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Effectiveness of Celecoxib After Surgical Sperm Retrieval

This study has been terminated.
(Interim analysis demonstrated significant benefit in intervention arm)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01323595
First Posted: March 25, 2011
Last Update Posted: December 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Weill Medical College of Cornell University
Results First Submitted: October 29, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition: Pain
Interventions: Drug: Celecoxib
Drug: Sugar Pill

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients undergoing testicular sperm extraction surgery

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No exclusions except allergy to treatment agent (celecoxib)

Reporting Groups
  Description
Celecoxib

Celecoxib will be given for 5 days after surgery

Celecoxib : Celecoxib 200mg PO BID x 6 days

Sugar Pill

Sugar pill for 5 days after surgery.

Sugar Pill : Sugar pill PO BID x 6 days


Participant Flow:   Overall Study
    Celecoxib   Sugar Pill
STARTED   39   39 
COMPLETED   16 [1]   18 [2] 
NOT COMPLETED   23   21 
[1] Remaining subjects did not return questionnaire
[2] Remaining subjects did not return questionaire



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Celecoxib

Celecoxib will be given for 6 days after surgery

Celecoxib : Celecoxib 200mg PO BID x 6 days

Sugar Pill

Sugar pill for 6 days after surgery.

Sugar Pill : Sugar pill PO BID x 6 days

Total Total of all reporting groups

Baseline Measures
   Celecoxib   Sugar Pill   Total 
Overall Participants Analyzed 
[Units: Participants]
 39   39   78 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      39 100.0%      39 100.0%      78 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 39  (5)   35  (5)   37  (5) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      0   0.0%      0   0.0% 
Male      39 100.0%      39 100.0%      78 100.0% 
Region of Enrollment 
[Units: Participants]
     
United States   39   39   78 


  Outcome Measures

1.  Primary:   Level of Pain   [ Time Frame: 1 week after surgery ]

2.  Secondary:   Bleeding Complications   [ Time Frame: 7 days after surgery ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Chairman, Department of Urology
Organization: Weill Cornell Medical College
phone: 212 746-5491
e-mail: pnschleg@med.cornell.edu



Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01323595     History of Changes
Other Study ID Numbers: 1010011319
First Submitted: March 24, 2011
First Posted: March 25, 2011
Results First Submitted: October 29, 2013
Results First Posted: July 11, 2014
Last Update Posted: December 8, 2017