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Impact of Escitalopram on Sperm DNA Fragmentation

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ClinicalTrials.gov Identifier: NCT03527043
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

Study Description
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Brief Summary:
Double-blind placebo-controlled randomized trial of daily escitalopram for 6 weeks in healthy men with normal semen analyses and no psychiatric history of depression, bipolar, mania or suicidal ideation. Hormone profiles, semen analysis, sperm DNA fragmentation, and sexual function will be measured at baseline, after 6 weeks of therapy, and 4 weeks after discontinuation of therapy (10 weeks into study).

Condition or disease Intervention/treatment Phase
Sperm DNA Fragmentation Infertility, Male Drug: Escitalopram Other: Placebo Phase 2

Detailed Description:
SSRI medications, specifically escitalopram is a very commonly prescribed medication among men of reproductive age. Significant evidence exists that they may be harmful for paternal fertility potential in both animal and human studies. However, high quality data is lacking, particularly among commonly used SSRI's such as escitalopram. As such, it is important to properly evaluate the potential effect of escitalopram in a randomized placebo controlled fashion. Results will be important in guiding urologists, psychiatrists and family practitioners regarding discussion surrounding SSRI use in their patients interested in fertility.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Escitalopram
10mg by mouth daily for 6 weeks
 Drug: Escitalopram
10mg by mouth daily for 6 weeks
Placebo Comparator: Placebo
Matched placebo control by mouth for 6 weeks.
 Other: Placebo
matched placebo control by mouth for 6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks [ Time Frame: 0 (baseline), 6 weeks ]
    TUNEL assay for sperm DNA fragmentation


Secondary Outcome Measures :
  1. Absolute change in sperm DNA fragmentation [ Time Frame: 0 (baseline), 6, 10 weeks ]
    TUNEL assay for sperm DNA fragmentation

  2. Changes in sperm motility [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of motile sperm in semen analysis

  3. Changes in progressive motility [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of progressive motile sperm in semen analysis

  4. Changes in viability [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Percentage of viable sperm in semen analysis

  5. Changes in concentration [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Sperm concentration (number of sperm/mL) in semen analysis


Other Outcome Measures:
  1. Change in serum testosterone (ng/dL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum testosterone measurement

  2. Change in serum luteinizing hormone (LH) (mIU/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum Luteinizing hormone measurement

  3. Change in serum follicle-stimulating hormone (FSH) (mIU/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    Serum follicle-stimulating hormone measurement

  4. Change in serum prolactin (ng/mL) [ Time Frame: 0 (baseline), 6, 10 weeks ]
    serum prolactin measurement

  5. Change in International Index of Erectile Function Survey [ Time Frame: 0 (Baseline), 6, 10 weeks ]
    International Index of Erectile Function (IIEF) Survey. Severe Erectile Dysfunction (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no Erectile Dysfunction (22-25)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Normal semen analyses, or semen analyses with at least 5 million sperm
  • Normal TUNEL value (<7%)
  • Willing to engage in at least weekly sexual activity, with a partner or alone for the duration of the 10-week study

Exclusion Criteria:

  • Azoospermia or severe oligospermia (<5million sperm per semen analysis)
  • Presently attempting to conceive pregnancy
  • Sexual dysfunction preventing ability to provide semen analysis throughout study or engage in weekly sexual activity
  • Current psychiatric disorder including: bipolar, mania, depression, generalized anxiety, social phobia, panic attacks, obsessive compulsive disorder, and schizophrenia.
  • Family history of bipolar disorder, or suicide (including 2nd degree relatives)
  • Present use of psychotropic agents (prescription or herbal) or anticonvulsants
  • Use of sleeping pills
  • Alcohol consumption greater that 2oz/day
  • Use of illicit drugs
  • Inability to read, follow instructions or complete questionnaires in English.
  • Use of hormonal medications in past 3 months (androgens, androgen blockade, anabolic steroids, estrogens, herbal)
  • Use of medications to enhance sexual function
  • History of chemotherapy or pelvic radiation
  • Use of Monoamine Oxidase inhibitors (MAOi's) or tricyclic antidepressants (TCAs) within 14 days
  • Liver disease
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03527043


Contacts
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Contact: Adaobi Onunkwo 646-962-0534 ado2007@med.cornell.edu

Locations
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United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Thomas Flynn    212-746-4739    thf3001@med.cornell.edu   
Contact: Monica Coniglio    2127466676    moc4008@med.cornell.edu   
Principal Investigator: Nahid Punjani, MD         
Sub-Investigator: Marc Goldstein, MD         
Sub-Investigator: James Kashanian, MD         
Sub-Investigator: Peter Schlegel, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Nahid Punjani, MD Weill Medical College of Cornell University
Principal Investigator: Peter Schlegel, MD Weill Medical College of Cornell University
Principal Investigator: Phil Bach, MD Weill Medical College of Cornell University
More Information
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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03527043    
Other Study ID Numbers: 1608017504
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Infertility
Infertility, Male
Citalopram
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
 Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs