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SSRI Effects on Semen Parameters in Men

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00385762
First Posted: October 11, 2006
Last Update Posted: August 2, 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: February 17, 2017  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Healthy
Intervention: Drug: paroxetine

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Paroxetine Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.

Participant Flow:   Overall Study
    Paroxetine
STARTED   35 
COMPLETED   33 
NOT COMPLETED   2 
Adverse Event                1 
Lost to Follow-up                1 



  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.
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Reporting Groups
  Description
Paroxetine Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily.

Baseline Measures
   Paroxetine 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      35 100.0% 
>=65 years      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      0   0.0% 
Male      35 100.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Semen Volume   [ Time Frame: 2 months post initial visit ]

2.  Primary:   Sperm Concentration   [ Time Frame: 2 months post initial visit ]

3.  Primary:   Sperm Motility   [ Time Frame: 2 months post initial visit ]

4.  Primary:   Sperm Morphology   [ Time Frame: 2 months post initial visit ]


  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
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  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: Peter N Schlegel, MD
Organization: Weill Cornell Medical College
phone: 2127465491
e-mail: pnschleg@med.cornell.edu



Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00385762     History of Changes
Other Study ID Numbers: 0605008515
First Submitted: October 9, 2006
First Posted: October 11, 2006
Results First Submitted: February 17, 2017
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017