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Trial record 29 of 304 for:    duloxetine

Impact of Duloxetine on Male Fertility

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ClinicalTrials.gov Identifier: NCT03038867
Recruitment Status : Recruiting
First Posted : February 1, 2017
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.

Condition or disease Intervention/treatment Phase
Infertility, Male Depression Drug: Duloxetine Other: Placebo Phase 4

Detailed 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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Blinded, placebo-controlled, randomized controlled trial
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
Primary Purpose: Other
Official Title: Impact of Duloxetine on Male Fertility
Actual Study Start Date : December 12, 2016
Estimated Primary Completion Date : September 30, 2018
Estimated Study Completion Date : December 31, 2018


Arm Intervention/treatment
Experimental: Duloxetine
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
Drug: Duloxetine
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week

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




Primary Outcome Measures :
  1. Change in proportion of patients with abnormal sperm DNA fragmentation [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    TUNEL assay


Secondary Outcome Measures :
  1. Change in sperm concentration [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Sperm concentration (number of sperm/mL) in semen analysis

  2. Change in sperm motility [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Percentage of motile sperm in semen analysis

  3. Change in sperm morphology [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Percentage of sperm with normal morphology in semen analysis

  4. Change in serum testosterone [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Serum testosterone (ng/dL)

  5. Change in serum estrogen [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Serum estrogen (pg/mL)

  6. Change in serum follicle-stimulating hormone (FSH) [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Serum follicle-stimulating hormone (mIU/mL)

  7. Change in serum luteinizing hormone (LH) [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Serum luteinizing hormone (mIU/mL)

  8. Change in serum prolactin [ Time Frame: Week 0, Week 2, Week 6, Week 8, Week 10 ]
    Serum prolactin (ng/mL)

  9. Change in International Index of Erectile Function [ Time Frame: Week 0, Week 6, Week 10 ]
    International Index of Erectile Function survey

  10. Change in Male Sexual Health Questionnaire [ Time Frame: Week 0, Week 6, Week 10 ]
    Male Sexual Health Questionnaire survey



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03038867


Contacts
Contact: Ryan Flannigan, MD 212-746-5470 ryf9003@med.cornell.edu
Contact: Adaobi Onunkwo 646-962-8311 ado2007@med.cornell.edu

Locations
United States, New York
Weill Cornell Medicine Recruiting
New York, New York, United States, 10065
Contact: Adaobi Onunkwo    646-962-8311    ado2007@med.cornell.edu   
Contact: Ryan Flannigan, MD    212-746-5470    ryf9003@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Peter Schlegel, MD Weill Cornell Medicine
Principal Investigator: Ryan Flannigan, MD Weill Cornell Medicine

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03038867     History of Changes
Other Study ID Numbers: 1603017099
First Posted: February 1, 2017    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Duloxetine Hydrochloride
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female
Serotonin and Noradrenaline Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Antidepressive Agents
Psychotropic Drugs
Dopamine Agents