SSRI Effects on Semen Parameters in Men

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Weill Medical College of Cornell University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00385762
First received: October 9, 2006
Last updated: November 4, 2010
Last verified: November 2010

October 9, 2006
November 4, 2010
January 2007
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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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

Serum samples Semen samples

Non-Probability Sample

community sample

Healthy
Drug: paroxetine
paroxetine 10-40mg daily x 5 weeks
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
35
September 2007
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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
Male
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00385762
0605008515
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Peter N. Schlegel, M.D., Weill Cornell Medical College
Weill Medical College of Cornell University
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Principal Investigator: Peter N. Schlegel, M.D. Weill Medical College of Cornell University
Weill Medical College of Cornell University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP