Depression, Infertility, Male
Conditions
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.
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.
Interventions
DRUGDuloxetine
Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
DRUGPlacebo
Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
Intervention model description
Blinded, placebo-controlled, randomized controlled trial
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks | 6 Weeks (primary time point of interest) | Number of participants with TUNEL values \> 25% at 6 weeks in each treatment group |
| Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks | 0 weeks | Number of participants with Tunel Values \> 25% at 0 Weeks (baseline) in each treatment group |
| Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks | 2 weeks | Number of participants with Tunel values \> 25% at 2 weeks in each treatment group |
| Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks | 8 weeks | Number of participants with Tunel values \> 25% at 8 weeks in each treatment group |
| Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks | 10 Weeks | Number of participants with Tunel values \> 25% at 10 weeks in each treatment group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sperm Tail Defects at 10 Weeks | 10 Weeks | Sperm tail defects (mean number) at 10 weeks |
| Testosterone Level at 0 Weeks | 0 weeks | Testosterone level (ng/dL) at 0 weeks |
| Testosterone Level at 2 Weeks | 2 weeks | Testosterone level (ng/dL) at 2 weeks |
| Testosterone Level at 6 Weeks | 6 weeks | Testosterone level (ng/dL) at 6 weeks |
| Testosterone Level at 8 Weeks | 8 weeks | Testosterone level (ng/dL) at 8 weeks |
| Testosterone Level at 10 Weeks | 10 Weeks | Testosterone level (ng/dL) at 10 weeks |
| Estrogen Level at 0 Weeks | 0 weeks | Estrogen level (pg/mL) at 0 weeks |
| Estrogen Level at 2 Weeks | 2 weeks | Estrogen level (pg/mL) at 2 weeks |
| Estrogen Level at 6 Weeks | 6 weeks | Estrogen level (pg/mL) at 6 weeks |
| Estrogen Level at 8 Weeks | 8 weeks | Estrogen level (pg/mL) at 8 weeks |
| Sperm Concentration at 0 Weeks | 0 weeks | Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks |
| Sperm Concentration at 2 Weeks | 2 weeks | Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks |
| Sperm Concentration at 6 Weeks | 6 weeks | Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks |
| Sperm Concentration at 8 Weeks | 8 weeks | Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks |
| Sperm Concentration at 10 Weeks | 10 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks |
| Sperm Motility at 0 Weeks | 0 weeks | Sperm motility (mean percent) at 0 weeks |
| Sperm Motility at 2 Weeks | 2 weeks | Sperm motility (mean percent) at 2 weeks |
| Sperm Motility at 6 Weeks | 6 weeks | Sperm motility (mean percent) at 6 weeks |
| Sperm Motility at 8 Weeks | 8 weeks | Sperm motility (mean percent) at 8 weeks |
| Sperm Motility at 10 Weeks | 10 Weeks | Sperm motility (mean percent) at 10 weeks |
| Sperm Head Defects at 0 Weeks | 0 weeks | Sperm head defects (mean number) at 0 weeks |
| Sperm Head Defects at 2 Weeks | 2 weeks | Sperm head defects (mean number) at 2 weeks |
| Sperm Head Defects at 6 Weeks | 6 weeks | Sperm head defects (mean number) at 6 weeks |
| Sperm Head Defects at 8 Weeks | 8 weeks | Sperm head defects (mean number) at 8 weeks |
| Sperm Head Defects at 10 Weeks | 10 Weeks | Sperm head defects (mean number) at 10 weeks |
| Sperm Neck Defects at 0 Weeks | 0 weeks | Sperm neck defects (mean number) at 0 weeks |
| Sperm Neck Defects at 2 Weeks | 2 weeks | Sperm neck defects (mean number) at 2 weeks |
| Sperm Neck Defects at 6 Weeks | 6 weeks | Sperm neck defects (mean number) at 6 weeks |
| Sperm Neck Defects at 8 Weeks | 8 weeks | Sperm neck defects (mean number) at 8 weeks |
| Estrogen Level at 10 Weeks | 10 Weeks | Estrogen level (pg/mL) at 10 weeks |
| Prolactin Level at 0 Weeks | 0 weeks | Prolactin level (ng/mL) at 0 weeks |
| Prolactin Level at 2 Weeks | 2 weeks | Prolactin level (ng/mL) at 2 weeks |
| Prolactin Level at 6 Weeks | 6 weeks | Prolactin level (ng/mL) at 6 weeks |
| Prolactin Level at 8 Weeks | 8 weeks | Prolactin level (ng/mL) at 8 weeks |
