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
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
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
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: DrugPlacebo
Other
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: OtherTreatment
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
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| New York | 100.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Weill Cornell Medicine | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
How responsive is this trial?
Typically responds via
| 100.0% | |
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Conditions
Cancer Related
Treatments