Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Sickle Cell Anemia Clinical Trial

Official title:

Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00538564
• Other study ID #: NA_00004434
• Status: Withdrawn
• Phase: Phase 2
• First received: October 1, 2007
• Last updated: September 20, 2016
• Start date: November 2006
• Est. completion date: August 2009

Study information

• Verified date: September 2016
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Anemia
• Anemia, Sickle Cell
• Priapism
• Sickle Cell Anemia

Intervention

Drug:
• tadalafil
10mg oral tablets taken 3 times a week for 2 months
• placebo
Placebo tablets taken orally 3 times a week for 2 months

Locations

Country	Name	City	State
United States	Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From baseline to 2 months post treatment	No
Primary	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.	From 2 months post treatment to 4 months post treatment	No
Secondary	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).	baseline to 2 months post treatment	No
Secondary	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)	2 month post treatment to 4 months post treatment	No