| Prolactin Level at 10 Weeks | 10 Weeks | Prolactin level (ng/mL) at 10 weeks |
| Luteinizing Hormone Level at 0 Weeks | 0 weeks | Luteinizing hormone level (mIU/mL) at 0 weeks |
| Luteinizing Hormone Level at 2 Weeks | 2 weeks | Luteinizing hormone level (mIU/mL) at 2 weeks |
| Luteinizing Hormone Level at 6 Weeks | 6 weeks | Luteinizing hormone level (mIU/mL) at 6 weeks |
| Luteinizing Hormone Level at 8 Weeks | 8 weeks | Luteinizing hormone level (mIU/mL) at 8 weeks |
| Luteinizing Hormone Level at 10 Weeks | 10 Weeks | Luteinizing hormone level (mIU/mL) at 10 weeks |
| Follicle Stimulating Hormone Level at 0 Weeks | 0 weeks | Follicle stimulating hormone level (mIU/mL) at 0 weeks |
| Follicle Stimulating Hormone Level at 2 Weeks | 2 weeks | Follicle stimulating hormone level (mIU/mL) at 2 weeks |
| Follicle Stimulating Hormone Level at 6 Weeks | 6 weeks | Follicle stimulating hormone level (mIU/mL) at 6 weeks |
| Sperm Neck Defects at 10 Weeks | 10 Weeks | Sperm neck defects (mean number) at 10 weeks |
| Follicle Stimulating Hormone Level at 10 Weeks | 10 Weeks | Follicle stimulating hormone level (mIU/mL) at 10 weeks |
| Follicle Stimulating Hormone Level at 8 Weeks | 8 weeks | Follicle stimulating hormone level (mIU/mL) at 8 weeks |
| Sperm Tail Defects at 0 Weeks | 0 weeks | Sperm tail defects (mean number) at 0 weeks |
| Sperm Tail Defects at 2 Weeks | 2 weeks | Sperm tail defects (mean number) at 2 weeks |
| Sperm Tail Defects at 6 Weeks | 6 weeks | Sperm tail defects (mean number) at 6 weeks |
| Sperm Tail Defects at 8 Weeks | 8 weeks | Sperm tail defects (mean number) at 8 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Duloxetine Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
Duloxetine: Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week | 37 |
| Placebo Placebo
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week | 32 |
| Total | 69 |
Baseline characteristics
| Characteristic | Placebo | Total | Duloxetine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 69 Participants | 37 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 32 Participants | 69 Participants | 37 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 32 Participants | 69 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 37 | 0 / 32 |
| other Total, other adverse events | 0 / 37 | 0 / 32 |
| serious Total, serious adverse events | 0 / 37 | 0 / 32 |
Outcome results
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
Time frame: 0 weeks
Population: 5 patients in the Duloxetine group did not have Tunel data measured at 0 weeks (patients were not available)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duloxetine | Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks | 0 Participants |
| Placebo | Number of Participants With Abnormal Sperm DNA Fragmentation at 0 Weeks | 0 Participants |
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
Time frame: 10 Weeks
Population: 18 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 10 weeks (patients were not available).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duloxetine | Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks | 0 Participants |
| Placebo | Number of Participants With Abnormal Sperm DNA Fragmentation at 10 Weeks | 2 Participants |
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
Time frame: 2 weeks
Population: 12 patients in the Duloxetine group and 2 patients in the Placebo group did not have Tunel data at 2 weeks (patients were not available).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duloxetine | Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks | 1 Participants |
| Placebo | Number of Participants With Abnormal Sperm DNA Fragmentation at 2 Weeks | 2 Participants |
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
Time frame: 6 Weeks (primary time point of interest)
Population: 11 patients in the Duloxetine group and 7 patients in the Placebo group did not have Tunel data measured at 6 weeks (patients were not available).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duloxetine | Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks | 0 Participants |
