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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: Completed Phase 4 study, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Baseline is the average of sperm concentrations from semen samples collected on or before Study Day 1. End of study is average of sperm concentrations from semen samples collected at end of washout period (Week 26) following 12 weeks of double-blind treatment. Mean sperm concentration (MSC) of a visit is average of the 2 sperm concentration samples collected at that visit. If sperm concentration was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used
Interventions
- DRUG Placebo
- DRUG Pregabalin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-02 |
| Phase | Phase 4 |
What the finished NCT00631696 record still lists
NCT00631696 is an interventional study that assigns participants to a tested intervention. The registered 222 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00631696 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00631696's enrollment target sits among peer trials
222 383rd of 2000 higher than 1,618 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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