Treatment of Sexual Dysfunction in Men With Epilepsy With Testosterone and Either Arimidex or Placebo

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179517
First received: September 13, 2005
Last updated: May 5, 2008
Last verified: October 2007
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

ClinicalTrials.gov Identifier: NCT00179517     History of Changes
Other Study ID Numbers: 2001P-000149, IRUSANAS0004
Study First Received: September 13, 2005
Last Updated: May 5, 2008
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:
Epilepsy
Hypogonadism
Seizures
Sexual Dysfunctions, Psychological
Erectile Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Gonadal Disorders
Endocrine System Diseases
Neurologic Manifestations
Signs and Symptoms
Sexual and Gender Disorders
Mental Disorders
Sexual Dysfunction, Physiological
Genital Diseases, Male
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Anastrozole
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014