| Placebo | Number of Participants With Abnormal Sperm DNA Fragmentation at 6 Weeks | 2 Participants |
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
Time frame: 8 weeks
Population: 15 patients in the Duloxetine group and 4 patients in the Placebo group did not have Tunel data at 8 weeks (patients were not available).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Duloxetine | Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks | 1 Participants |
| Placebo | Number of Participants With Abnormal Sperm DNA Fragmentation at 8 Weeks | 0 Participants |
Secondary
Estrogen Level at 0 Weeks
Estrogen level (pg/mL) at 0 weeks
Time frame: 0 weeks
Population: 6 patients in the Duloxetine group and 3 patients in the Placebo group did not have estrogen measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Estrogen Level at 0 Weeks | 51.8 pg/mL | Standard Deviation 39.4 |
| Placebo | Estrogen Level at 0 Weeks | 58.5 pg/mL | Standard Deviation 51.9 |
Secondary
Estrogen Level at 10 Weeks
Estrogen level (pg/mL) at 10 weeks
Time frame: 10 Weeks
Population: 23 patients in the Duloxetine group and 8 patients in the Placebo group did not have estrogen measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Estrogen Level at 10 Weeks | 31.7 pg/mL | Standard Deviation 12.2 |
| Placebo | Estrogen Level at 10 Weeks | 133 pg/mL | Standard Deviation 467 |
Secondary
Estrogen Level at 2 Weeks
Estrogen level (pg/mL) at 2 weeks
Time frame: 2 weeks
Population: 16 patients in the Duloxetine group did not have estrogen measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Estrogen Level at 2 Weeks | 53.0 pg/mL | Standard Deviation 37.6 |
| Placebo | Estrogen Level at 2 Weeks | 44.4 pg/mL | Standard Deviation 25.7 |
Secondary
Estrogen Level at 6 Weeks
Estrogen level (pg/mL) at 6 weeks
Time frame: 6 weeks
Population: 16 patients in the Duloxetine group and 5 patients in the Placebo group did not have estrogen measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Estrogen Level at 6 Weeks | 45.8 pg/mL | Standard Deviation 30.7 |
| Placebo | Estrogen Level at 6 Weeks | 43.5 pg/mL | Standard Deviation 28.2 |
Secondary
Estrogen Level at 8 Weeks
Estrogen level (pg/mL) at 8 weeks
Time frame: 8 weeks
Population: 17 patients in the Duloxetine group and 6 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Estrogen Level at 8 Weeks | 49.3 pg/mL | Standard Deviation 31.9 |
| Placebo | Estrogen Level at 8 Weeks | 39.0 pg/mL | Standard Deviation 24.8 |
Secondary
Follicle Stimulating Hormone Level at 0 Weeks
Follicle stimulating hormone level (mIU/mL) at 0 weeks
Time frame: 0 weeks
Population: 5 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Follicle Stimulating Hormone Level at 0 Weeks | 6.56 mIU/mL | Standard Deviation 12.3 |
| Placebo | Follicle Stimulating Hormone Level at 0 Weeks | 5.26 mIU/mL | Standard Deviation 4.3 |
Secondary
Follicle Stimulating Hormone Level at 10 Weeks
Follicle stimulating hormone level (mIU/mL) at 10 weeks
Time frame: 10 Weeks
Population: 23 patients in the Duloxetine group and 6 patients in the Placebo group did not have FSH measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Follicle Stimulating Hormone Level at 10 Weeks | 5.54 mIU/mL | Standard Deviation 5.44 |
| Placebo | Follicle Stimulating Hormone Level at 10 Weeks | 5.95 mIU/mL | Standard Deviation 5.43 |
Secondary
Follicle Stimulating Hormone Level at 2 Weeks
Follicle stimulating hormone level (mIU/mL) at 2 weeks
Time frame: 2 weeks
Population: 9 patients in the Duloxetine group and 1 patient in the Placebo group did not have FSH measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Follicle Stimulating Hormone Level at 2 Weeks | 5.56 mIU/mL | Standard Deviation 5.86 |
| Placebo | Follicle Stimulating Hormone Level at 2 Weeks | 5.30 mIU/mL | Standard Deviation 4.27 |
Secondary
Follicle Stimulating Hormone Level at 6 Weeks
Follicle stimulating hormone level (mIU/mL) at 6 weeks
Time frame: 6 weeks
Population: 16 patients in the Duloxetine group and 2 patients in the Placebo group did not have FSH measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Follicle Stimulating Hormone Level at 6 Weeks | 4.57 mIU/mL | Standard Deviation 5.71 |
