Trial Outcomes & Findings for Impact of Escitalopram on Sperm DNA Fragmentation (NCT NCT03527043)

Last Updated: 2025-08-06

Results Overview

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

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

75 participants

Primary outcome timeframe

6 weeks

Results posted on

2025-08-06

Participant Flow

Participant milestones

Participant milestones
Measure	Escitalopram 10mg by mouth daily for 6 weeks Escitalopram: 10mg by mouth daily for 6 weeks	Placebo Matched placebo control by mouth for 6 weeks. Placebo: matched placebo control by mouth for 6 weeks
Overall Study STARTED	37	38
Overall Study COMPLETED	36	38
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Escitalopram 10mg by mouth daily for 6 weeks Escitalopram: 10mg by mouth daily for 6 weeks	Placebo Matched placebo control by mouth for 6 weeks. Placebo: matched placebo control by mouth for 6 weeks
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Impact of Escitalopram on Sperm DNA Fragmentation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Escitalopram n=37 Participants 10mg by mouth daily for 6 weeks Escitalopram: 10mg by mouth daily for 6 weeks	Placebo n=38 Participants Matched placebo control by mouth for 6 weeks. Placebo: matched placebo control by mouth for 6 weeks	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=93 Participants	38 Participants n=4 Participants	75 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	37 Participants n=93 Participants	38 Participants n=4 Participants	75 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=93 Participants	34 Participants n=4 Participants	70 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	5 Participants n=93 Participants	1 Participants n=4 Participants	6 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	17 Participants n=93 Participants	16 Participants n=4 Participants	33 Participants n=27 Participants
Race (NIH/OMB) White	11 Participants n=93 Participants	12 Participants n=4 Participants	23 Participants n=27 Participants
Race (NIH/OMB) More than one race	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	4 Participants n=4 Participants	5 Participants n=27 Participants

PRIMARY outcome

Timeframe: 6 weeks

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

Outcome measures

Outcome measures
Measure	Escitalopram n=37 Participants 10mg by mouth daily for 6 weeks Escitalopram: 10mg by mouth daily for 6 weeks	Placebo n=38 Participants Matched placebo control by mouth for 6 weeks. Placebo: matched placebo control by mouth for 6 weeks
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment	27 Percentage	21.05 Percentage

SECONDARY outcome

Timeframe: 10 weeks

Tunnel assay of the DNA fragmentation, Percentage of patients who have abnormal DNA fragmentation levels at 10 weeks (4 weeks following cessation of treatment)