SSRI Effects on Semen Parameters in Men
Recruitment status was Active, not recruiting
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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 |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
community sample
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| United States, New York | |
| Department of Urology, Weill Medical College of Cornell University | |
| New York, New York, United States, 10021 | |
| 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 May 19, 2013