Effect of Serotonin Reuptake Inhibitors on Gonadal Steroid Hormones
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 83
- 主要终点
- Change in 17-OH Pregnenolone
研究概览
简要总结
This study will evaluate the effect of antidepressants on sex hormone levels in women and if the potential changes in sex hormone levels are related to sexual side effects.
详细描述
Depression is a leading cause of disability in women, with women being two times more likely than men to develop depression. Depression affects a person's body, thoughts, mood, and behavior, often making normal day-to-day functioning difficult. Fortunately, depression is a condition that is highly treatable with one or more of the antidepressant medications and forms of psychotherapy available. Serotonin reuptake inhibitors (SRIs) are a recent class of antidepressants that have been successful in alleviating symptoms of depression. Although the side effects of SRIs are less than those of other types of antidepressants, a number of people taking SRIs experience sexual dysfunction, including reduced desire and difficulty with orgasm. It is believed that SRI treatment may interfere with gonadal production of steroid hormones, thus leading to changes in sexual function. This study will compare the effects of the SRI fluoxetine with the effects of the non-SRI bupropion on circulating levels of sex hormones in healthy women and on any related sexual side effects.
Participation in this study will last 3 months. Potential participants will undergo initial screening, which will involve a blood draw, drug and pregnancy tests, physical exam, electrocardiogram, and psychiatric diagnostic interview. Participants will also complete an interview and questionnaire about sexual functioning. All eligible participants will then be asked to return for a total of 9 study visits over 3 months.
Participants will undergo 1 month of baseline hormonal sampling and 2 months of daily treatment with either fluoxetine or bupropion. The study visits will be scheduled around three points in the menstrual cycle (early follicular, ovulatory, and luteal), with each visit including a blood draw and repeat questionnaire on sexual functioning. Participants will be asked to perform daily urine tests, beginning 10 days after the start of menstruation and continuing for up to 8 days until detection of the luteinizing hormone surge, which signals ovulation. Participants will be asked to keep a diary of luteinizing hormone surges, dates of menstruation, and sexual activities. At the Month 3 visit, participants will discontinue their assigned medication and will complete their final blood draw and questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Regular menstrual cycles that are 25 to 35 days in length during the 1 year prior to study entry
- •Willing to engage in sexual activity, alone or with a partner, at least weekly for the duration of the study
- •Willing to use effective birth control (e.g., condom, diaphragm with spermicide, tubal ligation, nonhormonal intrauterine device,, partner with vasectomy) for the duration of the study
排除标准
- •Medical illness that may contribute to sexual dysfunction or affect steroid hormone levels
- •Body mass index (BMI) greater than 30
- •Elevated testosterone at screening
- •History of seizure disorder
- •Consumes more than 10 alcoholic beverages per week
研究组 & 干预措施
A
Participants will receive treatment with fluoxetine for 2 months
干预措施: Fluoxetine (Drug)
B
Participants will receive treatment with bupropion for 2 months
干预措施: Bupropion (Drug)
结局指标
主要结局
Change in 17-OH Pregnenolone
时间窗: Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles
Hormone levels at early follicular, ovulation, and luteal phase of 3 menstrual cycles which included baseline, month 1 of daily antidepressant treatment and month 2 of daily antidepressant treatment. Effects of the two antidepressant treatments and menstrual cycle on hormone level were examined.
次要结局
- Change in Dehydroepiandrosterone Sulfate (DHEA-S)(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Change in Progesterone(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Change in Estradiol(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Change in Arizona Sexual Experiences Scale (ASEX)(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Change in Androstenedione(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- C-reactive Protein(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Inflammatory Cytokines(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Lymphocyte Activation Markers(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Change in Free Testosterone(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)
- Change in Prolactin(Measured in baseline menstrual cycle and during antidepressant treatment for two menstrual cycles)