| Placebo | Follicle Stimulating Hormone Level at 6 Weeks | 5.14 mIU/mL | Standard Deviation 4.39 |
Secondary
Follicle Stimulating Hormone Level at 8 Weeks
Follicle stimulating hormone level (mIU/mL) at 8 weeks
Time frame: 8 weeks
Population: 15 patients in the Duloxetine group and 4 patients in the Placebo group did not have FSH measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Follicle Stimulating Hormone Level at 8 Weeks | 4.18 mIU/mL | Standard Deviation 3.97 |
| Placebo | Follicle Stimulating Hormone Level at 8 Weeks | 5.29 mIU/mL | Standard Deviation 3.71 |
Secondary
Luteinizing Hormone Level at 0 Weeks
Luteinizing hormone level (mIU/mL) at 0 weeks
Time frame: 0 weeks
Population: 3 patients in the Duloxetine group did not have LH measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Luteinizing Hormone Level at 0 Weeks | 4.11 mIU/mL | Standard Deviation 4.98 |
| Placebo | Luteinizing Hormone Level at 0 Weeks | 3.37 mIU/mL | Standard Deviation 1.72 |
Secondary
Luteinizing Hormone Level at 10 Weeks
Luteinizing hormone level (mIU/mL) at 10 weeks
Time frame: 10 Weeks
Population: 22 patients in the Duloxetine group and 5 patients in the Placebo group did not have LH measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Luteinizing Hormone Level at 10 Weeks | 4.98 mIU/mL | Standard Deviation 6.4 |
| Placebo | Luteinizing Hormone Level at 10 Weeks | 3.78 mIU/mL | Standard Deviation 1.48 |
Secondary
Luteinizing Hormone Level at 2 Weeks
Luteinizing hormone level (mIU/mL) at 2 weeks
Time frame: 2 weeks
Population: 8 patients in the Duloxetine group did not have LH measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Luteinizing Hormone Level at 2 Weeks | 4.00 mIU/mL | Standard Deviation 5.47 |
| Placebo | Luteinizing Hormone Level at 2 Weeks | 3.57 mIU/mL | Standard Deviation 1.55 |
Secondary
Luteinizing Hormone Level at 6 Weeks
Luteinizing hormone level (mIU/mL) at 6 weeks
Time frame: 6 weeks
Population: 11 patients in the Duloxetine group and 1 patient in the Placebo group did not have LH measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Luteinizing Hormone Level at 6 Weeks | 4.51 mIU/mL | Standard Deviation 5.92 |
| Placebo | Luteinizing Hormone Level at 6 Weeks | 3.42 mIU/mL | Standard Deviation 1.43 |
Secondary
Luteinizing Hormone Level at 8 Weeks
Luteinizing hormone level (mIU/mL) at 8 weeks
Time frame: 8 weeks
Population: 13 patients in the Duloxetine group and 2 patients in the Placebo group did not have LH measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Luteinizing Hormone Level at 8 Weeks | 4.18 mIU/mL | Standard Deviation 5.5 |
| Placebo | Luteinizing Hormone Level at 8 Weeks | 3.70 mIU/mL | Standard Deviation 1.42 |
Secondary
Prolactin Level at 0 Weeks
Prolactin level (ng/mL) at 0 weeks
Time frame: 0 weeks
Population: 3 patients in the Duloxetine group did not have prolactin measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Prolactin Level at 0 Weeks | 11.9 ng/mL | Standard Deviation 5.78 |
| Placebo | Prolactin Level at 0 Weeks | 12.4 ng/mL | Standard Deviation 4.85 |
Secondary
Prolactin Level at 10 Weeks
Prolactin level (ng/mL) at 10 weeks
Time frame: 10 Weeks
Population: 20 patients in the Duloxetine group and 5 patients in the Placebo group did not have prolactin measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Prolactin Level at 10 Weeks | 8.83 ng/mL | Standard Deviation 3.31 |
| Placebo | Prolactin Level at 10 Weeks | 11.6 ng/mL | Standard Deviation 6.14 |
Secondary
Prolactin Level at 2 Weeks
Prolactin level (ng/mL) at 2 weeks
Time frame: 2 weeks
Population: 8 patients in the Duloxetine group did not have prolactin measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Prolactin Level at 2 Weeks | 9.74 ng/dL | Standard Deviation 3.69 |
| Placebo | Prolactin Level at 2 Weeks | 11.3 ng/dL | Standard Deviation 6.01 |
Secondary
Prolactin Level at 6 Weeks
Prolactin level (ng/mL) at 6 weeks
Time frame: 6 weeks
Population: 11 patients in the Duloxetine group and 1 patient in the Placebo group did not have prolactin measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Prolactin Level at 6 Weeks | 10.3 ng/mL | Standard Deviation 5.05 |
