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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 Pharma
ClinicalTrials.gov Identifier:
NCT01091220
First received: March 19, 2010
Last updated: September 2, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Sperm Quality
Biological: Certolizumab pegol
Biological: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Cimzia®

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01091220

Locations
Belgium
Liège, Belgium
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma
ClinicalTrials.gov Identifier: NCT01091220     History of Changes
Other Study ID Numbers: CR0001, 2009-015216-17
Study First Received: March 19, 2010
Last Updated: September 2, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by UCB Pharma:
certolizumab pegol
Cimzia®
healthy male volunteers
sperm

Additional relevant MeSH terms:
Certolizumab pegol
Immunoglobulin Fab Fragments
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 27, 2014