Assessing the Impact of Escitalopram on Sperm DNA Fragmentation: A Randomized Placebo Controlled
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Normal semen analyses, or semen analyses with at least 5 million sperm
- •Normal TUNEL value (<7%)
- •Willing to engage in at least weekly sexual activity, with a partner or alone for the duration of the 10-week study
排除标准
- •Azoospermia or severe oligospermia (<5million sperm per semen analysis)
- •Presently attempting to conceive pregnancy
- •Sexual dysfunction preventing ability to provide semen analysis throughout study or engage in weekly sexual activity
- •Current psychiatric disorder including: bipolar, mania, depression, generalized anxiety, social phobia, panic attacks, obsessive compulsive disorder, and schizophrenia.
- •Family history of bipolar disorder, or suicide (including 2nd degree relatives)
- •Present use of psychotropic agents (prescription or herbal) or anticonvulsants
- •Use of sleeping pills
- •Alcohol consumption greater that 2oz/day
- •Use of illicit drugs
- •Inability to read, follow instructions or complete questionnaires in English.
- •Use of hormonal medications in past 3 months (androgens, androgen blockade, anabolic steroids, estrogens, herbal)
- •Use of medications to enhance sexual function
- •History of chemotherapy or pelvic radiation
- •Use of Monoamine Oxidase inhibitors (MAOi's) or tricyclic antidepressants (TCAs) within 14 days
- •Liver disease
研究组 & 干预措施
Placebo
Matched placebo control by mouth for 6 weeks.
干预措施: Placebo (Other)
Escitalopram
10mg by mouth daily for 6 weeks
干预措施: Escitalopram (Drug)
结局指标
主要结局
Percentage of Patients Who Have Abnormal (>7%) TUNEL DNA Fragmentation Levels After 6 Weeks of Treatment
时间窗: 6 weeks
TUNEL assay for sperm DNA fragmentation,Percentage of patients who have abnormal (\>7%) TUNEL DNA fragmentation levels after 6 weeks of treatment
次要结局
- 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(0 (baseline), 6, 10 weeks)