiences |
baseline to 2 months post treatment |
|
change in nature of sexual experiences |
2 month post treatment to 4 months post treatment |
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
10mg oral tablets taken 3 times a week for 2 months
Arm Group Label
Tadalafil
Other Name
Cialis
Intervention Type
Drug
Intervention Name
Description
Placebo tablets taken orally 3 times a week for 2 months
Arm Group Label
Placebo
Other Name
sugar pill
Eligibility
Criteria
Inclusion Criteria:
- All men (18 years of age and older) with actively recurrent ischemic priapism, defined
as multiple, self-limited erectile events (characteristically less than 3 hours in
duration) occurring repeatedly at least twice a week in the absence of sexual interest
or desire may be considered for enrollment
- Able to swallow whole tablets equivalent to capsule size 0
- Available for protocol-specified visits and procedures
Exclusion Criteria:
- History of refractory-type priapism
- History of drug or alcohol abuse
- Currently smokes or has a 20 pack-year history of cigarette smoking
- Take any medications called "nitrates"
- History of acute or chronic depression
- History of heart problems such as angina, heart failure, irregular heartbeats or
myocardial infarction
- History of low blood pressure or high blood pressure that is not controlled
- History of diabetes, liver problems, or kidney problems
- A glomerular filtration rate of <50ml/min.
- History of retinitis pigmentosa or severe vision loss, including a condition called
NAION
- History of stomach ulcers
- History of HIV, multiple myeloma, or leukemia
- History of Peyronie's disease
- History of spinal trauma or surgery to the brain or spinal cord
- Any contraindications to Cialis use
- Currently participating in another clinical investigation
Gender
Male
Minimum Age
18 Years
Maximum Age
45 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Arthur L. Burnett, MD |
Principal Investigator |
Johns Hopkins University |
Location
Facility |
|
Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions Baltimore Maryland 21287 United States |
Location Countries
Country
United States
Verification Date
2016-09-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Tadalafil
Arm Group
Arm Group Label
Tadalafil
Arm Group Type
Experimental
Description
Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks.
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Description
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.
Firstreceived Results Date
N/A
Why Stopped
Trial closed just prior to study receiving Investigational Review Board approval
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Double (Participant, Investigator)
Study First Submitted
October 1, 2007
Study First Submitted Qc
October 1, 2007
Study First Posted
October 2, 2007
Last Update Submitted
September 20, 2016
Last Update Submitted Qc
September 20, 2016
Last Update Posted
September 21, 2016
ClinicalTrials.gov processed this data on August 27, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.