Expired Study
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Boston, Massachusetts 02115


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

2001P000149


NCT ID:

NCT00179517


Secondary ID:

IRUSANAS0004


Study Acronym:


Brief Title:

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


Official Title:

Comparison of Anastrozole and Testosterone Versus Placebo and Testosterone Treatment of Reproductive and Sexual Dysfunction in Men With Epilepsy and Hypogonadism


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Male


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Beth Israel Deaconess Medical Center


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Andrew Herzog, M.D., M.Sc.
Principal Investigator
Beth Israel Deaconess Medical Center

Study Dates

Start Date:June 2001
Completion Date:April 2008
Completion Type:Actual
Primary Completion Date:April 2008
Primary Completion Type:Actual
Verification Date:July 2019
Last Changed Date:July 8, 2019
First Received Date:September 13, 2005
First Results Date:March 16, 2017

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Time Frame:Assessed for 3 months
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).
Time Frame:Assessed for 3 months
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
Time Frame:Assessed for 3 months
Safety Issues:False
Description: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 for the three months. The ratio between the average estradiol lev
Outcome Type:Secondary Outcome
Measure:Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
Time Frame:Assessed for 3 months
Safety Issues:False
Description:Bioavailable 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 for the three months. The ratio betw
Outcome Type:Secondary Outcome
Measure:The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.
Time Frame:Assessed for 3 months
Safety Issues:False
Description:Bioavailable testosterone and estradiol levels were measured once a month over the three month study in subjects taking anastrozole and subjects taking placebo. The bioavailable testosterone and estradiol levels for the three months were averaged for each
Outcome Type:Secondary Outcome
Measure:Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
Time Frame:Assessed for 3 months
Safety Issues:False
Description:Estradiol levels were measured once a month over the three month study in subjects taking anastrozole (T-A) and in subjects taking placebo (T-P). The average change in estradiol levels was reported.
Outcome Type:Secondary Outcome
Measure:Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
Time Frame:Assessed for 3 months
Safety Issues:False
Description:Bioavailable 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.
Outcome Type:Secondary Outcome
Measure:The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo
Time Frame:Assessed for 3 months
Safety Issues:False
Description:The proportion of men who achieve normalization of sexual scores (scores greater than or equal to 16/20) on anastrozole (T-A) and those on placebo (T-P) are reported. Both Men who achieve normalization of sexual scores and those who did not achieve normal
Outcome Type:Primary Outcome
Measure: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
Safety Issues:False
Description: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 consis

Study Interventions

Intervention Type:Drug
Name:Anastrozole 1mg
Arm Name:depotestosterone plus anastrozole (T-A)
Other Name:Arimidex
Intervention Type:Drug
Name:Placebo Oral Tablet
Arm Name:depotestosterone plus placebo (T-P)

Study Arms

Study Arm Type:Experimental
Arm Name:depotestosterone plus anastrozole (T-A)
Description: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.
Study Arm Type:Placebo Comparator
Arm Name:depotestosterone plus placebo (T-P)
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Beth Israel Deaconess Medical Center
Agency Class:Industry
Agency Type:Collaborator
Agency Name:AstraZeneca

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation:Herzog AG, Farina EL, Drislane FW, Schomer DL, Smithson SD, Fowler KM, Dworetzky BA, Bromfield EB. A comparison of anastrozole and testosterone versus placebo and testosterone for treatment of sexual dysfunction in men with epilepsy and hypogonadism. Epilepsy Behav. 2010 Feb;17(2):264-71. doi: 10.1016/j.yebeh.2009.12.003. Epub 2010 Jan 21.
PMID:20096638

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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