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Selective Serotonin Reuptake Inhibitor
Escitalopram for Sperm DNA Fragmentation
Phase 2
Recruiting
Led By Peter Schlegel, MD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (baseline), 6, 10 weeks
Awards & highlights
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.
Who is the study for?
Men with normal or slightly low sperm counts who are not currently trying to conceive and have no psychiatric disorders, liver disease, family history of bipolar disorder or suicide. Participants must be able to engage in weekly sexual activity and provide semen samples throughout the 10-week study.Check my eligibility
What is being tested?
The trial is testing if Escitalopram affects sperm DNA quality over a period of 6 weeks compared to a placebo. It's a double-blind study, meaning neither participants nor researchers know who gets the real drug. Measurements include hormone levels, semen analysis, and sexual function.See study design
What are the potential side effects?
Potential side effects from Escitalopram may include nausea, headache, trouble sleeping, dry mouth, increased sweating, feeling nervous or restless; sexual side effects like reduced libido or difficulty achieving orgasm can also occur.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 (baseline), 6, 10 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (baseline), 6, 10 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of patients converted from normal to abnormal sperm DNA fragmentation from baseline to 6 weeks
Secondary outcome measures
Absolute change in sperm DNA fragmentation
Changes in concentration
Changes in progressive motility
+2 moreOther outcome measures
Change in International Index of Erectile Function Survey
Change in serum follicle-stimulating hormone (FSH) (mIU/mL)
Change in serum luteinizing hormone (LH) (mIU/mL)
+2 moreSide effects data
From 2019 Phase 4 trial • 115 Patients • NCT0190200423%
Sleepiness/Sedation
10%
Headache
8%
Tension/Inner Unrest
8%
Reduced Salivation
8%
Concentration Difficulties
8%
Diminished Sexual Drive
6%
Asthenia/Lassitude/Increased Fatigability
6%
Constipation
6%
Polyuria/Polydipsia
6%
Orthostatic Dizziness
4%
Nausea/Vomiting
4%
Erectile Dysfunction
4%
Failing Memory
2%
Diarrhea
2%
Increased Duration of Sleep
2%
Reduced Duration of Sleep
2%
Increased Dream Activity
2%
Accomodation Disturbance
2%
Increased Tendancy to Sweating
2%
Weight Gain
2%
Ejaculatory Dysfunction
2%
Micturtion Disturbances
100%
80%
60%
40%
20%
0%
Study treatment Arm
Escitalopram and Placebo
Escitalopram and Memantine
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: EscitalopramExperimental Treatment1 Intervention
10mg by mouth daily for 6 weeks
Group II: PlaceboPlacebo Group1 Intervention
Matched placebo control by mouth for 6 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Escitalopram
2005
Completed Phase 4
~2330
Find a Location
Who is running the clinical trial?
Weill Medical College of Cornell UniversityLead Sponsor
1,055 Previous Clinical Trials
1,316,225 Total Patients Enrolled
Peter Schlegel, MDPrincipal InvestigatorWeill Medical College of Cornell University
1 Previous Clinical Trials
69 Total Patients Enrolled
Jonathan Gal, MDPrincipal InvestigatorWeill Medical College of Cornell University
2 Previous Clinical Trials
140 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I haven't taken MAO inhibitors or tricyclic antidepressants in the last 14 days.I have a liver condition.I am willing to be sexually active weekly for 10 weeks.I have a diagnosed psychiatric condition like depression or anxiety.My family has a history of bipolar disorder or suicide.I am currently taking medication for mental health or seizures.I use sleeping pills.I use medication to improve sexual function.I have had chemotherapy or radiation to the pelvis.I have not used hormonal medications in the last 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: Escitalopram
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are senior citizens included in the recruitment of this trial?
"This research study is open to participants of age 18-65."
Answered by AI
What research has been performed with regards to Escitalopram?
"Currently, 23 clinical trials are researching the efficacy of Escitalopram with 5 in their final stage. Cincinnati is a major hub for this research, but there has been work done across 45 medical centres."
Answered by AI
How many participants are taking part in this experiment?
"Affirmative. Clinicaltrials.gov records evidence that this medical trial is currently seeking patients and was first advertised on October 1st 2017 with the latest update from April 29th 2022. A total of 70 individuals must be recruited from a single location for the study to reach fruition."
Answered by AI
Has Escitalopram obtained the necessary regulatory sanction?
"Considering its Phase 2 status, our team at Power gave escitalopram a score of two due to the availability of safety data but lack thereof in regards to efficacy."
Answered by AI
Is this research endeavor currently open to participants?
"Evidently, this medical trial is still recruiting participants. It was first advertised on October 1st 2017 and last modified on April 29th 2022 according to the published data from clinicaltrials.gov."
Answered by AI
What qualifications must a participant possess in order to join this research initiative?
"To be suitable for inclusion in this research, participants must have azoospermia and be within the 18 to 65 age range. Approximately 70 individuals are sought out for their contribution."
Answered by AI
Who else is applying?
What state do they live in?
New York
How old are they?
18 - 65
What site did they apply to?
Weill Cornell Medicine
What portion of applicants met pre-screening criteria?
Met criteria
How responsive is this trial?
Typically responds via
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