Clinical Trial: Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

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 Summary:

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.


Sponsor: Johns Hopkins University

Current Primary Outcome:

  • change in recurrent priapism frequency [ Time Frame: From baseline to 2 months post treatment ]
    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 ]
    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.


Original Primary Outcome: 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 ]

Current Secondary Outcome:

  • change in nature of sexual experiences [ Time Frame: baseline to 2 months post treatment ]
    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 ]
    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)


Original Secondary Outcome: 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 ]

Information By: Johns Hopkins University

Dates:
Date Received: October 1, 2007
Date Started: November 2006
Date Completion:
Last Updated: September 20, 2016
Last Verified: September 2016