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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03038867
Other study ID # 1603017099
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 12, 2016
Est. completion date August 31, 2018

Study information

Verified date February 2020
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Antidepressant medications are commonly prescribed in the USA not only for depression, but also for anxiety disorders such as generalized anxiety disorder and obsessive-compulsive disorder, premature ejaculation, post-traumatic stress disorder, and neuropathic pain. Despite being widely prescribed in the United States in men of reproductive age, the impact of antidepressants on fertility has not been extensively studied.

After noticing worsened semen parameters in men on anti-depressants, the investigators performed the first prospective study to demonstrate a deleterious impact of selective serotonin reuptake inhibitors (SSRI) on sperm DNA integrity, which has been linked to reproductive outcomes. Further small studies have corroborated the negative impact of SSRIs on male fertility, as assessed by semen parameters and/or sperm DNA integrity.

No studies have examined the impact of a newer, but similar, class of antidepressant - the serotonin-norepinephrine reuptake inhibitor (SNRI). Like SSRIs, SNRIs inhibit the reuptake of serotonin, but also act on norepinephrine. The use of SNRIs has increased recently due to their slightly improved efficacy profile when compared to SSRIs. Duloxetine is an SNRI and is one of the most commonly prescribed anti-depressants in the United States.

The investigators are conducting this trial to determine whether or not the administration of duloxetine will result in a deterioration in sperm DNA fragmentation in healthy, fertile men.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date August 31, 2018
Est. primary completion date August 31, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 65 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Duloxetine
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
Placebo
Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week

Locations

Country Name City State
United States Weill Cornell Medicine New York New York

Sponsors (1)

Lead Sponsor Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
Primary 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
Primary 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
Primary 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
Primary 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 Sperm Concentration at 0 Weeks Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks 0 weeks
Secondary Sperm Concentration at 2 Weeks Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks 2 weeks
Secondary Sperm Concentration at 6 Weeks Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks 6 weeks
Secondary Sperm Concentration at 8 Weeks Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks 8 weeks
Secondary Sperm Concentration at 10 Weeks Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks 10 Weeks
Secondary Sperm Motility at 0 Weeks Sperm motility (mean percent) at 0 weeks 0 weeks
Secondary Sperm Motility at 2 Weeks Sperm motility (mean percent) at 2 weeks 2 weeks
Secondary Sperm Motility at 6 Weeks Sperm motility (mean percent) at 6 weeks 6 weeks
Secondary Sperm Motility at 8 Weeks Sperm motility (mean percent) at 8 weeks 8 weeks
Secondary Sperm Motility at 10 Weeks Sperm motility (mean percent) at 10 weeks 10 Weeks
Secondary Sperm Head Defects at 0 Weeks Sperm head defects (mean number) at 0 weeks 0 weeks
Secondary Sperm Head Defects at 2 Weeks Sperm head defects (mean number) at 2 weeks 2 weeks
Secondary Sperm Head Defects at 6 Weeks Sperm head defects (mean number) at 6 weeks 6 weeks
Secondary Sperm Head Defects at 8 Weeks Sperm head defects (mean number) at 8 weeks 8 weeks
Secondary Sperm Head Defects at 10 Weeks Sperm head defects (mean number) at 10 weeks 10 Weeks
Secondary Sperm Neck Defects at 0 Weeks Sperm neck defects (mean number) at 0 weeks 0 weeks
Secondary Sperm Neck Defects at 2 Weeks Sperm neck defects (mean number) at 2 weeks 2 weeks
Secondary Sperm Neck Defects at 6 Weeks Sperm neck defects (mean number) at 6 weeks 6 weeks
Secondary Sperm Neck Defects at 8 Weeks Sperm neck defects (mean number) at 8 weeks 8 weeks
Secondary Sperm Neck Defects at 10 Weeks Sperm neck defects (mean number) at 10 weeks 10 Weeks
Secondary Sperm Tail Defects at 0 Weeks Sperm tail defects (mean number) at 0 weeks 0 weeks
Secondary Sperm Tail Defects at 2 Weeks Sperm tail defects (mean number) at 2 weeks 2 weeks
Secondary Sperm Tail Defects at 6 Weeks Sperm tail defects (mean number) at 6 weeks 6 weeks
Secondary Sperm Tail Defects at 8 Weeks Sperm tail defects (mean number) at 8 weeks 8 weeks
Secondary Sperm Tail Defects at 10 Weeks Sperm tail defects (mean number) at 10 weeks 10 Weeks
Secondary Testosterone Level at 0 Weeks Testosterone level (ng/dL) at 0 weeks 0 weeks
Secondary Testosterone Level at 2 Weeks Testosterone level (ng/dL) at 2 weeks 2 weeks
Secondary Testosterone Level at 6 Weeks Testosterone level (ng/dL) at 6 weeks 6 weeks
Secondary Testosterone Level at 8 Weeks Testosterone level (ng/dL) at 8 weeks 8 weeks
Secondary Testosterone Level at 10 Weeks Testosterone level (ng/dL) at 10 weeks 10 Weeks
Secondary Estrogen Level at 0 Weeks Estrogen level (pg/mL) at 0 weeks 0 weeks
Secondary Estrogen Level at 2 Weeks Estrogen level (pg/mL) at 2 weeks 2 weeks
Secondary Estrogen Level at 6 Weeks Estrogen level (pg/mL) at 6 weeks 6 weeks
Secondary Estrogen Level at 8 Weeks Estrogen level (pg/mL) at 8 weeks 8 weeks
Secondary Estrogen Level at 10 Weeks Estrogen level (pg/mL) at 10 weeks 10 Weeks
Secondary Prolactin Level at 0 Weeks Prolactin level (ng/mL) at 0 weeks 0 weeks
Secondary Prolactin Level at 2 Weeks Prolactin level (ng/mL) at 2 weeks 2 weeks
Secondary Prolactin Level at 6 Weeks Prolactin level (ng/mL) at 6 weeks 6 weeks
Secondary Prolactin Level at 8 Weeks Prolactin level (ng/mL) at 8 weeks 8 weeks
Secondary Prolactin Level at 10 Weeks Prolactin level (ng/mL) at 10 weeks 10 Weeks
Secondary Luteinizing Hormone Level at 0 Weeks Luteinizing hormone level (mIU/mL) at 0 weeks 0 weeks
Secondary Luteinizing Hormone Level at 2 Weeks Luteinizing hormone level (mIU/mL) at 2 weeks 2 weeks
Secondary Luteinizing Hormone Level at 6 Weeks Luteinizing hormone level (mIU/mL) at 6 weeks 6 weeks
Secondary Luteinizing Hormone Level at 8 Weeks Luteinizing hormone level (mIU/mL) at 8 weeks 8 weeks
Secondary Luteinizing Hormone Level at 10 Weeks Luteinizing hormone level (mIU/mL) at 10 weeks 10 Weeks
Secondary Follicle Stimulating Hormone Level at 0 Weeks Follicle stimulating hormone level (mIU/mL) at 0 weeks 0 weeks
Secondary Follicle Stimulating Hormone Level at 2 Weeks Follicle stimulating hormone level (mIU/mL) at 2 weeks 2 weeks
Secondary Follicle Stimulating Hormone Level at 6 Weeks Follicle stimulating hormone level (mIU/mL) at 6 weeks 6 weeks
Secondary Follicle Stimulating Hormone Level at 8 Weeks Follicle stimulating hormone level (mIU/mL) at 8 weeks 8 weeks
Secondary Follicle Stimulating Hormone Level at 10 Weeks Follicle stimulating hormone level (mIU/mL) at 10 weeks 10 Weeks
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