Treatment of Sexual Dysfunction in Men With Epilepsy With Testosterone and Either Arimidex or Placebo - Full Text View

Sponsor:	Beth Israel Deaconess Medical Center
Collaborator:	AstraZeneca
Information provided by:	Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:	NCT00179517

Purpose

The purpose of this study is to determine if treatment using a medication (Arimidex), which lowers estrogen levels in the blood is better than placebo, a tablet that does not contain any active medication, when combined with testosterone replacement to treat reproductive and sexual dysfunction in men with epilepsy. Arimidex, the medication that is currently under study, does not, at this time, have FDA approval for use for this indication.

Condition	Intervention	Phase
Seizure Disorder Hypogonadism Erectile Dysfunction	Drug: Arimidex	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison of Arimidex and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism

Resource links provided by NLM:

Genetics Home Reference related topics: pyridoxal 5'-phosphate-dependent epilepsy pyridoxine-dependent epilepsy

MedlinePlus related topics: Epilepsy Erectile Dysfunction Seizures

Drug Information available for: Testosterone Propionate Methyltestosterone Testosterone Anastrozole Oxymesterone Testosterone enanthate Testosterone undecanoate

U.S. FDA Resources

Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:

The specific purpose of this investigation is to determine if sexual function scores increase more with Arimidex and testosterone treatment than with placebo and testosterone treatment.

Secondary Outcome Measures:

A greater proportion of men will achieve normalization of sexual scores using Arimidex than placebo.
Bioactive testosterone levels will increase more with Arimidex than with placebo.
Estradiol levels will decrease more with Arimidex than with placebo.
Bioactive testosterone/estradiol ratios will be higher with Arimidex than with placebo.
Bioactive testosterone/luteinizing hormone ratios will be higher with Arimidex than placebo.
Estradiol/luteinizing hormone ratios will be lower with Arimidex than placebo.
Changes in sexual scores will correlate inversely with serum estradiol levels and positively with increases in bioactive testosterone/estradiol ratios and possibly bioactive testosterone levels.
Changes in seizure frequency will be more favorable with Arimidex than with placebo.
Changes in energy, mood and anxiety scores will be more favorable with Arimidex than with placebo.

Estimated Enrollment:	40
Study Start Date:	June 2001
Study Completion Date:	April 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Detailed Description:

This is a three-month study where baseline information is collected at the first visit and then each patient is started on treatment with testosterone supplementation and either Arimidex or placebo. Lab tests, seizure frequency, sexual function and mood will be monitored on a monthly basis.

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Subject must be a male between the ages of 18 and 50 years.
Subject must have localization-related epilepsy with complex partial and/or secondary generalized seizures.
Subject will meet criteria for hypogonadism (abnormally low bioactive testosterone levels and abnormally low scores on questionnaires of reproductive and sexual function).
Subject will have had a normal urogenital and rectal/prostate exam during the year prior to entry.
Subject will have had documentation of therapeutic range serum AED levels, a normal CBC, and hepatic enzyme (ALT,AST, alkaline phosphatase) levels that are less than twofold elevated during the 6 months prior to entry.

Exclusion Criteria:

Subject that has taken hormones, major tranquilizers or antidepressants in the three months prior to entry.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179517

Locations

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Beth Israel Deaconess Medical Center

AstraZeneca

Investigators

Principal Investigator:

Andrew Herzog, M.D., M.Sc.

Beth Israel Deaconess Medical Center

More Information

No publications provided

Study ID Numbers:	2001P-000149, IRUSANAS0004
Study First Received:	September 13, 2005
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00179517 History of Changes
Health Authority:	United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:

Seizure
Epilepsy
Testosterone
Hormone

Sexual Dysfunction
Hypogonadism
Men

Additional relevant MeSH terms:

Anastrozole
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Brain Diseases
Hormones
Signs and Symptoms
Sexual Dysfunction, Physiological
Mental Disorders
Therapeutic Uses
Aromatase Inhibitors
Sexual Dysfunctions, Psychological
Antineoplastic Agents, Hormonal

Nervous System Diseases
Seizures
Endocrine System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Methyltestosterone
Genital Diseases, Male
Sexual and Gender Disorders
Pharmacologic Actions
Testosterone 17 beta-cypionate
Anabolic Agents
Testosterone
Hypogonadism
Epilepsy
Neurologic Manifestations

ClinicalTrials.gov processed this record on February 08, 2010