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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179517
First received: September 13, 2005
Last updated: July 7, 2017
Last verified: July 2017
  Purpose
The purpose of this study is to determine if treatment using a medication (anastrozole/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. Anastrozole, 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: Anastrozole 1mg Drug: Placebo Oral Tablet Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Comparison of Anastrozole 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 Andrew Herzog, Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. [ Time Frame: 3 month average ]
    S-Scores and Reynolds Questionnaire scores were assessed at baseline and once a month over three months. The average change in score for each questionnaire over the 3 month study was reported. The S-Scores questionnaire measured sexual function and consisted of four questions with five possible answers. The total scale range was 0-20, with higher scores were considered better. S-Scores that were greater than or equal to 16/20 were considered normalized S-Scores. Reynolds Questionnaire is a 21 item survey that monitors sexual interest, activity, satisfaction, and function. The scale for the Reynolds questionnaire for sexual interest was from 0-12, with higher scores being better. The scale for sexual activity was 0-41 with higher scores being better. The sexual satisfaction scale was from 0-21 with higher scores being better. The scale for sexual function was from 0 to -12 with lower scores being better.


Secondary Outcome Measures:
  • A Greater Proportion of Men Will Achieve Normalization of Sexual Scores (Sexual Interest Function) Using Anastrozole Than Placebo. [ Time Frame: 3 month average ]
    Normalization of S-Scores referred to scores greater that or equal to 16/20.

  • Bioactive Testosterone Levels Will Increase More With Anastrozole Than With Placebo. [ Time Frame: 3 month average ]
    Bioactive testosterone levels were measured at baseline and once a month over the three month study. The average change in bioactive testosterone levels from baseline to the end of the three month study was reported.

  • Estradiol Levels Will Decrease More With Anastrozole Than With Placebo. [ Time Frame: 3 month average ]
    Estradiol levels were measured once a month over the three month study in the treatment and placebo group. The average change in estradiol levels was reported.

  • The Bioactive Testosterone and Estradiol Ratio Will be Higher With Anastrozole Than With Placebo. [ Time Frame: 3 month average ]
    Bioactive Testosterone and estradiol levels were measured once a month over the three month study in the treatment and placebo group. The bioactive Testosterone and estradiol levels were averaged The ratio between the average bioactive testosterone level and average estradiol levels were reported.

  • Bioactive Testosterone and Luteinizing Hormone Ratios Will be Higher With Anastrozole Than Placebo. [ Time Frame: 3 month average ]
    Bioactive Testosterone and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The bioactive testosterone and luteinizing hormone levels were averaged. The ratio between the average bioactive testosterone level and average luteinizing hormone levels were reported.

  • Estradiol and Luteinizing Hormone Ratios Will be Lower With Anastrozole Than Placebo. [ Time Frame: 3 month average ]
    Estradiol and luteinizing hormone levels were measured once a month over the three month study in the treatment and placebo group. The estradiol and luteinizing hormone levels were averaged. The ratio between the average estradiol levels and average luteinizing hormone levels were reported.

  • Changes in Seizure Frequency Will be More Favorable With Anastrozole Than With Placebo. [ Time Frame: 3 month average ]
    The average change in number of seizures over the 3 month study for the depotestosterone plus anastrozole (T-A) and depotestosterone plus placebo (T-P) were reported.

  • Changes in Energy, Mood and Anxiety Scores Will be More Favorable With Anastrozole Than With Placebo. [ Time Frame: 3 month average ]
    Changes in energy, mood and anxiety scores were measured using The Beck Depression Inventory II and the POMS questionnaire. The Beck Depression Inventory II questionnaire consisted of 21 questions, each with answers ranging from 0-3. The answers for each question were summed. The scale ranged from 0-63 with higher scores meaning a higher depression score (worse score). The POMS questionnaire had a total of 65 questions that measured tension, depression, anger, vigor, fatigue and confusion. The total POMS score ranged from 0-200, with lower scores being better. The POMS tension score ranged from 0-36 with lower scores being better. The POMS depression score ranged from 0-60 with lower scores being better. The POMS anger score ranged from 0-48, lower scores being better. The POMS vigor score ranged from 0-32, lower scores being better. The POMS fatigue score ranged from 0-28, lower scores being better. The POMS confusion score ranged from 0-28 with lower scores being better.


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)
Arms Assigned Interventions
Experimental: depotestosterone plus anastrozole (T-A)
Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes an oral tablet of anastrozole 1 mg daily for the duration of the study. This group is referred to as the depotestosterone plus anastrozole (T-A) group.
Drug: Anastrozole 1mg
Other Name: Arimidex
Placebo Comparator: depotestosterone plus placebo (T-P)
Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo oral tablet daily for the duration of the study. This group is referred to as the depotestosterone plus placebo (T-P) group.
Drug: Placebo Oral Tablet

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 anastrozole 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   (Adult)
Sexes 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

Publications:
Responsible Party: Andrew Herzog, Professor of Neurology, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179517     History of Changes
Other Study ID Numbers: 2001P000149
IRUSANAS0004
Study First Received: September 13, 2005
Results First Received: March 16, 2017
Last Updated: July 7, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Andrew Herzog, Beth Israel Deaconess Medical Center:
Seizure
Epilepsy
Testosterone
Hormone
Sexual Dysfunction
Hypogonadism
Men

Additional relevant MeSH terms:
Epilepsy
Seizures
Erectile Dysfunction
Hypogonadism
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
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Anastrozole
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Anabolic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors

ClinicalTrials.gov processed this record on September 19, 2017