Healthy
Conditions
Keywords
Human volunteers
Brief summary
According to the National Institute of Mental Health, depressive disorders afflict over six million U.S. men annually. Most cases of moderate or severe depression are treated with antidepressants, including monoamine oxidase inhibitors, tricyclic antidepressants, and, more recently, selective serotonin reuptake inhibitors (SSRIs) and antidepressants with modest serotonin and norepinephrine reuptake inhibition but unknown mechanism-of-action. Over the past two years, prescribing data show a steady increase in antidepressant dispensing rates (especially including serotonin reuptake inhibitors) for adults. SSRIs are known to have an effect on ejaculatory function and are therapeutically used for treatment of premature (rapid) ejaculation. However, few studies have evaluated the potential impact of antidepressant medications on male fertility, and no studies have been published with respect to the impact of newer antidepressants, such as SSRIs, on male fertility. In the high-volume male infertility practice at New York Hospital-Cornell Medical Center, several patients have presented who have had a clear temporal association between SSRI use and impairment in sperm motility and/or sperm transport (emission). These men have shown improvement in sperm counts and motility after discontinuation of antidepressant medications.
Detailed description
We propose a crossover pilot study of normal healthy males to ascertain possible effects of SSRIs on semen parameters. After initial screening semen analyses, subjects will take the SSRI paroxetine for five weeks. Serial semen analyses will be obtained while on medication and one month after discontinuation of medication. Comparisons between semen parameters on and off medication will be used to evaluate the frequency and significance of semen analysis changes during SSRI treatment.
Interventions
DRUGparoxetine
paroxetine 10-40mg daily x 5 weeks
Sponsors
Weill Medical College of Cornell University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Normal, healthy male volunteers, ages 18-65 * Must be able to swallow pills
Exclusion criteria
* Known sexual dysfunction * Tobacco use * Prescription medications * History of psychiatric disorders * Previous chemotherapy or radiation treatment * History of seizure disorder * Alcohol use greater than 2 ounces daily * Illicit drug use * Azoospermia on screening semen analysis * Varicocele * Currently attempting to achieve pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Semen Volume | 2 months post initial visit | measured in mL |
| Sperm Concentration | 2 months post initial visit | number of sperm per cubic centimeter of semen |
| Sperm Motility | 2 months post initial visit | percent of sperm with movement |
| Sperm Morphology | 2 months post initial visit | percent of sperm with normal shape |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Paroxetine Paroxetine was administered for 5 weeks using an escalating dosing schedule: week 1, 10 mg daily; week 2, 20 mg daily; weeks 3 and 4, 30 mg daily; week 5, 20 mg daily. | 35 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Paroxetine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 33 |
| serious Total, serious adverse events | 0 / 33 |
Outcome results
Primary
Semen Volume
measured in mL
Time frame: 2 months post initial visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Semen Volume | 2.55 mL | Standard Deviation 1.26 |
Primary
Sperm Concentration
number of sperm per cubic centimeter of semen
Time frame: 2 months post initial visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Sperm Concentration | 75 number of sperm per cubic centimeter | Standard Deviation 67.65 |
Primary
Sperm Morphology
percent of sperm with normal shape
Time frame: 2 months post initial visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Sperm Morphology | 20.24 percent of sperm with normal shape | Standard Deviation 8.89 |
Primary
Sperm Motility
percent of sperm with movement
Time frame: 2 months post initial visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Paroxetine | Sperm Motility | 50.21 Percent of sperm with movement | Standard Deviation 16.55 |