| Placebo | Prolactin Level at 6 Weeks | 9.60 ng/mL | Standard Deviation 6.01 |
Secondary
Prolactin Level at 8 Weeks
Prolactin level (ng/mL) at 8 weeks
Time frame: 8 weeks
Population: 12 patients in the Duloxetine group and 2 patients in the Placebo group did not have prolactin measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Prolactin Level at 8 Weeks | 10.1 ng/mL | Standard Deviation 4.91 |
| Placebo | Prolactin Level at 8 Weeks | 8.98 ng/mL | Standard Deviation 3.66 |
Secondary
Sperm Concentration at 0 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks
Time frame: 0 weeks
Population: 3 patients in the Duloxetine group did not have sperm concentration measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Concentration at 0 Weeks | 57.4 Number of sperm/mL | Standard Deviation 40.3 |
| Placebo | Sperm Concentration at 0 Weeks | 50.2 Number of sperm/mL | Standard Deviation 33.4 |
Secondary
Sperm Concentration at 10 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks
Time frame: 10 Weeks
Population: 16 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Concentration at 10 Weeks | 42.0 Number of sperm/mL | Standard Deviation 26.3 |
| Placebo | Sperm Concentration at 10 Weeks | 42.7 Number of sperm/mL | Standard Deviation 26 |
Secondary
Sperm Concentration at 2 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks
Time frame: 2 weeks
Population: 10 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Concentration at 2 Weeks | 48.9 Number of sperm/mL | Standard Deviation 38.7 |
| Placebo | Sperm Concentration at 2 Weeks | 50.0 Number of sperm/mL | Standard Deviation 41.4 |
Secondary
Sperm Concentration at 6 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks
Time frame: 6 weeks
Population: 11 patients in the Duloxetine group and 5 patients in the Placebo group did not have sperm concentration measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Concentration at 6 Weeks | 44.6 Number of sperm/mL | Standard Deviation 24.2 |
| Placebo | Sperm Concentration at 6 Weeks | 43.9 Number of sperm/mL | Standard Deviation 32.5 |
Secondary
Sperm Concentration at 8 Weeks
Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks
Time frame: 8 weeks
Population: 14 patients in the Duloxetine group and 2 patients in the Placebo group did not have sperm concentration measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Concentration at 8 Weeks | 45.7 Number of sperm/mL | Standard Deviation 29.8 |
| Placebo | Sperm Concentration at 8 Weeks | 47.1 Number of sperm/mL | Standard Deviation 28.7 |
Secondary
Sperm Head Defects at 0 Weeks
Sperm head defects (mean number) at 0 weeks
Time frame: 0 weeks
Population: 3 patients in the Duloxetine group did not have head defects measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Head Defects at 0 Weeks | 88.4 defects | Standard Deviation 16 |
| Placebo | Sperm Head Defects at 0 Weeks | 89.9 defects | Standard Deviation 8.11 |
Secondary
Sperm Head Defects at 10 Weeks
Sperm head defects (mean number) at 10 weeks
Time frame: 10 Weeks
Population: 15 patients in the Duloxetine group and 3 patients in the Placebo group did not have head defects measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Head Defects at 10 Weeks | 90.8 defects | Standard Deviation 5.65 |
| Placebo | Sperm Head Defects at 10 Weeks | 88.3 defects | Standard Deviation 16.6 |
Secondary
Sperm Head Defects at 2 Weeks
Sperm head defects (mean number) at 2 weeks
Time frame: 2 weeks
Population: 11 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Head Defects at 2 Weeks | 91.5 defects | Standard Deviation 4.02 |
| Placebo | Sperm Head Defects at 2 Weeks | 90.7 defects | Standard Deviation 7.86 |
Secondary
Sperm Head Defects at 6 Weeks
Sperm head defects (mean number) at 6 weeks
Time frame: 6 weeks
Population: 11 patients in the Duloxetine group and 5 patients in the Placebo group did not have head defects measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Head Defects at 6 Weeks | 91.6 defects | Standard Deviation 4.38 |
| Placebo | Sperm Head Defects at 6 Weeks | 91.3 defects | Standard Deviation 10.1 |
Secondary
Sperm Head Defects at 8 Weeks
