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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine | Experimental | Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Sperm Concentration at 0 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks | 0 weeks |
| Sperm Concentration at 2 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Schlegel, MD | Weill Medical College of Cornell University | Study Chair |
| Nahid Punjani, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | New York | New York | 10065 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Placebo | Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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). | Posted | Count of Participants | Participants | 6 Weeks (primary time point of interest) |
|
1 year, 4 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research coordinator | Weill Cornell Medical College | 212-746-5385 | mac4015@med.cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 25, 2016 | Jan 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| D003863 | Depression |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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Blinded, placebo-controlled, randomized controlled trial
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Participant, investigator, and outcomes assessor are all blinded to participant's assigned group.
| Placebo | Drug | Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week |
|
| 2 weeks |
| Sperm Concentration at 6 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks | 6 weeks |
| Sperm Concentration at 8 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks | 8 weeks |
| Sperm Concentration at 10 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks | 10 Weeks |
| Sperm Motility at 0 Weeks | Sperm motility (mean percent) at 0 weeks | 0 weeks |
| Sperm Motility at 2 Weeks | Sperm motility (mean percent) at 2 weeks | 2 weeks |
| Sperm Motility at 6 Weeks | Sperm motility (mean percent) at 6 weeks | 6 weeks |
| Sperm Motility at 8 Weeks | Sperm motility (mean percent) at 8 weeks | 8 weeks |
| Sperm Motility at 10 Weeks | Sperm motility (mean percent) at 10 weeks | 10 Weeks |
| Sperm Head Defects at 0 Weeks | Sperm head defects (mean number) at 0 weeks | 0 weeks |
| Sperm Head Defects at 2 Weeks | Sperm head defects (mean number) at 2 weeks | 2 weeks |
| Sperm Head Defects at 6 Weeks | Sperm head defects (mean number) at 6 weeks | 6 weeks |
| Sperm Head Defects at 8 Weeks | Sperm head defects (mean number) at 8 weeks | 8 weeks |
| Sperm Head Defects at 10 Weeks | Sperm head defects (mean number) at 10 weeks | 10 Weeks |
| Sperm Neck Defects at 0 Weeks | Sperm neck defects (mean number) at 0 weeks | 0 weeks |
| Sperm Neck Defects at 2 Weeks | Sperm neck defects (mean number) at 2 weeks | 2 weeks |
| Sperm Neck Defects at 6 Weeks | Sperm neck defects (mean number) at 6 weeks | 6 weeks |
| Sperm Neck Defects at 8 Weeks | Sperm neck defects (mean number) at 8 weeks | 8 weeks |
| Sperm Neck Defects at 10 Weeks | Sperm neck defects (mean number) at 10 weeks | 10 Weeks |
| Sperm Tail Defects at 0 Weeks | Sperm tail defects (mean number) at 0 weeks | 0 weeks |
| Sperm Tail Defects at 2 Weeks | Sperm tail defects (mean number) at 2 weeks | 2 weeks |
| Sperm Tail Defects at 6 Weeks | Sperm tail defects (mean number) at 6 weeks | 6 weeks |
| Sperm Tail Defects at 8 Weeks | Sperm tail defects (mean number) at 8 weeks | 8 weeks |
| Sperm Tail Defects at 10 Weeks | Sperm tail defects (mean number) at 10 weeks | 10 Weeks |
| Testosterone Level at 0 Weeks | Testosterone level (ng/dL) at 0 weeks | 0 weeks |
| Testosterone Level at 2 Weeks | Testosterone level (ng/dL) at 2 weeks | 2 weeks |
| Testosterone Level at 6 Weeks | Testosterone level (ng/dL) at 6 weeks | 6 weeks |
| Testosterone Level at 8 Weeks | Testosterone level (ng/dL) at 8 weeks | 8 weeks |
| Testosterone Level at 10 Weeks | Testosterone level (ng/dL) at 10 weeks | 10 Weeks |
| Estrogen Level at 0 Weeks | Estrogen level (pg/mL) at 0 weeks | 0 weeks |
| Estrogen Level at 2 Weeks | Estrogen level (pg/mL) at 2 weeks | 2 weeks |
| Estrogen Level at 6 Weeks | Estrogen level (pg/mL) at 6 weeks | 6 weeks |
| Estrogen Level at 8 Weeks | Estrogen level (pg/mL) at 8 weeks | 8 weeks |
| Estrogen Level at 10 Weeks | Estrogen level (pg/mL) at 10 weeks | 10 Weeks |
| Prolactin Level at 0 Weeks | Prolactin level (ng/mL) at 0 weeks | 0 weeks |
| Prolactin Level at 2 Weeks | Prolactin level (ng/mL) at 2 weeks | 2 weeks |
