Escitalopram for Male Infertility

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Male Infertility+1 MoreEscitalopram - Drug
Eligibility
18 - 65
Male
What conditions do you have?
Select

Study Summary

This trial is testing whether the drug escitalopram, given for 6 weeks, has any effect on healthy men's sperm. Hormone levels, sperm quality, and sexual function will be measured at the beginning and end of the trial.

Eligible Conditions
  • Infertility
  • Male Infertility
  • Sperm DNA Fragmentation

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 0 (baseline), 6, 10 weeks

Week 10
Change in International Index of Erectile Function Survey
0 (baseline), 6 weeks
Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks
Week 10
Absolute change in sperm DNA fragmentation
Change in serum follicle-stimulating hormone (FSH) (mIU/mL)
Change in serum luteinizing hormone (LH) (mIU/mL)
Change in serum prolactin (ng/mL)
Change in serum testosterone (ng/dL)
Changes in concentration
Changes in progressive motility
Changes in sperm motility
Changes in viability

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Escitalopram and Memantine
23%Sleepiness/Sedation
10%Headache
8%Diminished Sexual Drive
8%Reduced Salivation
8%Tension/Inner Unrest
8%Concentration Difficulties
6%Orthostatic Dizziness
6%Asthenia/Lassitude/Increased Fatigability
6%Constipation
6%Polyuria/Polydipsia
4%Erectile Dysfunction
4%Nausea/Vomiting
4%Failing Memory
2%Ejaculatory Dysfunction
2%Micturtion Disturbances
2%Reduced Duration of Sleep
2%Weight Gain
2%Increased Duration of Sleep
2%Diarrhea
2%Increased Dream Activity
2%Accomodation Disturbance
2%Increased Tendancy to Sweating
This histogram enumerates side effects from a completed 2019 Phase 4 trial (NCT01902004) in the Escitalopram and Memantine ARM group. Side effects include: Sleepiness/Sedation with 23%, Headache with 10%, Diminished Sexual Drive with 8%, Reduced Salivation with 8%, Tension/Inner Unrest with 8%.

Trial Design

2 Treatment Groups

Escitalopram
1 of 2
Placebo
1 of 2

Experimental Treatment

Non-Treatment Group

70 Total Participants · 2 Treatment Groups

Primary Treatment: Escitalopram · Has Placebo Group · Phase 2

Escitalopram
Drug
Experimental Group · 1 Intervention: Escitalopram · Intervention Types: Drug
Placebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 0 (baseline), 6, 10 weeks

Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor
989 Previous Clinical Trials
1,338,645 Total Patients Enrolled
Nahid Punjani, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
69 Total Patients Enrolled
Phil Bach, MDPrincipal InvestigatorWeill Medical College of Cornell University
Caroline Kang, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
40 Total Patients Enrolled
Peter Schlegel, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
69 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · Male Participants · 3 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
New York100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Weill Cornell Medicine100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Email100.0%