SSRI Effects on Semen Parameters in Men

Healthy Clinical Trial

Official title:

Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00385762
• Other study ID #: 0605008515
• Status: Active, not recruiting
• Phase: N/A
• First received: October 9, 2006
• Last updated: November 4, 2010
• Start date: January 2007
• Est. completion date: September 2007

Study information

• Verified date: November 2010
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• paroxetine
paroxetine 10-40mg daily x 5 weeks

Locations

Country	Name	City	State
United States	Department of Urology, Weill Medical College of Cornell University	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States,