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Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Primary Purpose

Sickle Cell Anemia, Priapism

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tadalafil
placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Sickle Cell Anemia focused on measuring prolonged, painful erection, priapism, sickle cell anemia

Eligibility Criteria

18 Years - 45 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Tadalafil

Placebo

Arm Description

Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks.

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.

Outcomes

Primary Outcome Measures

change in recurrent priapism frequency
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
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
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
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)

Full Information

First Posted
October 1, 2007
Last Updated
September 20, 2016
Sponsor
Johns Hopkins University
Collaborators
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00538564
Brief Title
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Official Title
Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Trial closed just prior to study receiving Investigational Review Board approval
Study Start Date
November 2006 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Anemia, Priapism
Keywords
prolonged, painful erection, priapism, sickle cell anemia

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tadalafil
Arm Type
Experimental
Arm Description
Participants assigned to this arm were given oral 10 mg tadalafil tablets to take 3 times a week for 16 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
tadalafil
Other Intervention Name(s)
Cialis
Intervention Description
10mg oral tablets taken 3 times a week for 2 months
Intervention Type
Drug
Intervention Name(s)
placebo
Other Intervention Name(s)
sugar pill
Intervention Description
Placebo tablets taken orally 3 times a week for 2 months
Primary Outcome Measure Information:
Title
change in recurrent priapism frequency
Description
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.
Time Frame
From baseline to 2 months post treatment
Title
change of recurrent priapism frequency
Description
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.
Time Frame
From 2 months post treatment to 4 months post treatment
Secondary Outcome Measure Information:
Title
change in nature of sexual experiences
Description
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).
Time Frame
baseline to 2 months post treatment
Title
change in nature of sexual experiences
Description
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)
Time Frame
2 month post treatment to 4 months post treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arthur L. Burnett, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States

12. IPD Sharing Statement

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Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

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