SSRI Effects on Semen Parameters in Men

NCT ID: NCT00385762

Last Updated: 2017-08-02

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-09-30

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.

Detailed Description

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.

Conditions

Healthy

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

paroxetine

paroxetine 10-40mg daily x 5 weeks

Intervention Type: DRUG

Other Intervention Names

Selective Serotonin Reuptake Inhibitor (SSRI)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter N. Schlegel, M.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Department of Urology, Weill Medical College of Cornell University

New York, New York, United States

Countries

United States

Other Identifiers

0605008515

Identifier Type: -

Identifier Source: org_study_id