Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

UCB, Inc.

ClinicalTrials.gov Identifier:

NCT01091220

First received: March 19, 2010

Last updated: September 2, 2011

Last verified: March 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

March 19, 2010

Last Updated Date

September 2, 2011

Start Date ^ICMJE

March 2010

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Total sperm motility (%) [ Time Frame: baseline to 99 days ] [ Designated as safety issue: Yes ]
Sperm morphology (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01091220 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Progressive motility (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Non-progressive motility (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Sperm vitality (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Semen volume (mL) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Sperm count (millions) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Sperm concentration (millions/mL) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Progressive motility (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Rapid progressive motility (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Slow progressive motility (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Non-progressive motility (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Sperm vitality (%) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Semen volume (mL) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Sperm count (millions) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]
Sperm concentration (millions/mL) [ Time Frame: Baseline to 99 days ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers

Official Title ^ICMJE

A Randomized, Single-center, Double-blind, Placebo-controlled Study to Explore the Effect of a Single Dose of Certolizumab Pegol 400 mg on Semen Quality in Healthy Male Volunteers

Brief Summary

The primary objective of this study is to evaluate the effect of certolizumab pegol (CZP) on the quality of sperm obtained from healthy male volunteers.

Detailed Description

CZP is a PEGylated humanized Fab' fragment with specificity for human tumor necrosis factor alpha (TNFα). Evidence suggests that modulation of TNFα signaling may affect male spermatogenesis. Therefore, this study will compare semen quality parameters before and after a single 400 mg dose of CZP, or matched placebo.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)

Condition ^ICMJE

Sperm Quality

Intervention ^ICMJE

Biological: Certolizumab pegol
400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously

Other Name: Cimzia®
Biological: Placebo
2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously

Study Arm (s)

Placebo Comparator: Placebo
0.9% saline

Intervention: Biological: Placebo
Experimental: Certolizumab pegol
Certolizumab pegol 400 mg

Intervention: Biological: Certolizumab pegol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

March 2011

Primary Completion Date

March 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy male volunteers with normal baseline semen quality parameters

Exclusion Criteria:

Previous participation in studies involving TNF inhibitors
Prior treatment with biologic response modifiers within 5 half-lives
History of trauma or surgery to the pelvis/genital area
Tests positive for tuberculosis, HIV, Hepatitis B or C

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01091220

Other Study ID Numbers ^ICMJE

CR0001, 2009-015216-17

Has Data Monitoring Committee

Responsible Party

UCB, Inc.

Study Sponsor ^ICMJE

UCB, Inc.

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

UCB Clinical Trial Call Center

+1 877 822 9493 (UCB)

Information Provided By

UCB, Inc.

Verification Date

March 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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