HealthyPhase 4NCT00631696

Evaluation Of Sperm Production With Healthy Male Volunteers Receiving Lyrica Or Placebo

A Phase 4 study testing Pregabalin in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: Pregabalin
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 222 participants
Where: 13 sitesUnited States
Study dates: Feb 2008to Feb 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Healthy 18 to 55 years old males

Who cannot join

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

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

United States13 sites

Pfizer Investigational Site
Ann Arbor, Michigan, 48109
Pfizer Investigational Site
Cumberland, Rhode Island, 02864
Pfizer Investigational Site
Durham, North Carolina, 27713
Pfizer Investigational Site
Las Vegas, Nevada, 89148
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Minneapolis, Minnesota, 55455
Pfizer Investigational Site
Mobile, Alabama, 36607
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Phoenix, Arizona, 85013
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Shreveport, Louisiana, 71103
Pfizer Investigational Site
Shreveport, Louisiana, 71106
Pfizer Investigational Site
Tarzana, California, 91356

Other trials in United States

About this study

Official title: Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo

Read the 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

Conditions: Healthy
Being tested: Pregabalin, Placebo
Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PregabalinDrug
pregabalin 600 mg given twice a day
PlaceboDrug
Placebo

Study groups in NCT00631696
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: Pregabalin
2	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With a 50 Percent (%) or More Reduction in Sperm Concentration From Baseline (Bsl) to End of Study (EOS)
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.
Measured: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)

Secondary outcomes (9)

Change From Baseline in Follicle Stimulating Hormone (FSH) to End of Study (EOS)
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.
Measured: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26
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.
Measured: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12
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.
Measured: Baseline, Week 12 (last observation in the Week 12 window)
Change From Baseline in Testosterone to End of Study (EOS)
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.
Measured: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Change From Baseline in Testosterone to Week 26
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.
Measured: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Testosterone to Week 12
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.
Measured: Baseline, Week 12 (last observation in the Week 12 window)
Change From Baseline in Sperm Motility to End of Study (EOS)
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.
Measured: Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)
Change From Baseline in Sperm Motility to Week 26
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.
Measured: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Sperm Motility to Week 12
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.
Measured: Baseline, Week 12 (last observation in the Week 12 window)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2008Feb 2012

First posted10 Mar 2008 (estimated)
Study startFeb 2008
Primary completionFeb 2012
Study completionFeb 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 222 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00631696
Sponsor's protocol ID: A0081104
Status last verified: Sep 2012
First submitted: 15 Feb 2008
Last updated: 26 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Sikka SC, Chen C, Almas M, Dula E, Knapp LE, Hellstrom WJ. Pregabalin does not affect sperm production in healthy volunteers: a randomized, double-blind, placebo-controlled, noninferiority study. Pain Pract. 2015 Feb;15(2):150-8. doi: 10.1111/papr.12171. Epub 2014 Jan 23.
PubMed 24450301

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective Randomized Double-Blind Study Of Sperm Production In Healthy Volunteers Receiving Pregabalin Or Placebo
ClinicalTrials.gov ID: NCT00631696
Acronym / sponsor ID: A0081104
Conditions: Healthy
Keywords: Healthy males Human volunteers pregabalin or placebo sperm quality and quantity
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 222 participants (actual)
Lead sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.Industry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Feb 2012 (actual)
Study completion: Feb 2012 (actual)
First posted: 10 Mar 2008 (estimated)
Results: Posted 24 Oct 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: Pregabalin
2	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 55 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (1 listed)

Healthy 18 to 55 years old males

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pregabalinpregabalin 600 mg given twice a day	Drug	1
PlaceboPlacebo	Drug	2

Primary outcome

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)
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.

9 secondary outcomes

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)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 26
Time frame: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Follicle Stimulating Hormone (FSH) to Week 12
Time frame: Baseline, Week 12 (last observation in the Week 12 window)
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)
Change From Baseline in Testosterone to Week 26
Time frame: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Testosterone to Week 12
Time frame: Baseline, Week 12 (last observation in the Week 12 window)
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)
Change From Baseline in Sperm Motility to Week 26
Time frame: Baseline, Week 26 (last observation in the Week 26 window)
Change From Baseline in Sperm Motility to Week 12
Time frame: Baseline, Week 12 (last observation in the Week 12 window)

Results and safety

Results posted to the registry on 24 Oct 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pregabalin	112	75
Placebo	110	70

Primary outcome: 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). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Pregabalin n = 65	Placebo n = 62
Value	9.2 (3.46 to 19.02)	3.2 (0.39 to 11.17)

Pregabalin vs Placebo: percentage difference: 6.0 (95% CI -2.29 to 14.30), Confidence Interval Approach

Population analysed: Per protocol analysis set: all randomized participants who had ≥8 weeks of study treatment, sperm concentration measurements at or after week 12 window, did not discontinue for site violations, and did not have any major protocol violations. N=number of participants with analyzable data at observation; Last observation carried forward (LOCF).

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment emergent Adverse Events are collected from the time of first dose of study treatment through last subject last visit (06 February 2012).. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pregabalin	0 of 111 (0%)	43 of 111 (38.7%)	Not reported
Placebo	0 of 109 (0%)	18 of 109 (16.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 24450301Sikka SC, Chen C, Almas M, Dula E, Knapp LE, Hellstrom WJ. Pregabalin does not affect sperm production in healthy volunteers: a randomized, double-blind, placebo-controlled, noninferiority study. Pain Pract. 2015 Feb;15(2):150-8. doi: 10.1111/papr.12171. Epub 2014 Jan 23.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Pregabalin in people with Healthy, run by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00631696, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.