Trial Outcomes & Findings for Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo (NCT NCT00179517)
NCT ID: NCT00179517
Last Updated: 2019-07-17
Results Overview
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.
COMPLETED
PHASE2
40 participants
3 month average
2019-07-17
Participant Flow
Participant milestones
| Measure |
Depotestosterone Plus Anastrozole (T-A)
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
|
Depotestosterone Plus Placebo (T-P)
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 Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Depotestosterone Plus Anastrozole (T-A)
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
|
Depotestosterone Plus Placebo (T-P)
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 Study
Withdrawal by Subject
|
2
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.3 years
STANDARD_DEVIATION 7.5 • n=18 Participants
|
42.7 years
STANDARD_DEVIATION 7.2 • n=19 Participants
|
43.0 years
STANDARD_DEVIATION 7.3 • n=37 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=18 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=37 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=18 Participants
|
19 Participants
n=19 Participants
|
37 Participants
n=37 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 Participants
n=18 Participants
|
19 Participants
n=19 Participants
|
37 Participants
n=37 Participants
|
|
Participants with Epilepsy
|
18 Participants
n=18 Participants
|
19 Participants
n=19 Participants
|
37 Participants
n=37 Participants
|
PRIMARY outcome
Timeframe: 3 month averageS-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.
Outcome measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
Change in S-Score
|
3.7 Scores on a Scale
Standard Deviation 1.6
|
2.5 Scores on a Scale
Standard Deviation 2.2
|
|
Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
Reynolds Questionnaire Change in R-Interest
|
2.4 Scores on a Scale
Standard Deviation 2.1
|
1.5 Scores on a Scale
Standard Deviation 2.6
|
|
Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
Reynolds Questionnaire Change in R-Activity
|
11.1 Scores on a Scale
Standard Deviation 25.7
|
4.7 Scores on a Scale
Standard Deviation 7.9
|
|
Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
Reynolds Questionnaire Change in R-Satisfaction
|
2.4 Scores on a Scale
Standard Deviation 3.7
|
2.1 Scores on a Scale
Standard Deviation 3.3
|
|
Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment.
Reynolds Questionnaire Change in R-Function
|
-1.7 Scores on a Scale
Standard Deviation 7.4
|
-1.3 Scores on a Scale
Standard Deviation 4.1
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsThe 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.
Outcome measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo
Normalization of S-Score
|
13 Participants
|
9 Participants
|
|
The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo
No Normalization of S-Score
|
5 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsBioavailable 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 measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
|
150.9 ng/dl
Standard Deviation 144.0
|
161.7 ng/dl
Standard Deviation 123.1
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsEstradiol 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 measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P).
|
-14.6 pg/mL
Standard Deviation 17.3
|
8.6 pg/mL
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsBioavailable 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.
Outcome measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo.
|
145.47 Ratio
Standard Deviation 143.00
|
12.78 Ratio
Standard Deviation 10.21
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsBioavailable 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.
Outcome measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
|
450.24 Ratio
Standard Deviation 193.17
|
482.65 Ratio
Standard Deviation 346.10
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsEstradiol 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.
Outcome measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P).
|
9.31 Ratio
Standard Deviation 8.84
|
53.80 Ratio
Standard Deviation 47.25
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsThe 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 measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P).
|
-2.0 number of seizures
Standard Deviation 1.2
|
-2.9 number of seizures
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Assessed for 3 monthsChanges 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.
Outcome measures
| Measure |
Depotestosterone Plus Anastrozole (T-A)
n=18 Participants
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
|
Depotestosterone Plus Placebo (T-P)
n=19 Participants
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
|
|---|---|---|
|
Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Change in Depression (Beck Depression Inventory II
|
-5.3 Scores on a scale
Standard Deviation 7.6
|
-6.4 Scores on a scale
Standard Deviation 9.4
|
|
Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Change in Vigor
|
4.6 Scores on a scale
Standard Deviation 5.9
|
4.8 Scores on a scale
Standard Deviation 7.6
|
|
Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Change in Fatigue
|
-6.0 Scores on a scale
Standard Deviation 5.4
|
-4.5 Scores on a scale
Standard Deviation 8.1
|
|
Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Change in Depression (POMS-D)
|
-5.6 Scores on a scale
Standard Deviation 0.6
|
-6.7 Scores on a scale
Standard Deviation 11.5
|
|
Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Change in Anxiety (POMS-T)
|
-3.0 Scores on a scale
Standard Deviation 5.8
|
-4.2 Scores on a scale
Standard Deviation 7.4
|
|
Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Change in Anger (POMS A)
|
-2.4 Scores on a scale
Standard Deviation 8.7
|
-2.6 Scores on a scale
Standard Deviation 8.9
|
|
Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P).
Change in Confusion (POMS-C)
|
-2.7 Scores on a scale
Standard Deviation 4.1
|
-2.7 Scores on a scale
Standard Deviation 5.7
|
Adverse Events
Depotestosterone Plus Anastrozole (T-A)
Depotestosterone Plus Placebo (T-P)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Andrew G Herzog MD,MSc
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place