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funding stopped
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Double-blind placebo-controlled randomized trial of daily escitalopram for 6 weeks in healthy men with normal semen analyses and no psychiatric history of depression, bipolar, mania or suicidal ideation. Hormone profiles, semen analysis, sperm DNA fragmentation, and sexual function will be measured at baseline, after 6 weeks of therapy, and 4 weeks after discontinuation of therapy (10 weeks into study).
SSRI medications, specifically escitalopram is a very commonly prescribed medication among men of reproductive age. Significant evidence exists that they may be harmful for paternal fertility potential in both animal and human studies. However, high quality data is lacking, particularly among commonly used SSRI's such as escitalopram. As such, it is important to properly evaluate the potential effect of escitalopram in a randomized placebo controlled fashion. Results will be important in guiding urologists, psychiatrists and family practitioners regarding discussion surrounding SSRI use in their patients interested in fertility.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Escitalopram | Experimental | 10mg by mouth daily for 6 weeks |
|
| Placebo | Placebo Comparator | Matched placebo control by mouth for 6 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Escitalopram | Drug | 10mg by mouth daily for 6 weeks |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment | TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment) | Tunnel assay of the DNA fragmentation, Percentage of patients who have abnormal DNA fragmentation levels at 10 weeks (4 weeks following cessation of treatment) | 10 weeks |
| Absolute Change in DNA Fragmentation Percentage |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Testosterone Measurement | Change in serum testosterone (ng/dL) | 0 (baseline), 6, 10 weeks |
| Change in Serum Luteinizing Hormone (LH) (mIU/mL) | Serum Luteinizing hormone measurement, Change in serum luteinizing hormone (LH) (mIU/mL) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Gal, MD | Weill Medical College of Cornell University | Principal Investigator |
| Peter Schlegel, 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 | Escitalopram | 10mg by mouth daily for 6 weeks Escitalopram: 10mg by mouth daily for 6 weeks |
| FG001 | Placebo | Matched placebo control by mouth for 6 weeks. Placebo: matched placebo control by mouth for 6 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Escitalopram | 10mg by mouth daily for 6 weeks Escitalopram: 10mg by mouth daily for 6 weeks |
| BG001 | Placebo | Matched placebo control by mouth for 6 weeks. Placebo: matched placebo control by mouth for 6 weeks |
| 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 | Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment | TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment | Posted | Number | Percentage | 6 weeks |
|
10 weeks
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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 | Escitalopram | 10mg by mouth daily for 6 weeks Escitalopram: 10mg by mouth daily for 6 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Gal | Weill Cornell Medicine | 646-962-4811 | jog4018@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 | May 9, 2023 | Dec 2, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007248 | Infertility, Male |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007246 | Infertility |
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| ID | Term |
|---|---|
| D000089983 | Escitalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Other |
matched placebo control by mouth for 6 weeks |
|
Absolute change in DNA fragmentation percentage across treatment groups from baseline |
| 0 (baseline), 6, 10 weeks |
| 0 (baseline), 6, 10 weeks |
| Change in Serum Follicle-stimulating Hormone (FSH) (mIU/mL) | Serum follicle-stimulating hormone measurement,Change in serum follicle-stimulating hormone (FSH) (mIU/mL) | 0 (baseline), 6, 10 weeks |
| Change in Serum Prolactin (ng/mL) | serum prolactin measurement,Change in serum prolactin (ng/mL) | 0 (baseline), 6, 10 weeks |
| Change in International Index of Erectile Function Survey | International Index of Erectile Function (IIEF) Survey. Severe Erectile Dysfunction (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no Erectile Dysfunction (22-25) | 0 (Baseline), 6, 10 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Percentage of Patients Who Have Abnormal DNA Fragmentation Levels at 10 Weeks (4 Weeks Following Cessation of Treatment) | Tunnel assay of the DNA fragmentation, Percentage of patients who have abnormal DNA fragmentation levels at 10 weeks (4 weeks following cessation of treatment) | Posted | Number | participants | 10 weeks |
|
|
|
| Secondary | Absolute Change in DNA Fragmentation Percentage | Absolute change in DNA fragmentation percentage across treatment groups from baseline | Posted | Mean | Standard Deviation | Percentage | 0 (baseline), 6, 10 weeks |
|
|
|
| Other Pre-specified | Serum Testosterone Measurement | Change in serum testosterone (ng/dL) | Not Posted | 0 (baseline), 6, 10 weeks | Participants |
| Other Pre-specified | Change in Serum Luteinizing Hormone (LH) (mIU/mL) | Serum Luteinizing hormone measurement, Change in serum luteinizing hormone (LH) (mIU/mL) | Not Posted | 0 (baseline), 6, 10 weeks | Participants |
| Other Pre-specified | Change in Serum Follicle-stimulating Hormone (FSH) (mIU/mL) | Serum follicle-stimulating hormone measurement,Change in serum follicle-stimulating hormone (FSH) (mIU/mL) | Not Posted | 0 (baseline), 6, 10 weeks | Participants |
| Other Pre-specified | Change in Serum Prolactin (ng/mL) | serum prolactin measurement,Change in serum prolactin (ng/mL) | Not Posted | 0 (baseline), 6, 10 weeks | Participants |
| Other Pre-specified | Change in International Index of Erectile Function Survey | International Index of Erectile Function (IIEF) Survey. Severe Erectile Dysfunction (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no Erectile Dysfunction (22-25) | Not Posted | 0 (Baseline), 6, 10 weeks | Participants |
| 0 |
| 37 |
| 0 |
| 37 |
| 0 |
| 37 |
| EG001 | Placebo | Matched placebo control by mouth for 6 weeks. Placebo: matched placebo control by mouth for 6 weeks | 0 | 38 | 0 | 38 | 0 | 38 |
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| D052801 |
| Male Urogenital Diseases |
| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| 10 Weeks |
|