| Prolactin Level at 6 Weeks | Prolactin level (ng/mL) at 6 weeks | 6 weeks |
| Prolactin Level at 8 Weeks | Prolactin level (ng/mL) at 8 weeks | 8 weeks |
| Prolactin Level at 10 Weeks | Prolactin level (ng/mL) at 10 weeks | 10 Weeks |
| Luteinizing Hormone Level at 0 Weeks | Luteinizing hormone level (mIU/mL) at 0 weeks | 0 weeks |
| Luteinizing Hormone Level at 2 Weeks | Luteinizing hormone level (mIU/mL) at 2 weeks | 2 weeks |
| Luteinizing Hormone Level at 6 Weeks | Luteinizing hormone level (mIU/mL) at 6 weeks | 6 weeks |
| Luteinizing Hormone Level at 8 Weeks | Luteinizing hormone level (mIU/mL) at 8 weeks | 8 weeks |
| Luteinizing Hormone Level at 10 Weeks | Luteinizing hormone level (mIU/mL) at 10 weeks | 10 Weeks |
| Follicle Stimulating Hormone Level at 0 Weeks | Follicle stimulating hormone level (mIU/mL) at 0 weeks | 0 weeks |
| Follicle Stimulating Hormone Level at 2 Weeks | Follicle stimulating hormone level (mIU/mL) at 2 weeks | 2 weeks |
| Follicle Stimulating Hormone Level at 6 Weeks | Follicle stimulating hormone level (mIU/mL) at 6 weeks | 6 weeks |
| Follicle Stimulating Hormone Level at 8 Weeks | Follicle stimulating hormone level (mIU/mL) at 8 weeks | 8 weeks |
| Follicle Stimulating Hormone Level at 10 Weeks | Follicle stimulating hormone level (mIU/mL) at 10 weeks | 10 Weeks |
Placebo
Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
| 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 | 5 patients in the Duloxetine group did not have Tunel data measured at 0 weeks (patients were not available) | Posted | Count of Participants | Participants | 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 | 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). | Posted | Count of Participants | Participants | 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 | 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). | Posted | Count of Participants | Participants | 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 | 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). | Posted | Count of Participants | Participants | 10 Weeks |
|
|
|
| Secondary | Sperm Concentration at 0 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 0 weeks | 3 patients in the Duloxetine group did not have sperm concentration measured at 0 weeks (patients were not available). | Posted | Mean | Standard Deviation | Number of sperm/mL | 0 weeks |
|
|
|
| Secondary | Sperm Concentration at 2 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 2 weeks | 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). | Posted | Mean | Standard Deviation | Number of sperm/mL | 2 weeks |
|
|
|
| Secondary | Sperm Concentration at 6 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 6 weeks | 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). | Posted | Mean | Standard Deviation | Number of sperm/mL | 6 weeks |
|
|
|
| Secondary | Sperm Concentration at 8 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 8 weeks | 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). | Posted | Mean | Standard Deviation | Number of sperm/mL | 8 weeks |
|
|
|
| Secondary | Sperm Concentration at 10 Weeks | Sperm concentration (number of sperm/mL) in semen analysis at 10 weeks | 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). | Posted | Mean | Standard Deviation | Number of sperm/mL | 10 Weeks |
|
|
|
| Secondary | Sperm Motility at 0 Weeks | Sperm motility (mean percent) at 0 weeks | 3 patients in the Duloxetine group did not have motility measured at 0 weeks (patients were not available). | Posted | Mean | Standard Deviation | percent motility | 0 weeks |
|
|
|
| Secondary | Sperm Motility at 2 Weeks | Sperm motility (mean percent) at 2 weeks | 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). | Posted | Mean | Standard Deviation | percent motility | 2 weeks |
|
|
|
| Secondary | Sperm Motility at 6 Weeks | Sperm motility (mean percent) at 6 weeks | 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). | Posted | Mean | Standard Deviation | percent motility | 6 weeks |
|
|
|
| Secondary | Sperm Motility at 8 Weeks | Sperm motility (mean percent) at 8 weeks | 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). | Posted | Mean | Standard Deviation | percent motility | 8 weeks |
|
|
|
| Secondary | Sperm Motility at 10 Weeks | Sperm motility (mean percent) at 10 weeks | 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). | Posted | Mean | Standard Deviation | percent motility | 10 Weeks |
