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NCT00631696 · ClinicalTrials.gov registry record · Phase 4
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
A Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- Completed
- Registry status
- Phase 4
- Development phase
- 222
- Enrollment target
NCT00631696 is a Phase 4 study that has completed, run by Pfizer's Upjohn has merged with Mylan to form Viatris. The registered enrollment target is 222 participants.
The verdict
NCT00631696, a Phase 4 study, has completed, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 222 participants
- Enrollment target
Study Summary
This study is being performed as a Phase IV FDA commitment study and is being powered adequately to assess changes in sperm concentration, FSH and testosterone in healthy male subjects treated with pregabalin as compared to placebo, in addition to confirming lack of effects on sperm motility.
Interventions
- DRUG Placebo
- DRUG Pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00631696
The ClinicalTrials.gov registry entry for NCT00631696 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00631696 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00631696 about?
NCT00631696 is a clinical study titled "Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo". This study is being performed as a Phase IV FDA commitment study and is being powered adequately to assess changes in sperm concentration, FSH and testosterone in healthy male subjects treated with pregabalin as compared to placebo, in addition to confirming lack of effects on sperm motility.
What is the current status of trial NCT00631696?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 222 participants. The study started on 2008-02. Estimated completion is 2012-02.
What interventions are being tested in trial NCT00631696?
The interventions under investigation include: Placebo (DRUG), Pregabalin (DRUG).
Who is sponsoring clinical trial NCT00631696?
This trial is sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris, which has 158 total clinical trials registered on ClinicalTrials.gov.
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