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Trial record 47 of 51 for:    "Hypogonadism" | "Estrogens"

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

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ClinicalTrials.gov Identifier: NCT00179517
Recruitment Status : Completed
First Posted : September 16, 2005
Results First Posted : August 8, 2017
Last Update Posted : July 17, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Andrew Herzog, Beth Israel Deaconess Medical Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Conditions Seizure Disorder
Hypogonadism
Erectile Dysfunction
Interventions Drug: Anastrozole 1mg
Drug: Placebo Oral Tablet
Enrollment 40
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Period Title: Overall Study
Started 20 20
Completed 18 19
Not Completed 2 1
Reason Not Completed
Withdrawal by Subject             2             1
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P) Total
Hide Arm/Group Description

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Total of all reporting groups
Overall Number of Baseline Participants 18 19 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 18 participants 19 participants 37 participants
43.3  (7.5) 42.7  (7.2) 43.0  (7.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
18
 100.0%
19
 100.0%
37
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 18 participants 19 participants 37 participants
18
 100.0%
19
 100.0%
37
 100.0%
Participants with Epilepsy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants 19 participants 37 participants
18
 100.0%
19
 100.0%
37
 100.0%
1.Primary Outcome
Title Sexual Function Scores, Calculated Using S-Score and Reynolds’ Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
Hide 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 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.
Time Frame 3 month average
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: Scores on a Scale
Change in S-Score 3.7  (1.6) 2.5  (2.2)
Reynolds Questionnaire Change in R-Interest 2.4  (2.1) 1.5  (2.6)
Reynolds Questionnaire Change in R-Activity 11.1  (25.7) 4.7  (7.9)
Reynolds Questionnaire Change in R-Satisfaction 2.4  (3.7) 2.1  (3.3)
Reynolds Questionnaire Change in R-Function -1.7  (7.4) -1.3  (4.1)
2.Secondary Outcome
Title The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo
Hide 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 normalization of sexual scores were reported for anastrozole (T-A) treatment group and the placebo treatment group. Sexual scores were gathered once per month for three months with the average of the three months reported.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Measure Type: Count of Participants
Unit of Measure: Participants
Normalization of S-Score
13
  72.2%
9
  47.4%
No Normalization of S-Score
5
  27.8%
10
  52.6%
3.Secondary Outcome
Title Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
Hide 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.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: ng/dl
150.9  (144.0) 161.7  (123.1)
4.Secondary Outcome
Title Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
Hide 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.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: pg/mL
-14.6  (17.3) 8.6  (19.6)
5.Secondary Outcome
Title The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.
Hide 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 subject. The ratio between the average bioavailable testosterone level and average estradiol levels were reported.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: Ratio
145.47  (143.00) 12.78  (10.21)
6.Secondary Outcome
Title Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
Hide 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 between the average bioactive testosterone level and average luteinizing hormone levels were reported.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: Ratio
450.24  (193.17) 482.65  (346.10)
7.Secondary Outcome
Title Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
Hide 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 levels and average luteinizing hormone levels were reported.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: Ratio
9.31  (8.84) 53.80  (47.25)
8.Secondary Outcome
Title Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).
Hide 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.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: number of seizures
-2.0  (1.2) -2.9  (2.9)
9.Secondary Outcome
Title Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Hide 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 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.
Time Frame Assessed for 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description:

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

Overall Number of Participants Analyzed 18 19
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Change in Depression (Beck Depression Inventory II -5.3  (7.6) -6.4  (9.4)
Change in Vigor 4.6  (5.9) 4.8  (7.6)
Change in Fatigue -6.0  (5.4) -4.5  (8.1)
Change in Depression (POMS-D) -5.6  (0.6) -6.7  (11.5)
Change in Anxiety (POMS-T) -3.0  (5.8) -4.2  (7.4)
Change in Anger (POMS A) -2.4  (8.7) -2.6  (8.9)
Change in Confusion (POMS-C) -2.7  (4.1) -2.7  (5.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Hide Arm/Group Description

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 mg of anastrozole daily for the duration of the study.

Anastrozole 1mg

Each participant has biweekly intramuscular injections of 300 mg depotestosterone cypionate and takes 1 matching placebo tablet daily for the duration of the study.

Placebo Oral Tablet

All-Cause Mortality
Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Depotestosterone Plus Anastrozole (T–A) Depotestosterone Plus Placebo (T–P)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/18 (0.00%)   0/19 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Andrew G Herzog MD,MSc
Organization: Beth Israel Deaconess Medical Center
Phone: 781-431-0277
EMail: aherzog@bidmc.harvard.edu
Layout table for additonal information
Responsible Party: Andrew Herzog, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179517     History of Changes
Other Study ID Numbers: 2001P000149
IRUSANAS0004
First Submitted: September 13, 2005
First Posted: September 16, 2005
Results First Submitted: March 16, 2017
Results First Posted: August 8, 2017
Last Update Posted: July 17, 2019