Tadalafil for Treatment of Priapism in Men With Sickle Cell Anemia

NCT00538564 | Withdrawn Phase 2

• 1 other identifier: NA_00004434
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Sickle Cell Anemia; Priapism

Keywords

prolonged, painful erection; priapism; sickle cell anemia

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (2)

• change in nature of sexual experiences

  baseline to 2 months post treatment

• change in nature of sexual experiences

  2 month post treatment to 4 months post treatment

Study Arms (2)

Tadalafil

EXPERIMENTAL

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

Drug: tadalafil

Placebo

PLACEBO COMPARATOR

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.

Drug: placebo

Interventions

tadalafil DRUG

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

Also known as: Cialis

Tadalafil

placebo DRUG

Placebo tablets taken orally 3 times a week for 2 months

Also known as: sugar pill

Placebo

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• Eli Lilly and Company: collaborator

Study Sites (1)

Johns Hopkins Outpatient Center; Johns Hopkins Medical Institutions

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Anemia, Sickle Cell; Priapism

Interventions

Tadalafil; Sugars

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Penile Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Carbohydrates

Study Officials

• Arthur L. Burnett, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: November 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 21, 2016

Record last verified: 2016-09

Locations

US (1)