Phase 2 N=69 Randomized Triple-blind Other

Impact of Duloxetine on Male Fertility

Infertility, Male · Depression

Bottom Line

View on ClinicalTrials.gov: NCT03038867 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2020

Primary outcome: Primary: Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks — 0; 2 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Duloxetine (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Weill Medical College of Cornell University
Primary completion: Aug 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks	0; 2	—
PRIMARY Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks	0; 0	—
PRIMARY Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks	1; 2	—
PRIMARY Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks	1; 0	—
PRIMARY Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks	0; 2	—
SECONDARY Sperm Concentration at 0 Weeks	57.4; 50.2	—
SECONDARY Sperm Concentration at 2 Weeks	48.9; 50.0	—
SECONDARY Sperm Concentration at 6 Weeks	44.6; 43.9	—
SECONDARY Sperm Concentration at 8 Weeks	45.7; 47.1	—
SECONDARY Sperm Concentration at 10 Weeks	42.0; 42.7	—
SECONDARY Sperm Motility at 0 Weeks	61.7; 59.7	—
SECONDARY Sperm Motility at 2 Weeks	54.3; 55.2	—
SECONDARY Sperm Motility at 6 Weeks	57.2; 50.4	—
SECONDARY Sperm Motility at 8 Weeks	51.1; 58.5	—
SECONDARY Sperm Motility at 10 Weeks	54.4; 53.9	—
SECONDARY Sperm Head Defects at 0 Weeks	88.4; 89.9	—
SECONDARY Sperm Head Defects at 2 Weeks	91.5; 90.7	—
SECONDARY Sperm Head Defects at 6 Weeks	91.6; 91.3	—
SECONDARY Sperm Head Defects at 8 Weeks	92.3; 88.7	—
SECONDARY Sperm Head Defects at 10 Weeks	90.8; 88.3	—
SECONDARY Sperm Neck Defects at 0 Weeks	1.36; 2.55	—
SECONDARY Sperm Neck Defects at 2 Weeks	2.65; 1.00	—
SECONDARY Sperm Neck Defects at 6 Weeks	1.12; 0.62	—
SECONDARY Sperm Neck Defects at 8 Weeks	1.17; 0.50	—
SECONDARY Sperm Neck Defects at 10 Weeks	0.91; 1.55	—
SECONDARY Sperm Tail Defects at 0 Weeks	0.13; 1.89	—
SECONDARY Sperm Tail Defects at 2 Weeks	0.00; 1.66	—
SECONDARY Sperm Tail Defects at 6 Weeks	0.04; 2.64	—
SECONDARY Sperm Tail Defects at 8 Weeks	0.35; 1.25	—
SECONDARY Sperm Tail Defects at 10 Weeks	1.09; 0.96	—
SECONDARY Testosterone Level at 0 Weeks	464; 448	—
SECONDARY Testosterone Level at 2 Weeks	431; 482	—
SECONDARY Testosterone Level at 6 Weeks	485; 438	—
SECONDARY Testosterone Level at 8 Weeks	534; 460	—
SECONDARY Testosterone Level at 10 Weeks	445; 509	—
SECONDARY Estrogen Level at 0 Weeks	51.8; 58.5	—
SECONDARY Estrogen Level at 2 Weeks	53.0; 44.4	—
SECONDARY Estrogen Level at 6 Weeks	45.8; 43.5	—
SECONDARY Estrogen Level at 8 Weeks	49.3; 39.0	—
SECONDARY Estrogen Level at 10 Weeks	31.7; 133	—
SECONDARY Prolactin Level at 0 Weeks	11.9; 12.4	—
SECONDARY Prolactin Level at 2 Weeks	9.74; 11.3	—
SECONDARY Prolactin Level at 6 Weeks	10.3; 9.60	—
SECONDARY Prolactin Level at 8 Weeks	10.1; 8.98	—
SECONDARY Prolactin Level at 10 Weeks	8.83; 11.6	—
SECONDARY Luteinizing Hormone Level at 0 Weeks	4.11; 3.37	—
SECONDARY Luteinizing Hormone Level at 2 Weeks	4.00; 3.57	—
SECONDARY Luteinizing Hormone Level at 6 Weeks	4.51; 3.42	—
SECONDARY Luteinizing Hormone Level at 8 Weeks	4.18; 3.70	—
SECONDARY Luteinizing Hormone Level at 10 Weeks	4.98; 3.78	—
SECONDARY Follicle Stimulating Hormone Level at 0 Weeks	6.56; 5.26	—
SECONDARY Follicle Stimulating Hormone Level at 2 Weeks	5.56; 5.30	—
SECONDARY Follicle Stimulating Hormone Level at 6 Weeks	4.57; 5.14	—
SECONDARY Follicle Stimulating Hormone Level at 8 Weeks	4.18; 5.29	—
SECONDARY Follicle Stimulating Hormone Level at 10 Weeks	5.54; 5.95	—

Summary

The investigators are conducting a placebo-controlled, randomized control trial with duloxetine in healthy, fertile men not previously on any antidepressants. Participants will be randomized to either the duloxetine or placebo groups for 6 weeks. The investigators will assess changes in sperm DNA fragmentation at 0, 2, 6, 8, and 10 weeks. Other outcomes measured will include semen parameters (sperm concentration, motility, morphology), hormone levels (testosterone, estrogen, prolactin, LH, FSH), and sexual function (IIEF and MSHQ) surveys.

Eligibility Criteria

Inclusion Criteria

Healthy men aged 18-65 years old;
normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm motility > 30%, sperm morphology > 3%);
willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;
capable of providing semen sample.

Exclusion Criteria

Clinically detected varicocele;
oligoasthenoteratospermia or azoospermia on semen analysis;
ongoing attempts to initiate pregnancy;
current sexual dysfunction (classified as moderate or worse on IIEF);
history of seizure disorder;
history of previous chemotherapy or radiation therapy;
current psychiatric history or history of bipolar disorder;
family history of bipolar disorder, depression, or suicide;
use of any psychotropic medications or anticonvulsants;
use of sleeping pills more than once per week;
use of any hormonal medications on a daily or intermittent basis during the preceding 3 months;
use of medications which may affect hormone measures and/or sexual function;
inability to read, follow instructions, or complete questionnaires in English;
consumption of tobacco or illicit drugs;
consumption of >2oz of alcohol daily.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03038867). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.