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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
October 9, 2006
October 11, 2006
February 17, 2017
August 2, 2017
August 2, 2017
January 2007
September 2007   (Final data collection date for primary outcome measure)
  • Semen Volume [ Time Frame: 2 months post initial visit ]
    measured in mL
  • Sperm Concentration [ Time Frame: 2 months post initial visit ]
    number of sperm per cubic centimeter of semen
  • Sperm Motility [ Time Frame: 2 months post initial visit ]
    percent of sperm with movement
  • Sperm Morphology [ Time Frame: 2 months post initial visit ]
    percent of sperm with normal shape
Not Provided
Complete list of historical versions of study NCT00385762 on ClinicalTrials.gov Archive Site
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SSRI Effects on Semen Parameters in Men
Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters
According to the National Institute of Mental Health, depressive disorders afflict over six million U.S. men annually. Most cases of moderate or severe depression are treated with antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the past two years, prescribing data show a steady increase in antidepressant dispensing rates (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an effect on ejaculatory function and are therapeutically used for treatment of premature (rapid) ejaculation. However, few studies have evaluated the potential impact of antidepressant medications on male fertility, and no studies have been published with respect to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume male infertility practice at New York Hospital-Cornell Medical Center, several patients have presented who have had a clear temporal association between SSRI use and impairment in sperm motility and/or sperm transport (emission). These men have shown improvement in sperm counts and motility after discontinuation of antidepressant medications.
We propose a crossover pilot study of normal healthy males to ascertain possible effects of SSRIs on semen parameters. After initial screening semen analyses, subjects will take the SSRI paroxetine for five weeks. Serial semen analyses will be obtained while on medication and one month after discontinuation of medication. Comparisons between semen parameters on and off medication will be used to evaluate the frequency and significance of semen analysis changes during SSRI treatment.
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
Serum samples Semen samples
Non-Probability Sample
community sample
Healthy
Drug: paroxetine
paroxetine 10-40mg daily x 5 weeks
Other Name: Selective Serotonin Reuptake Inhibitor (SSRI)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
September 2007
September 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Normal, healthy male volunteers, ages 18-65
  • Must be able to swallow pills

Exclusion Criteria:

  • Known sexual dysfunction
  • Tobacco use
  • Prescription medications
  • History of psychiatric disorders
  • Previous chemotherapy or radiation treatment
  • History of seizure disorder
  • Alcohol use greater than 2 ounces daily
  • Illicit drug use
  • Azoospermia on screening semen analysis
  • Varicocele
  • Currently attempting to achieve pregnancy
Sexes Eligible for Study: Male
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00385762
0605008515
Not Provided
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Peter N. Schlegel, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
April 2017