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

September 2, 2011 updated by: UCB Pharma

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
0.9% saline
Biological: Placebo
2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously
Experimental: Certolizumab pegol
Certolizumab pegol 400 mg
Biological: Certolizumab pegol
400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously
Other Names:
  • Cimzia®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Total sperm motility (%)
Time Frame: baseline to 99 days
baseline to 99 days
Sperm morphology (%)
Time Frame: Baseline to 99 days
Baseline to 99 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Progressive motility (%)
Time Frame: Baseline to 99 days
Baseline to 99 days
Non-progressive motility (%)
Time Frame: Baseline to 99 days
Baseline to 99 days
Sperm vitality (%)
Time Frame: Baseline to 99 days
Baseline to 99 days
Semen volume (mL)
Time Frame: Baseline to 99 days
Baseline to 99 days
Sperm count (millions)
Time Frame: Baseline to 99 days
Baseline to 99 days
Sperm concentration (millions/mL)
Time Frame: Baseline to 99 days
Baseline to 99 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UCB Pharma

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

March 19, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 23, 2010

Study Record Updates

Last Update Posted (Estimate)

September 5, 2011

Last Update Submitted That Met QC Criteria

September 2, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR0001
  • 2009-015216-17 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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