Trial · NCT00179517
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
NCT00179517, Phase 2, Completed, Beth Israel Deaconess Medical Center; results first posted 2017-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo. Trials, record NCT00179517. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00179517
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
- NCT number
- NCT00179517
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 40 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Seizure Disorder, Hypogonadism, Erectile Dysfunction
- Interventions
- Anastrozole 1mg, Placebo Oral Tablet
- First posted
- 2005-09-16
- Last updated
- 2019-07-17
- Results first posted
- 2017-08-08
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | 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 | The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo | Assessed for 3 months | 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. |
| Secondary | Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). | Assessed for 3 months | 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. |
| Secondary | Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). | Assessed for 3 months | 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. |
| Secondary | The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo. | Assessed for 3 months | 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. |
| Secondary | Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). | Assessed for 3 months | 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. |
| Secondary | Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). | Assessed for 3 months | 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. |
| Secondary | Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P). | Assessed for 3 months | 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. |
| Secondary | Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P). | Assessed for 3 months | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | 3 month average | Scores on a Scale | MEAN | |
| SECONDARY | The Proportion of Men Who Achieve Normalization of Sexual Scores (Sexual Interest Function,) Using Anastrozole and Placebo | Assessed for 3 months | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Bioavailable Testosterone Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). | Assessed for 3 months | ng/dl | MEAN | |
| SECONDARY | Estradiol Levels in Subjects on Anastrozole (T-A) and Subjects on Placebo (T-P). | Assessed for 3 months | pg/mL | MEAN | |
| SECONDARY | The Bioavailable Testosterone and Estradiol Ratio in Subjects Taking Anastrozole and Subjects Taking Placebo. | Assessed for 3 months | Ratio | MEAN | |
| SECONDARY | Bioavailable Testosterone and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). | Assessed for 3 months | Ratio | MEAN | |
| SECONDARY | Estradiol and Luteinizing Hormone Ratios in Subjects Taking Anastrozole (T-A) and in Subjects Taking Placebo (T-P). | Assessed for 3 months | Ratio | MEAN | |
| SECONDARY | Changes in Seizure Frequency in Subjects Taking Anastrozole (T-A) and Subjects Taking Placebo (T-P). | Assessed for 3 months | number of seizures | MEAN | |
| SECONDARY | Changes in Energy, Mood and Anxiety Scores for Subjects Taking Anastrozole (T-A) and for Subjects Taking Placebo (T-P). | Assessed for 3 months | Scores on a scale | MEAN |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Anastrozole (T-A) | Change in S-Score | 3.7 | Standard Deviation 1.6 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Placebo (T-P) | Change in S-Score | 2.5 | Standard Deviation 2.2 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Anastrozole (T-A) | Reynolds Questionnaire Change in R-Interest | 2.4 | Standard Deviation 2.1 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Placebo (T-P) | Reynolds Questionnaire Change in R-Interest | 1.5 | Standard Deviation 2.6 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Anastrozole (T-A) | Reynolds Questionnaire Change in R-Activity | 11.1 | Standard Deviation 25.7 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Placebo (T-P) | Reynolds Questionnaire Change in R-Activity | 4.7 | Standard Deviation 7.9 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Anastrozole (T-A) | Reynolds Questionnaire Change in R-Satisfaction | 2.4 | Standard Deviation 3.7 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Placebo (T-P) | Reynolds Questionnaire Change in R-Satisfaction | 2.1 | Standard Deviation 3.3 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Anastrozole (T-A) | Reynolds Questionnaire Change in R-Function | -1.7 | Standard Deviation 7.4 | Scores on a Scale |
| Sexual Function Scores, Calculated Using S-Score and Reynolds' Sexual Questionnaires, Will Increase More Anastrozole and Testosterone Treatment Than With Placebo and Testosterone Treatment. | Depotestosterone Plus Placebo (T-P) | Reynolds Questionnaire Change in R-Function | -1.3 | Standard Deviation 4.1 | Scores on a Scale |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Depotestosterone Plus Anastrozole (T-A) | 20 | |
| Overall Study | STARTED | Depotestosterone Plus Placebo (T-P) | 20 | |
| Overall Study | COMPLETED | Depotestosterone Plus Anastrozole (T-A) | 18 | |
| Overall Study | COMPLETED | Depotestosterone Plus Placebo (T-P) | 19 | |
| Overall Study | NOT COMPLETED | Depotestosterone Plus Anastrozole (T-A) | 2 | |
| Overall Study | NOT COMPLETED | Depotestosterone Plus Placebo (T-P) | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Depotestosterone Plus Anastrozole (T-A) | 0 | 18 |
| Total, all-cause mortality | Depotestosterone Plus Placebo (T-P) | 0 | 19 |
| Total, other adverse events | Depotestosterone Plus Anastrozole (T-A) | 0 | 18 |
| Total, other adverse events | Depotestosterone Plus Placebo (T-P) | 0 | 19 |
| Total, serious adverse events | Depotestosterone Plus Anastrozole (T-A) | 0 | 18 |
| Total, serious adverse events | Depotestosterone Plus Placebo (T-P) | 0 | 19 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 20096638 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Depotestosterone Plus Anastrozole (T-A) vs Depotestosterone Plus Placebo (T-P): deaths from any cause | Trial comparisons |
| Depotestosterone Plus Anastrozole (T-A) vs Depotestosterone Plus Placebo (T-P): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00179517
GET https://conductscience.org/api/trials/v1/NCT00179517/results?page=2