NCT00179517

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
4.3 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2008

Completed
9.4 years until next milestone

Results Posted

Study results publicly available

August 8, 2017

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

6.8 years

First QC Date

September 13, 2005

Results QC Date

March 16, 2017

Last Update Submit

July 8, 2019

Conditions

Seizure DisorderHypogonadismErectile Dysfunction

Keywords

SeizureEpilepsyTestosteroneHormoneSexual DysfunctionHypogonadismMen

Outcome Measures

Primary Outcomes (1)

  • Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.

    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.

    3 month average

Secondary Outcomes (8)

  • The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo

    Assessed for 3 months

  • Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).

    Assessed for 3 months

  • Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).

    Assessed for 3 months

  • The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.

    Assessed for 3 months

  • Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).

    Assessed for 3 months

  • +3 more secondary outcomes

Study Arms (2)

depotestosterone plus anastrozole (T-A)

EXPERIMENTAL

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

depotestosterone plus placebo (T-P)

PLACEBO COMPARATOR

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

Interventions

Anastrozole 1mgDRUG
Also known as: Arimidex
depotestosterone plus anastrozole (T-A)
Placebo Oral TabletDRUG
depotestosterone plus placebo (T-P)

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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: 20096638BACKGROUND

MeSH Terms

Conditions

EpilepsyHypogonadismErectile DysfunctionSeizuresSexual Dysfunction, PhysiologicalMultiple Endocrine Neoplasia Type 1

Interventions

Anastrozole

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesGonadal DisordersEndocrine System DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

NitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Andrew G Herzog MD,MSc
Organization
Beth Israel Deaconess Medical Center
aherzog@bidmc.harvard.edu
781-431-0277

Study Officials

  • Andrew Herzog, M.D., M.Sc.

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

June 1, 2001

Primary Completion

April 1, 2008

Study Completion

April 1, 2008

Last Updated

July 17, 2019

Results First Posted

August 8, 2017

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)