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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 is a Phase 2 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 69 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03038867
The ClinicalTrials.gov registry entry for NCT03038867 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Weill Medical College of Cornell University, which has 701 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03038867 reports 0 study locations.
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.
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