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Completed

NCT Number: NCT01091220

Evaluation of the Effects of Certolizumab Pegol 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.

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Key information

Conditions

Sperm Quality

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Liège, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Certolizumab Pegol

Biological

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

Other names: Cimzia®

Placebo

Biological

2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously

Primary outcomes

  1. Total sperm motility (%)

    Time frame: baseline to 99 days

  2. Sperm morphology (%)

    Time frame: Baseline to 99 days

Secondary outcomes

  1. Progressive motility (%)

    Time frame: Baseline to 99 days

  2. Non-progressive motility (%)

    Time frame: Baseline to 99 days

  3. Sperm vitality (%)

    Time frame: Baseline to 99 days

  4. Semen volume (mL)

    Time frame: Baseline to 99 days

  5. Sperm count (millions)

    Time frame: Baseline to 99 days

  6. Sperm concentration (millions/mL)

    Time frame: Baseline to 99 days

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 23, 2010
Registry last updated
Sep 5, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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