Phase 4
N=222
Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT00631696 ↗Enrolled (actual)
222
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcome: Primary: Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS) — 9.2; 3.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pregabalin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS) |
9.2; 3.2 | — |
| SECONDARY Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS) |
3.17; 3.68; 0.14; 0.22 | 0.3462 |
| SECONDARY Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26 |
3.20; 3.69; 0.16; 0.21 | 0.3652 |
| SECONDARY Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12 |
3.17; 3.68; -0.05; 0.08 | 0.1204 |
| SECONDARY Change From Baseline in Testosterone to End of Study (EOS) |
518.2; 481.8; 10.4; 0.8 | 0.2875 |
| SECONDARY Change From Baseline in Testosterone to Week 26 |
517.9; 474.6; 13.8; 2.6 | 0.1699 |
| SECONDARY Change From Baseline in Testosterone to Week 12 |
518.2; 481.8; -14.8; 0.0 | 0.7958 |
| SECONDARY Change From Baseline in Sperm Motility to End of Study (EOS) |
61.9; 61.4; -3.2; -1.8 | 0.4094 |
| SECONDARY Change From Baseline in Sperm Motility to Week 26 |
61.8; 61.2; -2.6; -1.8 | 0.9064 |
| SECONDARY Change From Baseline in Sperm Motility to Week 12 |
61.95; 61.38; -3.94; -2.71 | 0.4666 |
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.
Eligibility Criteria
Inclusion Criteria
- Healthy 18 to 55 years old males
Exclusion Criteria
- Screening sperm count 1 x 106 /mL on any screening visit sample
Data sourced from ClinicalTrials.gov (NCT00631696). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.