Sperm head defects (mean number) at 8 weeks
Time frame: 8 weeks
Population: 13 patients in the Duloxetine group and 2 patients in the Placebo group did not have head defects measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Head Defects at 8 Weeks | 92.3 defects | Standard Deviation 4.54 |
| Placebo | Sperm Head Defects at 8 Weeks | 88.7 defects | Standard Deviation 15.1 |
Secondary
Sperm Motility at 0 Weeks
Sperm motility (mean percent) at 0 weeks
Time frame: 0 weeks
Population: 3 patients in the Duloxetine group did not have motility measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Motility at 0 Weeks | 61.7 percent motility | Standard Deviation 9.5 |
| Placebo | Sperm Motility at 0 Weeks | 59.7 percent motility | Standard Deviation 11.4 |
Secondary
Sperm Motility at 10 Weeks
Sperm motility (mean percent) at 10 weeks
Time frame: 10 Weeks
Population: 15 patients in the Duloxetine group and 3 patients in the Placebo group did not have motility measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Motility at 10 Weeks | 54.4 percent motility | Standard Deviation 17.4 |
| Placebo | Sperm Motility at 10 Weeks | 53.9 percent motility | Standard Deviation 19.7 |
Secondary
Sperm Motility at 2 Weeks
Sperm motility (mean percent) at 2 weeks
Time frame: 2 weeks
Population: 11 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Motility at 2 Weeks | 54.3 percent motility | Standard Deviation 13.3 |
| Placebo | Sperm Motility at 2 Weeks | 55.2 percent motility | Standard Deviation 13.4 |
Secondary
Sperm Motility at 6 Weeks
Sperm motility (mean percent) at 6 weeks
Time frame: 6 weeks
Population: 11 patients in the Duloxetine group and 5 patients in the Placebo group did not have motility measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Motility at 6 Weeks | 57.2 percent motility | Standard Deviation 11.2 |
| Placebo | Sperm Motility at 6 Weeks | 50.4 percent motility | Standard Deviation 20.6 |
Secondary
Sperm Motility at 8 Weeks
Sperm motility (mean percent) at 8 weeks
Time frame: 8 weeks
Population: 13 patients in the Duloxetine group and 2 patients in the Placebo group did not have motility measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Motility at 8 Weeks | 51.1 percent motility | Standard Deviation 18.6 |
| Placebo | Sperm Motility at 8 Weeks | 58.5 percent motility | Standard Deviation 12.1 |
Secondary
Sperm Neck Defects at 0 Weeks
Sperm neck defects (mean number) at 0 weeks
Time frame: 0 weeks
Population: 3 patients in the Duloxetine group did not have neck defects measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Neck Defects at 0 Weeks | 1.36 defects | Standard Deviation 2.97 |
| Placebo | Sperm Neck Defects at 0 Weeks | 2.55 defects | Standard Deviation 4.47 |
Secondary
Sperm Neck Defects at 10 Weeks
Sperm neck defects (mean number) at 10 weeks
Time frame: 10 Weeks
Population: 15 patients in the Duloxetine group and 3 patients in the Placebo group did not have neck defects measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Neck Defects at 10 Weeks | 0.91 defects | Standard Deviation 2.72 |
| Placebo | Sperm Neck Defects at 10 Weeks | 1.55 defects | Standard Deviation 3.93 |
Secondary
Sperm Neck Defects at 2 Weeks
Sperm neck defects (mean number) at 2 weeks
Time frame: 2 weeks
Population: 11 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Neck Defects at 2 Weeks | 2.65 defects | Standard Deviation 5.83 |
| Placebo | Sperm Neck Defects at 2 Weeks | 1.00 defects | Standard Deviation 3.04 |
Secondary
Sperm Neck Defects at 6 Weeks
Sperm neck defects (mean number) at 6 weeks
Time frame: 6 weeks
Population: 11 patients in the Duloxetine group and 11 patients in the Placebo group did not have neck defects measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Neck Defects at 6 Weeks | 1.12 defects | Standard Deviation 4.35 |
| Placebo | Sperm Neck Defects at 6 Weeks | 0.62 defects | Standard Deviation 1.96 |
Secondary
Sperm Neck Defects at 8 Weeks
Sperm neck defects (mean number) at 8 weeks
Time frame: 8 weeks
Population: 14 patients in the Duloxetine group and 2 patients in the Placebo group did not have neck defects measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Neck Defects at 8 Weeks | 1.17 defects | Standard Deviation 2.66 |
