At a glance
ClinicalIndex Comparison Record- ✓Healthy men aged 18-65 years
- ✓Normal or borderline semen analysis: sperm concentration >10 million/mL, motility >30%, morphology >3%
- ✓Willing to engage in sexual activity at least once per week during the study
- ✓Capable of providing semen sample
- ✕Oligoasthenoteratospermia or azoospermia on semen analysis
- ✕Clinically detected varicocele
- ✕Ongoing attempts to initiate pregnancy
- ✕Current sexual dysfunction (moderate or worse on IIEF)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Impact of Duloxetine on Male Fertility
In Brief
A Phase 2 clinical trial evaluating Duloxetine and Placebo for Infertility, Male and Depression. Completed, enrolled 69 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week