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NCT03038867 · ClinicalTrials.gov registry record · Phase 2
Impact of Duloxetine on Male Fertility
A Phase 2 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 2
- Development phase
- 69
- Enrollment target
NCT03038867: Completed Phase 2 study, sponsored by Weill Medical College of Cornell University.
NCT03038867 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 69 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03038867, a Phase 2 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 69 participants
- Enrollment target
Study 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.
Primary Outcome
Number of participants with TUNEL values \> 25% at 6 weeks in each treatment group
Interventions
- DRUG Placebo
- DRUG Duloxetine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2016-12-12 |
| Est. Completion | 2018-08-31 |
| Phase | Phase 2 |
What the finished NCT03038867 record still lists
NCT03038867 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03038867 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03038867 about?
NCT03038867 is a clinical study titled "Impact of Duloxetine on Male Fertility". 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 fr...
What is the current status of trial NCT03038867?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 69 participants. The study started on 2016-12-12. Estimated completion is 2018-08-31.
What interventions are being tested in trial NCT03038867?
The interventions under investigation include: Placebo (DRUG), Duloxetine (DRUG).
Who is sponsoring clinical trial NCT03038867?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03038867's enrollment target sits among peer trials
69 965th of 2000 higher than 1,034 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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