Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

NCT ID: NCT00538564

Last Updated: 2016-09-21

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-08-31

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.

Conditions

Sickle Cell Anemia; Priapism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Tadalafil

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

Group Type: EXPERIMENTAL

tadalafil

Intervention Type: DRUG

10mg oral tablets taken 3 times a week for 2 months

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.

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

Placebo tablets taken orally 3 times a week for 2 months

Interventions

tadalafil

10mg oral tablets taken 3 times a week for 2 months

Intervention Type: DRUG

placebo

Placebo tablets taken orally 3 times a week for 2 months

Intervention Type: DRUG

Other Intervention Names

Cialis; sugar pill

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur L. Burnett, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

NA_00004434

Identifier Type: -

Identifier Source: org_study_id