Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Last updated: September 20, 2016
Sponsor: Johns Hopkins University
Overall Status: Trial Not Available

Phase

2

Condition

Anemia

Sickle Cell Disease

Bone Marrow Disorder

Treatment

N/A

Clinical Study ID

NCT00538564
NA_00004434
  • Ages 18-45
  • Male

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • All men (18 years of age and older) with actively recurrent ischemic priapism, definedas multiple, self-limited erectile events (characteristically less than 3 hours induration) occurring repeatedly at least twice a week in the absence of sexual interestor desire may be considered for enrollment

  • Able to swallow whole tablets equivalent to capsule size 0

  • Available for protocol-specified visits and procedures

Exclusion

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 ormyocardial 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 calledNAION

  • 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

Study Design

Study Start date:
November 01, 2006
Estimated Completion Date:
August 31, 2009

Study 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.

Connect with a study center

  • Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions

    Baltimore, Maryland 21287
    United States

    Site Not Available

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