|
|
|
| Secondary | Sperm Head Defects at 0 Weeks | Sperm head defects (mean number) at 0 weeks | 3 patients in the Duloxetine group did not have head defects measured at 0 weeks (patients were not available). | Posted | Mean | Standard Deviation | defects | 0 weeks |
|
|
|
| Secondary | Sperm Head Defects at 2 Weeks | Sperm head defects (mean number) at 2 weeks | 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). | Posted | Mean | Standard Deviation | defects | 2 weeks |
|
|
|
| Secondary | Sperm Head Defects at 6 Weeks | Sperm head defects (mean number) at 6 weeks | 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). | Posted | Mean | Standard Deviation | defects | 6 weeks |
|
|
|
| Secondary | Sperm Head Defects at 8 Weeks | Sperm head defects (mean number) at 8 weeks | 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). | Posted | Mean | Standard Deviation | defects | 8 weeks |
|
|
|
| Secondary | Sperm Head Defects at 10 Weeks | Sperm head defects (mean number) at 10 weeks | 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). | Posted | Mean | Standard Deviation | defects | 10 Weeks |
|
|
|
| Secondary | Sperm Neck Defects at 0 Weeks | Sperm neck defects (mean number) at 0 weeks | 3 patients in the Duloxetine group did not have neck defects measured at 0 weeks (patients were not available). | Posted | Mean | Standard Deviation | defects | 0 weeks |
|
|
|
| Secondary | Sperm Neck Defects at 2 Weeks | Sperm neck defects (mean number) at 2 weeks | 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). | Posted | Mean | Standard Deviation | defects | 2 weeks |
|
|
|
| Secondary | Sperm Neck Defects at 6 Weeks | Sperm neck defects (mean number) at 6 weeks | 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). | Posted | Mean | Standard Deviation | defects | 6 weeks |
|
|
|
| Secondary | Sperm Neck Defects at 8 Weeks | Sperm neck defects (mean number) at 8 weeks | 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). | Posted | Mean | Standard Deviation | defects | 8 weeks |
|
|
|
| Secondary | Sperm Neck Defects at 10 Weeks | Sperm neck defects (mean number) at 10 weeks | 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). | Posted | Mean | Standard Deviation | defects | 10 Weeks |
|
|
|
| Secondary | Sperm Tail Defects at 0 Weeks | Sperm tail defects (mean number) at 0 weeks | 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). | Posted | Mean | Standard Deviation | defects | 0 weeks |
|
|
|
| Secondary | Sperm Tail Defects at 2 Weeks | Sperm tail defects (mean number) at 2 weeks | 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). | Posted | Mean | Standard Deviation | defects | 2 weeks |
|
|
|
| Secondary | Sperm Tail Defects at 6 Weeks | Sperm tail defects (mean number) at 6 weeks | 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). | Posted | Mean | Standard Deviation | defects | 6 weeks |
|
|
|
| Secondary | Sperm Tail Defects at 8 Weeks | Sperm tail defects (mean number) at 8 weeks | 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). | Posted | Mean | Standard Deviation | defects | 8 weeks |
|
|
|
| Secondary | Sperm Tail Defects at 10 Weeks | Sperm tail defects (mean number) at 10 weeks | 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). | Posted | Mean | Standard Deviation | defects | 10 Weeks |
|
|
|
| Secondary | Testosterone Level at 0 Weeks | Testosterone level (ng/dL) at 0 weeks | 3 patients in the Duloxetine group did not have testosterone measured at 0 weeks (patients were not available). | Posted | Mean | Standard Deviation | ng/dL | 0 weeks |
|
|
|
| Secondary | Testosterone Level at 2 Weeks | Testosterone level (ng/dL) at 2 weeks | 8 patients in the Duloxetine group did not have testosterone measured at 2 weeks (patients were not available). | Posted | Mean | Standard Deviation | ng/dL | 2 weeks |
|
|
|
| Secondary | Testosterone Level at 6 Weeks | Testosterone level (ng/dL) at 6 weeks | 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). | Posted | Mean | Standard Deviation | ng/dL | 6 weeks |
|
|
|
| Secondary | Testosterone Level at 8 Weeks | Testosterone level (ng/dL) at 8 weeks | 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). | Posted | Mean | Standard Deviation | ng/dL | 8 weeks |
|
|
|
| Secondary | Testosterone Level at 10 Weeks | Testosterone level (ng/dL) at 10 weeks | 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). | Posted | Mean | Standard Deviation | ng/dL | 10 Weeks |
