Condition or disease | Intervention/treatment | Phase |
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Sperm DNA Fragmentation Infertility, Male | Drug: Escitalopram Other: Placebo | Phase 2 |
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 |
Arm | Intervention/treatment |
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Experimental: Escitalopram
10mg by mouth daily for 6 weeks
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Drug: Escitalopram
10mg by mouth daily for 6 weeks
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Placebo Comparator: Placebo
Matched placebo control by mouth for 6 weeks.
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Other: Placebo
matched placebo control by mouth for 6 weeks
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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 |
Inclusion Criteria:
Exclusion Criteria:
Contact: Adaobi Onunkwo | 646-962-0534 | ado2007@med.cornell.edu |
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 |
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 |
Tracking Information | ||||||||||
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First Submitted Date ICMJE | January 19, 2018 | |||||||||
First Posted Date ICMJE | May 16, 2018 | |||||||||
Last Update Posted Date | May 5, 2021 | |||||||||
Actual Study Start Date ICMJE | October 1, 2017 | |||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE |
Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks [ Time Frame: 6 weeks ] TUNEL assay for sperm DNA fragmentation
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Change History | ||||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
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Original Other Pre-specified Outcome Measures |
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Descriptive Information | ||||||||||
Brief Title ICMJE | Impact of Escitalopram on Sperm DNA Fragmentation | |||||||||
Official Title ICMJE | Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled | |||||||||
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). | |||||||||
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 Type ICMJE | Interventional | |||||||||
Study Phase ICMJE | Phase 2 | |||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | |||||||||
* 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 | Recruiting | |||||||||
Estimated Enrollment ICMJE |
70 | |||||||||
Original Estimated Enrollment ICMJE |
45 | |||||||||
Estimated Study Completion Date ICMJE | December 31, 2021 | |||||||||
Estimated Primary Completion Date | December 31, 2021 (Final data collection date for primary outcome measure) | |||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||||||||
Accepts Healthy Volunteers ICMJE | Yes | |||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | United States | |||||||||
Removed Location Countries | ||||||||||
Administrative Information | ||||||||||
NCT Number ICMJE | NCT03527043 | |||||||||
Other Study ID Numbers ICMJE | 1608017504 | |||||||||
Has Data Monitoring Committee | Not Provided | |||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Weill Medical College of Cornell University | |||||||||
Study Sponsor ICMJE | Weill Medical College of Cornell University | |||||||||
Collaborators ICMJE | Not Provided | |||||||||
Investigators ICMJE |
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PRS Account | Weill Medical College of Cornell University | |||||||||
Verification Date | May 2021 | |||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |