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NCT00179517 · ClinicalTrials.gov registry record · Phase 2
Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo
A Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
NCT00179517: Completed Phase 2 study, sponsored by Beth Israel Deaconess Medical Center.
NCT00179517 is a Phase 2 study that has completed, run by Beth Israel Deaconess Medical Center. The registered enrollment target is 40 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00179517, a Phase 2 study, has completed, sponsored by Beth Israel Deaconess Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
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 it
Interventions
- DRUG Placebo Oral Tablet
- DRUG Anastrozole 1mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2001-06 |
| Est. Completion | 2008-04 |
| Phase | Phase 2 |
What the finished NCT00179517 record still lists
NCT00179517 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Oral Tablet is the first listed.
NCT00179517 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00179517 about?
NCT00179517 is a clinical study titled "Treatment of Sexual Dysfunction in Hypogonadal Men With Epilepsy With Testosterone and Either Anastrozole or Placebo". 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 dysfu...
What is the current status of trial NCT00179517?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2001-06. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00179517?
The interventions under investigation include: Placebo Oral Tablet (DRUG), Anastrozole 1mg (DRUG).
Who is sponsoring clinical trial NCT00179517?
This trial is sponsored by Beth Israel Deaconess Medical Center, which has 488 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00179517's enrollment target sits among peer trials
40 1362nd of 2000 higher than 542 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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