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Impact of Escitalopram on Sperm DNA Fragmentation

NCT03527043 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2025-08-06

Study results available
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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).

Conditions

  • Sperm DNA Fragmentation
  • Infertility, Male

Interventions

DRUG

Escitalopram

10mg by mouth daily for 6 weeks

OTHER

Placebo

matched placebo control by mouth for 6 weeks

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Jonathan Gal, MD · Weill Medical College of Cornell University

  • Peter Schlegel, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-01
Primary Completion
2023-04-04
Completion
2024-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03527043 on ClinicalTrials.gov