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Impact of Duloxetine on Male Fertility

NCT03038867 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-03-12

Study results available
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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.

Conditions

Interventions

DRUG

Duloxetine

Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week

DRUG

Placebo

Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Peter Schlegel, MD · Weill Medical College of Cornell University

  • Nahid Punjani, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2018-08-31
Completion
2018-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03038867 on ClinicalTrials.gov