Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

This study has been terminated.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00538564
First received: October 1, 2007
Last updated: July 26, 2010
Last verified: September 2007
  Purpose

This research is being done to compare the effect of tadalafil with placebo (an inactive substance that looks like the study drug, but which 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. The study will also look at the effect of tadalafil on pulmonary hypertension (increased blood pressure in the blood vessels supplying the lungs).


Condition Intervention Phase
Sickle Cell Anemia
Priapism
Pulmonary Hypertension
Drug: tadalafil
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • The primary measure will be the determination of priapism frequency. This will be accomplished using routinely administered questionnaires. [ Time Frame: priapism questionnaire administered at baseline and monthly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary measures will be the evaluations of the nature of sexual experiences and quality of life impact of priapism treatment. [ Time Frame: questionnaires administered monthly ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2006
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
tadalafil 10mg taken 3 times a week
Drug: tadalafil
10mg oral tablets taken 3 times a week for 2 months
Other Name: Cialis
Placebo Comparator: B
placebo tablets taken 3 times a week for 2 months
Drug: placebo
Placebo tablets taken orally 3 times a week for 2 months

Detailed Description:

This study will investigate PDE5 inhibitor therapy as a potential treatment using tadalafil for recurrent ischemic priapism. Patients meeting enrollment will be randomized to receive medication or placebo. Tadalafil 10mg or matching placebo oral tablets will be taken 3 times per week. 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 for each patient will be 2 months, which should sufficiently reveal whether priapism episodes have lessened. If improvement occurs in a patient who is identified to be on therapy after 2 months, continued open label treatment will be provided for an additional 2 months. In a patient who is identified not to be on therapy after 2 months, he will be offered therapy as open label treatment for 2 months. The study duration for each patient will not exceed 4 months.

Tests and procedures will include a screening/baseline visit for: consent; medical history; physical examination; clinical laboratory tests; completion of questionnaires; echocardiography and distribution of medication. Bi-weekly telephone calls between monthly office visits will include; clinical assessment, concomitant medication assessment; adverse event assessment; compliance with randomized study medication assessment and resupply of medication as needed.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00538564

Locations
United States, Maryland
Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Johns Hopkins University
Eli Lilly and Company
Investigators
Principal Investigator: Arthur L. Burnett, MD Johns Hopkins University
  More Information

No publications provided

Responsible Party: Arthur L. Burnett, M.D., Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00538564     History of Changes
Other Study ID Numbers: NA_00004434
Study First Received: October 1, 2007
Last Updated: July 26, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins University:
prolonged, painful erection
priapism
sickle cell anemia

Additional relevant MeSH terms:
Anemia
Anemia, Sickle Cell
Hypertension
Hypertension, Pulmonary
Priapism
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Cardiovascular Diseases
Genetic Diseases, Inborn
Genital Diseases, Male
Hematologic Diseases
Hemoglobinopathies
Lung Diseases
Penile Diseases
Respiratory Tract Diseases
Vascular Diseases
Tadalafil
Cardiovascular Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Therapeutic Uses
Urological Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on October 20, 2014