Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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This study has been withdrawn prior to enrollment.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

October 1, 2007
September 20, 2016
November 2006
August 2009   (final data collection date for primary outcome measure)
  • 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.
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 ]
Complete list of historical versions of study NCT00538564 on ClinicalTrials.gov Archive Site
  • 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)
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 ]
Not Provided
Not Provided
 
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Sickle Cell Anemia
  • Priapism
  • Drug: tadalafil
    10mg oral tablets taken 3 times a week for 2 months
    Other Name: Cialis
  • Drug: placebo
    Placebo tablets taken orally 3 times a week for 2 months
    Other Name: sugar pill
  • Experimental: Tadalafil
    Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks.
    Intervention: Drug: tadalafil
  • 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.
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2009
August 2009   (final data collection date for primary outcome measure)

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
Male
18 Years to 45 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00538564
NA_00004434
No
Not Provided
Not Provided
Johns Hopkins University
Johns Hopkins University
Eli Lilly and Company
Principal Investigator: Arthur L. Burnett, MD Johns Hopkins University
Johns Hopkins University
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP