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

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

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00179517

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Principal Investigator: Andrew Herzog, M.D., M.Sc. Beth Israel Deaconess Medical Center
  More Information Identifier: NCT00179517     History of Changes
Other Study ID Numbers: 2001P-000149
Study First Received: September 13, 2005
Last Updated: May 5, 2008

Keywords provided by Beth Israel Deaconess Medical Center:
Sexual Dysfunction

Additional relevant MeSH terms:
Erectile Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Gonadal Disorders
Endocrine System Diseases
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors processed this record on July 19, 2017