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Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

This study has been withdrawn prior to enrollment.
(Trial closed just prior to study receiving Investigational Review Board approval)
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00538564
First received: October 1, 2007
Last updated: September 20, 2016
Last verified: September 2016
  Purpose
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.

Condition Intervention Phase
Sickle Cell Anemia
Priapism
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:
  • change in recurrent priapism frequency [ Time Frame: From baseline to 2 months post treatment ] [ Designated as safety issue: No ]
    A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have 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 of recurrent priapism frequency [ Time Frame: From 2 months post treatment to 4 months post treatment ] [ Designated as safety issue: No ]
    A "Priapism sexual activity log" will be administered to participants. In the log, participants will be asked to quantify the number of priapic episodes they have 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.


Secondary Outcome Measures:
  • change in nature of sexual experiences [ Time Frame: baseline to 2 months post treatment ] [ Designated as safety issue: No ]
    The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10).

  • change in nature of sexual experiences [ Time Frame: 2 month post treatment to 4 months post treatment ] [ Designated as safety issue: No ]
    The International Index of Erectile Function (IIEF) will be administered. This is a 15 item questionnaire . The questionnaire measures Erectile Function (scored from 0-30), Intercourse satisfaction (0-15), orgasmic function (0-10), Sexual Desire (2-10) and Overall satisfaction (2-10)


Enrollment: 0
Study Start Date: November 2006
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tadalafil
Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks.
Drug: tadalafil
10mg oral tablets taken 3 times a week for 2 months
Other Name: Cialis
Placebo Comparator: Placebo
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.
Drug: placebo
Placebo tablets taken orally 3 times a week for 2 months
Other Name: sugar pill

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years   (Adult)
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

Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00538564     History of Changes
Other Study ID Numbers: NA_00004434 
Study First Received: October 1, 2007
Last Updated: September 20, 2016
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
Priapism
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn
Penile Diseases
Genital Diseases, Male
Tadalafil
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on December 09, 2016