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
  Purpose

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.


Condition Intervention
Healthy
Drug: paroxetine

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Biospecimen Retention:   Samples With DNA

Serum samples Semen samples


Enrollment: 35
Study Start Date: January 2007
Estimated Study Completion Date: September 2007
Intervention Details:
    Drug: paroxetine
    paroxetine 10-40mg daily x 5 weeks
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

community sample

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00385762

Locations
United States, New York
Department of Urology, Weill Medical College of Cornell University
New York, New York, United States, 10021
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Peter N. Schlegel, M.D. Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Peter N. Schlegel, M.D., Weill Cornell Medical College
ClinicalTrials.gov Identifier: NCT00385762     History of Changes
Other Study ID Numbers: 0605008515
Study First Received: October 9, 2006
Last Updated: November 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Weill Medical College of Cornell University:
Human volunteers

Additional relevant MeSH terms:
Paroxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014