drugset / Trial / NCT03038867

Impact of Duloxetine on Male Fertility

NCT03038867

Phase 2 Completed 69 enrolled Weill Medical College of Cornell University
RandomizedParallel-groupTriple-blindOther

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.

Timeline

Start
2016-12-12
Primary completion
2018-08-31
Completion
2018-08-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Duloxetine Small molecule 60 mg Oral