Impact of Duloxetine on Male Fertility

• Status: Completed
• Trial end date: 2018-08-31
• Target enrollment: 0
• Participant gender: Male

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Weill Medical College of Cornell University
• Treatments: Duloxetine Hydrochloride

Criteria

Inclusion Criteria:

• Healthy men aged 18-65 years old;

• normal or borderline semen analysis (sperm concentration > 10 million/mL, sperm motility > 30%, sperm morphology > 3%);

• willing to engage in sexual activity (alone or with a partner) at least once per week for the duration of the study;

• capable of providing semen sample.

Exclusion Criteria:

• Clinically detected varicocele;

• oligoasthenoteratospermia or azoospermia on semen analysis;

• ongoing attempts to initiate pregnancy;

• current sexual dysfunction (classified as moderate or worse on IIEF);

• history of seizure disorder;

• history of previous chemotherapy or radiation therapy;

• current psychiatric history or history of bipolar disorder;

• family history of bipolar disorder, depression, or suicide;

• use of any psychotropic medications or anticonvulsants;

• use of sleeping pills more than once per week;

• use of any hormonal medications on a daily or intermittent basis during the preceding 3 months;

• use of medications which may affect hormone measures and/or sexual function;

• inability to read, follow instructions, or complete questionnaires in English;

• consumption of tobacco or illicit drugs;

• consumption of >2oz of alcohol daily.