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

Sperm Quality Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01091220
• Other study ID #: CR0001
• Secondary ID: 2009-015216-17
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2010
• Last updated: September 2, 2011
• Start date: March 2010
• Est. completion date: March 2011

Study information

• Verified date: March 2011
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Sperm Quality

Intervention

Biological:
• Certolizumab pegol
400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously
• Placebo
2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total sperm motility (%)		baseline to 99 days	Yes
Primary	Sperm morphology (%)		Baseline to 99 days	Yes
Secondary	Progressive motility (%)		Baseline to 99 days	Yes
Secondary	Non-progressive motility (%)		Baseline to 99 days	Yes
Secondary	Sperm vitality (%)		Baseline to 99 days	Yes
Secondary	Semen volume (mL)		Baseline to 99 days	Yes
Secondary	Sperm count (millions)		Baseline to 99 days	Yes
Secondary	Sperm concentration (millions/mL)		Baseline to 99 days	Yes