Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00631696
First received: February 15, 2008
Last updated: September 24, 2012
Last verified: September 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy |
Drug: Pregabalin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) |
| Official Title: | Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS) [ Time Frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26) ] [ Designated as safety issue: No ]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 instead. Confidence intervals (CI) based on exact distribution.
Secondary Outcome Measures:
- Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS) [ Time Frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26) ] [ Designated as safety issue: No ]FSH minimum normal range 1.4 International units per liter (IU/L) to maximum normal range 18.1 IU/L. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.
- Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26 [ Time Frame: Baseline, Week 26 (last observation in the Week 26 window) ] [ Designated as safety issue: No ]FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.
- Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12 [ Time Frame: Baseline, Week 12 (last observation in the Week 12 window) ] [ Designated as safety issue: No ]FSH minimum normal range 1.4 IU/L to maximum normal range 18.1 IU/L. Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.
- Change From Baseline in Testosterone to End of Study (EOS) [ Time Frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26) ] [ Designated as safety issue: No ]End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.
- Change From Baseline in Testosterone to Week 26 [ Time Frame: Baseline, Week 26 (last observation in the Week 26 window) ] [ Designated as safety issue: No ]Week 26 was the non-missing value within 134 to 252 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 26 analysis.
- Change From Baseline in Testosterone to Week 12 [ Time Frame: Baseline, Week 12 (last observation in the Week 12 window) ] [ Designated as safety issue: No ]Week 12 was the last non-missing value within 2 to 133 days from Study Day 1. If there were multiple observations between the stated study days (all non-missing or a combination of missing and non-missing), then the latest non-missing value was selected for analysis. If all the values within the stated window were missing, then the records were not to be used for Week 12 analysis.
- Change From Baseline in Sperm Motility to End of Study (EOS) [ Time Frame: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26) ] [ Designated as safety issue: No ]Mean sperm motility (percent motility representing grade a+b [a=sperm with progressive, straight-line motility; b=non-linear motility]) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. End of study was the end of the washout period (Week 26) following 12 weeks of double-blind treatment. If the semen parameter was not assessed at Week 26, then the last assessment on or after Week 12 (end of treatment) was used instead.
- Change From Baseline in Sperm Motility to Week 26 [ Time Frame: Baseline, Week 26 (last observation in the Week 26 window) ] [ Designated as safety issue: No ]Mean sperm motility (percent motility representing grade a+b) was the average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 26 was average of the last 2 values within window of 134 to 252 days from Study Day 1 and at least 1 of the 2 values was non-missing. If only 1 assessment date within the stated window, Week 26 was the value of that single assessment. If all values within window were missing, the records were not to be used for Week 26 analysis.
- Change From Baseline in Sperm Motility to Week 12 [ Time Frame: Baseline, Week 12 (last observation in the Week 12 window) ] [ Designated as safety issue: No ]Mean sperm motility (percent motility representing grade a+b) was average of 2 samples collected at that visit. Normal value is ≥50% motility measured within 60 minutes of collection; higher values=greater percentage of sperm with motility. Week 12 was average of last 2 values within window of 2 to 133 days from Study Day 1 and at least 1 of the 2 values was non-missing. If there was only 1 assessment date within the stated window, then Week 12 was the value of that single assessment. If all the values within the window were missing, then the records were not to be used for Week 12 analysis.
| Enrollment: | 222 |
| Study Start Date: | February 2008 |
| Study Completion Date: | February 2012 |
| Primary Completion Date: | February 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Pregabalin
pregabalin 600 mg given twice a day
|
| Placebo Comparator: 2 |
Drug: Placebo
Placebo
|
Detailed Description:
This is a Phase 4 FDA commitment study. The purpose of the study is to evaluate the effects of pregabalin as compared to placebo on sperm concentration in healthy male subjects
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Healthy 18 to 55 years old males
Exclusion Criteria:
- Screening sperm count <20 x 106/mL; screening sperm motility <50% motile (a+b) or <25% Class "a" motile or screening sperm morphology <30% normal or semen volume <1.5 mL or white blood cell count >1 x 106 /mL on any screening visit sample
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00631696
Locations
| United States, Alabama | |
| Pfizer Investigational Site | |
| Mobile, Alabama, United States, 36607 | |
| United States, Arizona | |
| Pfizer Investigational Site | |
| Phoenix, Arizona, United States, 85013 | |
| United States, California | |
| Pfizer Investigational Site | |
| Tarzana, California, United States, 91356 | |
| United States, Florida | |
| Pfizer Investigational Site | |
| Ocala, Florida, United States, 34474 | |
| United States, Kentucky | |
| Pfizer Investigational Site | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Louisiana | |
| Pfizer Investigational Site | |
| Shreveport, Louisiana, United States, 71103 | |
| Pfizer Investigational Site | |
| Shrevport, Louisiana, United States, 71106 | |
| United States, Michigan | |
| Pfizer Investigational Site | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Pfizer Investigational Site | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Nevada | |
| Pfizer Investigational Site | |
| Las Vegas, Nevada, United States, 89148 | |
| United States, North Carolina | |
| Pfizer Investigational Site | |
| Durham, North Carolina, United States, 27713 | |
| United States, Rhode Island | |
| Pfizer Investigational Site | |
| Cumberland, Rhode Island, United States, 02864 | |
| United States, Texas | |
| Pfizer Investigational Site | |
| San Antonio, Texas, United States, 78229 | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00631696 History of Changes |
| Other Study ID Numbers: | A0081104 |
| Study First Received: | February 15, 2008 |
| Results First Received: | September 24, 2012 |
| Last Updated: | September 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Pfizer:
|
Healthy males Human volunteers pregabalin or placebo sperm quality and quantity |
Additional relevant MeSH terms:
|
Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 23, 2013