|
|
|
| Secondary | Estrogen Level at 0 Weeks | Estrogen level (pg/mL) at 0 weeks | 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). | Posted | Mean | Standard Deviation | pg/mL | 0 weeks |
|
|
|
| Secondary | Estrogen Level at 2 Weeks | Estrogen level (pg/mL) at 2 weeks | 16 patients in the Duloxetine group did not have estrogen measured at 2 weeks (patients were not available). | Posted | Mean | Standard Deviation | pg/mL | 2 weeks |
|
|
|
| Secondary | Estrogen Level at 6 Weeks | Estrogen level (pg/mL) at 6 weeks | 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). | Posted | Mean | Standard Deviation | pg/mL | 6 weeks |
|
|
|
| Secondary | Estrogen Level at 8 Weeks | Estrogen level (pg/mL) at 8 weeks | 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). | Posted | Mean | Standard Deviation | pg/mL | 8 weeks |
|
|
|
| Secondary | Estrogen Level at 10 Weeks | Estrogen level (pg/mL) at 10 weeks | 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). | Posted | Mean | Standard Deviation | pg/mL | 10 Weeks |
|
|
|
| Secondary | Prolactin Level at 0 Weeks | Prolactin level (ng/mL) at 0 weeks | 3 patients in the Duloxetine group did not have prolactin measured at 0 weeks (patients were not available). | Posted | Mean | Standard Deviation | ng/mL | 0 weeks |
|
|
|
| Secondary | Prolactin Level at 2 Weeks | Prolactin level (ng/mL) at 2 weeks | 8 patients in the Duloxetine group did not have prolactin measured at 2 weeks (patients were not available). | Posted | Mean | Standard Deviation | ng/dL | 2 weeks |
|
|
|
| Secondary | Prolactin Level at 6 Weeks | Prolactin level (ng/mL) at 6 weeks | 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). | Posted | Mean | Standard Deviation | ng/mL | 6 weeks |
|
|
|
| Secondary | Prolactin Level at 8 Weeks | Prolactin level (ng/mL) at 8 weeks | 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). | Posted | Mean | Standard Deviation | ng/mL | 8 weeks |
|
|
|
| Secondary | Prolactin Level at 10 Weeks | Prolactin level (ng/mL) at 10 weeks | 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). | Posted | Mean | Standard Deviation | ng/mL | 10 Weeks |
|
|
|
| Secondary | Luteinizing Hormone Level at 0 Weeks | Luteinizing hormone level (mIU/mL) at 0 weeks | 3 patients in the Duloxetine group did not have LH measured at 0 weeks (patients were not available). | Posted | Mean | Standard Deviation | mIU/mL | 0 weeks |
|
|
|
| Secondary | Luteinizing Hormone Level at 2 Weeks | Luteinizing hormone level (mIU/mL) at 2 weeks | 8 patients in the Duloxetine group did not have LH measured at 2 weeks (patients were not available). | Posted | Mean | Standard Deviation | mIU/mL | 2 weeks |
|
|
|
| Secondary | Luteinizing Hormone Level at 6 Weeks | Luteinizing hormone level (mIU/mL) at 6 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 6 weeks |
|
|
|
| Secondary | Luteinizing Hormone Level at 8 Weeks | Luteinizing hormone level (mIU/mL) at 8 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 8 weeks |
|
|
|
| Secondary | Luteinizing Hormone Level at 10 Weeks | Luteinizing hormone level (mIU/mL) at 10 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 10 Weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone Level at 0 Weeks | Follicle stimulating hormone level (mIU/mL) at 0 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 0 weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone Level at 2 Weeks | Follicle stimulating hormone level (mIU/mL) at 2 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 2 weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone Level at 6 Weeks | Follicle stimulating hormone level (mIU/mL) at 6 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 6 weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone Level at 8 Weeks | Follicle stimulating hormone level (mIU/mL) at 8 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 8 weeks |
|
|
|
| Secondary | Follicle Stimulating Hormone Level at 10 Weeks | Follicle stimulating hormone level (mIU/mL) at 10 weeks | 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). | Posted | Mean | Standard Deviation | mIU/mL | 10 Weeks |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Placebo | Placebo Placebo: Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week | 0 | 32 | 0 | 32 | 0 | 32 |
Not provided
Not provided
Not provided
| D052801 |
| Male Urogenital Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D006571 |
| Heterocyclic Compounds |