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NCT03527043 · ClinicalTrials.gov registry record · Phase 2

Impact of Escitalopram on Sperm DNA Fragmentation

A Phase 2 study, sponsored by Weill Medical College of Cornell University.

Terminated
Registry status
Phase 2
Development phase
75
Enrollment target

NCT03527043: Clinical Trial Phase 2 study, sponsored by Weill Medical College of Cornell University.

NCT03527043 is a Phase 2 study that was terminated before completion, run by Weill Medical College of Cornell University. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03527043, a Phase 2 study, was terminated before completion, sponsored by Weill Medical College of Cornell University.

TERMINATED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study 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).

Primary Outcome

TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (\>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment

Interventions

  • OTHER Placebo
  • DRUG Escitalopram

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2017-10-01
Est. Completion 2024-05-31
Phase Phase 2

Why NCT03527043 stopped before completion

NCT03527043 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT03527043 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03527043 about?

NCT03527043 is a clinical study titled "Impact of Escitalopram on Sperm DNA Fragmentation". 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 ...

What is the current status of trial NCT03527043?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2017-10-01. Estimated completion is 2024-05-31.

What interventions are being tested in trial NCT03527043?

The interventions under investigation include: Placebo (OTHER), Escitalopram (DRUG).

Who is sponsoring clinical trial NCT03527043?

This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03527043's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03527043, the US trial registry maintained by the National Library of Medicine. NCT03527043 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.