Evaluation Of Sperm Production With Healthy Male Voluntee... | NCT00631696

Evaluation Of Sperm Production With Healthy Male Voluntee... | NCT00631696 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
1	Experimental		Drug: Pregabalin
2	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Pregabalin	Drug	pregabalin 600 mg given twice a day	1
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	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

Measure	Description	Time Frame
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.

Contacts/Locations Module

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Mobile	Alabama	36607	United States
Pfizer Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24450301	Derived	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.

Label	URL
To obtain contact information for a study center near you, click here.	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Pregabalin	Pregabalin 50 milligrams (mg) by mouth (PO) twice a day (BID) starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
FG001	Placebo

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Comment	Reasons
Entered, not randomized to treatment		FG0001 subjects FG0011 subjects
Discontinued after database release date		FG0001 subjects FG0010 subjects
Follow up after database release date		FG0001 subjects FG0010 subjects
Lost to Follow-up		FG0007 subjects FG00110 subjects
Withdrawal by Subject		FG0002 subjects FG0019 subjects
Other		FG0008 subjects FG0018 subjects
Protocol Violation		FG0009 subjects FG0019 subjects
Study terminated by sponsor		FG0003 subjects FG0013 subjects
Adverse Event		FG0005 subjects FG0010 subjects

Arm/Group Information

ID	Title	Description
BG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
BG001	Placebo	Placebo matching pregabalin treatment.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000111 BG001109 BG002220

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Customized

Number

participants

Title

Denominators

Categories

Title	Measurements
	OG0009.2(3.46 to 19.02) OG0013.2(0.39 to 11.17)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Study powered to show non-inferiority (NI) of pregabalin (PGB) to placebo (PBO) on the percentage of participants (N) with a ≥50% reduction in MSC from Bsl to end of washout (Week (Wk) 26, or last assessment on or after Wk 12 if Wk 26 not done). NI to be declared if upper bound of 95% CI for difference between PGB and PBO not >20%. Assuming proportion of N with 50% reduction to be 6% for both groups, sample size N=65 per group would provide >90% power to show NI of PGB to PBO.	Confidence Interval Approach				percentage difference	6.0			2-Sided	95	-2.29	14.30			The confidence interval was based on asymptotic normal distribution.

Secondary

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.

Modified intent-to-treat (MITT) population included all randomized participants who received at least 1 dose of study medication (either pregabalin or placebo) and were not discontinued for major violation at the site level. N=number of participants with analyzable data at observation; LOCF.

Posted

Mean

Standard Deviation

IU/L

Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts

Secondary

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.

MITT population; N=number of participants (observed cases) with analyzable data at observation.

Posted

Mean

Standard Deviation

IU/L

Baseline, Week 26 (last observation in the Week 26 window)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts
Participants

Secondary

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.

MITT; N=number of participants with analyzable data at observation.

Posted

Mean

Standard Deviation

IU/L

Baseline, Week 12 (last observation in the Week 12 window)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts
Participants

Secondary

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.

MITT; N=number of participants with analyzable data at observation; LOCF.

Posted

Mean

Standard Deviation

nanograms per deciliter (ng/dL)

Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts
Participants	OG000

Secondary

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.

MITT; N=number of participants with analyzable data at observation.

Posted

Mean

Standard Deviation

ng/dL

Baseline, Week 26 (last observation in the Week 26 window)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts
Participants	OG000

Secondary

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.

MITT; N=number of participants with analyzable data at observation.

Posted

Mean

Standard Deviation

ng/dL

Baseline, Week 12 (last observation in the Week 12 window)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts
Participants	OG000

Secondary

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.

MITT; N=number of participants with analyzable data at observation; LOCF.

Posted

Mean

Standard Deviation

percent motility

Baseline, End of Study (last observation at Week 26 or last assessment on or after Week 12 if no data at Week 26)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts

Secondary

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.

MITT; N=number of participants with analyzable data at observation.

Posted

Mean

Standard Deviation

percent motility

Baseline, Week 26 (last observation in the Week 26 window)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts
Participants

Secondary

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.

MITT; N=number of participants with analyzable data at observation.

Posted

Mean

Standard Deviation

percent motility

Baseline, Week 12 (last observation in the Week 12 window)

ID	Title	Description
OG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.
OG001	Placebo	Placebo matching pregabalin treatment.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Pregabalin	Pregabalin 50 mg PO BID starting dose with a 2-week titration followed by a fixed dose of 300 mg PO BID for 10 weeks, a 1 week taper at Week 12, and a 13 week washout period up to Week 26.			0	111	43	111
EG001	Placebo	Placebo matching pregabalin treatment.			0	109	18	109

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA (14.0)	Non-systematic Assessment	EG0002 affected111 at risk EG0014 affected109 at risk
Fatigue	General disorders	MedDRA (14.0)	Non-systematic Assessment	EG0005 affected111 at risk EG0011 affected109 at risk
Muscle strain	Injury, poisoning and procedural complications	MedDRA (14.0)	Non-systematic Assessment	EG0004 affected111 at risk EG0011 affected109 at risk
Dizziness	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG00021 affected111 at risk EG0011 affected109 at risk
Headache	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0004 affected111 at risk EG0015 affected109 at risk
Paraesthesia	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG0004 affected111 at risk EG0011 affected109 at risk
Somnolence	Nervous system disorders	MedDRA (14.0)	Non-systematic Assessment	EG00011 affected111 at risk EG0015 affected109 at risk
Euphoric mood	Psychiatric disorders	MedDRA (14.0)	Non-systematic Assessment	EG0006 affected111 at risk EG0011 affected109 at risk

Ancestor Terms

ID	Term
D005680	gamma-Aminobutyric Acid
D000613	Aminobutyrates
D002087	Butyrates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000596	Amino Acids
D000602	Amino Acids, Peptides, and Proteins

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.3462	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	-0.12			2-Sided	95	-0.385	0.136			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.3652	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	-0.13			2-Sided	95	-0.420	0.156			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.1204	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	-0.20			2-Sided	95	-0.464	0.054			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.2875	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	24.65			2-Sided	95	-20.999	70.302			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.1699	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	32.93			2-Sided	95	-14.292	80.158			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.7958	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	-6.12			2-Sided	95	-52.804	40.558			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.4094	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	-1.08			2-Sided	95	-3.645	1.494			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.9064	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	-0.15			2-Sided	95	-2.649	2.352			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		ANCOVA		0.4666	p-value from analysis of covariance (ANCOVA) with treatment and center as main effects and baseline value as covariate in the model.	LS Mean Difference	-0.86			2-Sided	95	-3.207	1.477			Least Squares Mean (LS Mean) and 95% CI from ANCOVA with treatment and center as main effects and baseline value as covariate in the model. LS Mean Difference calculated as (Pregabalin - Placebo).		Superiority or Other (legacy)