NCT03527043

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Oct 2017

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 19, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

May 16, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2024

Completed
10 months until next milestone

Results Posted

Study results publicly available

March 25, 2025

Completed
Last Updated

August 6, 2025

Status Verified

July 1, 2025

Enrollment Period

5.5 years

First QC Date

January 19, 2018

Results QC Date

January 17, 2025

Last Update Submit

July 25, 2025

Conditions

Sperm DNA FragmentationInfertility, Male

Outcome Measures

Primary Outcomes (1)

  • Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment

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

    6 weeks

Secondary Outcomes (2)

  • Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment)

    10 weeks

  • Absolute Change in DNA Fragmentation Percentage

    0 (baseline), 6, 10 weeks

Other Outcomes (5)

  • Serum Testosterone Measurement

    0 (baseline), 6, 10 weeks

  • Change in Serum Luteinizing Hormone (LH) (mIU/mL)

    0 (baseline), 6, 10 weeks

  • Change in Serum Follicle-stimulating Hormone (FSH) (mIU/mL)

    0 (baseline), 6, 10 weeks

  • +2 more other outcomes

Study Arms (2)

Escitalopram

EXPERIMENTAL

10mg by mouth daily for 6 weeks

Drug: Escitalopram

Placebo

PLACEBO COMPARATOR

Matched placebo control by mouth for 6 weeks.

Other: Placebo

Interventions

EscitalopramDRUG

10mg by mouth daily for 6 weeks

Escitalopram
PlaceboOTHER

matched placebo control by mouth for 6 weeks

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Infertility, Male

Interventions

Escitalopram

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Jonathan Gal
Organization
Weill Cornell Medicine
jog4018@med.cornell.edu
646-962-4811

Study Officials

  • Jonathan Gal, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

  • Peter Schlegel, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2018

First Posted

May 16, 2018

Study Start

October 1, 2017

Primary Completion

April 4, 2023

Study Completion

May 31, 2024

Last Updated

August 6, 2025

Results First Posted

March 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)