Sperm QualityPhase 1NCT01091220
Evaluation of the Effects of Certolizumab Pegol on Semen Quality in Healthy Male Volunteers
A Phase 1 study testing Certolizumab pegol in people with Sperm Quality, run by UCB Pharma at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm Quality
- What is being tested?
- Certolizumab pegol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Mar 2010to Mar 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers with normal baseline semen quality parameters
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Sperm Quality
- Being tested
- Certolizumab pegol, Placebo
- Keywords
- certolizumab pegol, Cimzia®, healthy male volunteers, sperm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Certolizumab pegolBiological
Also called Cimzia®
400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously
PlaceboBiological
2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 0.9% saline Receives: Biological: Placebo |
| Certolizumab pegol | Experimental | Certolizumab pegol 400 mg Receives: Biological: Certolizumab pegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total sperm motility (%)
Measured: baseline to 99 days
Sperm morphology (%)
Measured: Baseline to 99 days
Secondary outcomes (6)
Progressive motility (%)
Measured: Baseline to 99 days
Non-progressive motility (%)
Measured: Baseline to 99 days
Sperm vitality (%)
Measured: Baseline to 99 days
Semen volume (mL)
Measured: Baseline to 99 days
Sperm count (millions)
Measured: Baseline to 99 days
Sperm concentration (millions/mL)
Measured: Baseline to 99 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091220
- Sponsor's protocol ID
- CR0001
- Other IDs
- 2009-015216-17, 2009
- Status last verified
- Mar 2011
- First submitted
- 19 Mar 2010
- Last updated
- 5 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01091220
- Acronym / sponsor ID
- CR0001
- Conditions
- Sperm Quality
- Keywords
- certolizumab pegol, Cimzia®, healthy male volunteers, sperm
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 23 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Biological: Placebo0.9% saline |
| Certolizumab pegol | Experimental | Biological: Certolizumab pegolCertolizumab pegol 400 mg |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male volunteers with normal baseline semen quality parameters
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Certolizumab pegolAlso: Cimzia®400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously | Biological | Certolizumab pegol |
| Placebo2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously | Biological | Placebo |
Primary outcome
Total sperm motility (%)
Time frame: baseline to 99 days
Sperm morphology (%)
Time frame: Baseline to 99 days
6 secondary outcomes
Progressive motility (%)
Time frame: Baseline to 99 days
Non-progressive motility (%)
Time frame: Baseline to 99 days
Sperm vitality (%)
Time frame: Baseline to 99 days
Semen volume (mL)
Time frame: Baseline to 99 days
Sperm count (millions)
Time frame: Baseline to 99 days
Sperm concentration (millions/mL)
Time frame: Baseline to 99 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
UCB Clinical Trial Call Center study director
+1 877 822 9493 (UCB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Certolizumab pegol in people with Sperm Quality, run by UCB Pharma at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total sperm motility (%) (time frame: baseline to 99 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2011.