Impact of Duloxetine on Male Fertility

NCT03038867 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1603017099
• Study Type: interventional
• Target: 69
• Locations: 1 country
• Sites: 1

Brief 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

Infertility, Male; Depression

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks

  Number of participants with TUNEL values \> 25% at 6 weeks in each treatment group

  6 Weeks (primary time point of interest)

• Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks

  Number of participants with Tunel Values \> 25% at 0 Weeks (baseline) in each treatment group

  0 weeks

• Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks

  Number of participants with Tunel values \> 25% at 2 weeks in each treatment group

  2 weeks

• Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks

  Number of participants with Tunel values \> 25% at 8 weeks in each treatment group

  8 weeks

• Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks

  Number of participants with Tunel values \> 25% at 10 weeks in each treatment group

  10 Weeks

Secondary Outcomes (50)

• Sperm Concentration at 0 Weeks

  0 weeks

• Sperm Concentration at 2 Weeks

  2 weeks

• Sperm Concentration at 6 Weeks

  6 weeks

• Sperm Concentration at 8 Weeks

  8 weeks

• Sperm Concentration at 10 Weeks

  10 Weeks

Study Arms (2)

Duloxetine

EXPERIMENTAL

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

Drug: Duloxetine

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Duloxetine DRUG

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

Duloxetine

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Infertility, Male; Depression

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Research coordinator
• Organization: Weill Cornell Medical College

mac4015@med.cornell.edu

212-746-5385

Study Officials

• Peter Schlegel, MD

  Weill Medical College of Cornell University

  STUDY CHAIR

• Nahid Punjani, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded, placebo-controlled, randomized controlled trial

Study Record Dates

• First Submitted: January 27, 2017
• First Posted: February 1, 2017
• Study Start: December 12, 2016
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: March 12, 2020
• Results First Posted: February 26, 2020

Record last verified: 2020-02

Locations

US (1)