SSRI Effects on Semen Parameters in Men

NCT00385762 | Completed Results FDA Drug

• 1 other identifier: 0605008515
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy

Keywords

Human volunteers

Outcome Measures

Primary Outcomes (4)

• Semen Volume

  measured in mL

  2 months post initial visit

• Sperm Concentration

  number of sperm per cubic centimeter of semen

  2 months post initial visit

• Sperm Motility

  percent of sperm with movement

  2 months post initial visit

• Sperm Morphology

  percent of sperm with normal shape

  2 months post initial visit

Interventions

paroxetine DRUG

paroxetine 10-40mg daily x 5 weeks

Also known as: Selective Serotonin Reuptake Inhibitor (SSRI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

community sample

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Department of Urology, Weill Medical College of Cornell University

New York, New York, 10021, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum samples Semen samples

MeSH Terms

Interventions

Paroxetine; Selective Serotonin Reuptake Inhibitors

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs

Results Point of Contact

• Title: Peter N Schlegel, MD
• Organization: Weill Cornell Medical College

pnschleg@med.cornell.edu

2127465491

Study Officials

• Peter N. Schlegel, M.D.

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2006
• First Posted: October 11, 2006
• Study Start: January 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: August 2, 2017
• Results First Posted: August 2, 2017

Record last verified: 2017-04

Locations

US (1)