SSRI Effects on Semen Parameters in Men
Recruitment status was Active, not recruiting
| Tracking Information | |||||
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| First Received Date ICMJE | October 9, 2006 | ||||
| Last Updated Date | November 4, 2010 | ||||
| Start Date ICMJE | January 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00385762 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | SSRI Effects on Semen Parameters in Men | ||||
| Official Title ICMJE | Effect of Selective Serotonin Reuptake Inhibitor Antidepressants on Semen Parameters | ||||
| 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. 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Serum samples Semen samples |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | community sample |
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| Condition ICMJE | Healthy | ||||
| Intervention ICMJE | Drug: paroxetine
paroxetine 10-40mg daily x 5 weeks |
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| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 35 | ||||
| Estimated Completion Date | September 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00385762 | ||||
| Other Study ID Numbers ICMJE | 0605008515 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Peter N. Schlegel, M.D., Weill Cornell Medical College | ||||
| Study Sponsor ICMJE | Weill Medical College of Cornell University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Weill Medical College of Cornell University | ||||
| Verification Date | November 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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