| Placebo | Sperm Neck Defects at 8 Weeks | 0.50 defects | Standard Deviation 1.61 |
Secondary
Sperm Tail Defects at 0 Weeks
Sperm tail defects (mean number) at 0 weeks
Time frame: 0 weeks
Population: 6 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Tail Defects at 0 Weeks | 0.13 defects | Standard Deviation 0.72 |
| Placebo | Sperm Tail Defects at 0 Weeks | 1.89 defects | Standard Deviation 7.86 |
Secondary
Sperm Tail Defects at 10 Weeks
Sperm tail defects (mean number) at 10 weeks
Time frame: 10 Weeks
Population: 15 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Tail Defects at 10 Weeks | 1.09 defects | Standard Deviation 5.12 |
| Placebo | Sperm Tail Defects at 10 Weeks | 0.96 defects | Standard Deviation 3.67 |
Secondary
Sperm Tail Defects at 2 Weeks
Sperm tail defects (mean number) at 2 weeks
Time frame: 2 weeks
Population: 16 patients in the Duloxetine group and 3 patients in the Placebo group did not have tail defects measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Tail Defects at 2 Weeks | 0.00 defects | Standard Deviation 0 |
| Placebo | Sperm Tail Defects at 2 Weeks | 1.66 defects | Standard Deviation 7.52 |
Secondary
Sperm Tail Defects at 6 Weeks
Sperm tail defects (mean number) at 6 weeks
Time frame: 6 weeks
Population: 11 patients in the Duloxetine group and 7 patients in the Placebo group did not have tail defects measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Tail Defects at 6 Weeks | 0.04 defects | Standard Deviation 0.2 |
| Placebo | Sperm Tail Defects at 6 Weeks | 2.64 defects | Standard Deviation 11 |
Secondary
Sperm Tail Defects at 8 Weeks
Sperm tail defects (mean number) at 8 weeks
Time frame: 8 weeks
Population: 14 patients in the Duloxetine group and 4 patients in the Placebo group did not have tail defects measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Sperm Tail Defects at 8 Weeks | 0.35 defects | Standard Deviation 1.3 |
| Placebo | Sperm Tail Defects at 8 Weeks | 1.25 defects | Standard Deviation 3.74 |
Secondary
Testosterone Level at 0 Weeks
Testosterone level (ng/dL) at 0 weeks
Time frame: 0 weeks
Population: 3 patients in the Duloxetine group did not have testosterone measured at 0 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Testosterone Level at 0 Weeks | 464 ng/dL | Standard Deviation 165 |
| Placebo | Testosterone Level at 0 Weeks | 448 ng/dL | Standard Deviation 160 |
Secondary
Testosterone Level at 10 Weeks
Testosterone level (ng/dL) at 10 weeks
Time frame: 10 Weeks
Population: 21 patients in the Duloxetine group and 8 patients in the Placebo group did not have testosterone measured at 10 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Testosterone Level at 10 Weeks | 445 ng/dL | Standard Deviation 165 |
| Placebo | Testosterone Level at 10 Weeks | 509 ng/dL | Standard Deviation 167 |
Secondary
Testosterone Level at 2 Weeks
Testosterone level (ng/dL) at 2 weeks
Time frame: 2 weeks
Population: 8 patients in the Duloxetine group did not have testosterone measured at 2 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Testosterone Level at 2 Weeks | 431 ng/dL | Standard Deviation 126 |
| Placebo | Testosterone Level at 2 Weeks | 482 ng/dL | Standard Deviation 171 |
Secondary
Testosterone Level at 6 Weeks
Testosterone level (ng/dL) at 6 weeks
Time frame: 6 weeks
Population: 12 patients in the Duloxetine group and 2 patients in the Placebo group did not have testosterone measured at 6 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Testosterone Level at 6 Weeks | 485 ng/dL | Standard Deviation 170 |
| Placebo | Testosterone Level at 6 Weeks | 438 ng/dL | Standard Deviation 174 |
Secondary
Testosterone Level at 8 Weeks
Testosterone level (ng/dL) at 8 weeks
Time frame: 8 weeks
Population: 12 patients in the Duloxetine group and 4 patients in the Placebo group did not have testosterone measured at 8 weeks (patients were not available).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Duloxetine | Testosterone Level at 8 Weeks | 534 ng/dL | Standard Deviation 237 |
| Placebo | Testosterone Level at 8 Weeks | 460 ng/dL | Standard Deviation 144 |