Androgen Hormones in PMDD
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 115
- 主要终点
- Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
研究概览
简要总结
This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
详细描述
Premenstrual dysphoric disorder (PMDD) is a condition that affects about 5% of menstruating women. Women with PMDD experience serious emotional and physical disturbances, which may include depression, tension, irritability, anger, anxiety, and sleep and appetite problems. Symptoms of PMDD are directly linked with the menstrual cycle, generally beginning in the latter half of the cycle and ending around the start of the next cycle. If left unmanaged, PMDD may interfere with a woman's ability to carry out normal day-to-day functioning. Current treatments for PMDD include medications, psychotherapy, and nutritional modifications. Flutamide, a medication that blocks the action of testosterone and other mood-influencing hormones, may be helpful in alleviating symptoms of PMDD. This study will evaluate the effectiveness of flutamide in reducing symptoms of premenstrual dysphoric disorder.
This two-phase study will last a total of 4 months and will include 7 study visits. Phase 1 will last 2 months and will include Visits 1 through 3. During Phase 1, participants will keep a daily record of symptoms, participate in a diagnostic interview, and undergo a medical history review, a physical exam, and screening laboratory tests. Eligible participants will then enter Phase 2, the treatment phase of the study.
During the treatment phase, participants will be randomly assigned to take flutamide or placebo for 2 months. Study visits will occur every 2 weeks and will include Visits 4 through 7. These visits will include discussion of side effects, symptom rating, and laboratory tests to check for pregnancy and any side effects related to liver function, blood counts, or blood chemistry. At the end of treatment with flutamide or placebo, participants will have the option of receiving treatment with sertraline, an antidepressant known to be effective for many women with PMDD. Sertraline will be given during the 2 premenstrual weeks for two cycles. If participants have already unsuccessfully tried sertraline for PMDD treatment, an alternative treatment can be attempted.
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 48 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meets DSM-IV criteria for PMDD by history
- •Regular menstrual cycles that are 25 to 35 days in length during the year prior to study entry
- •Willing to use barrier methods of birth control during the study if sexually active
- •If engaged in psychotherapy for at least 3 months before study entry, participation will be allowed if the intensity of psychotherapy remains the same during the study
- •Normal PAP and physical exam, including pelvic exam, within the 1 year prior to study entry
排除标准
- •Use of oral contraceptives or other exogenous hormone preparations within the 3 months prior to study entry
- •Suicide attempt or severe suicidal ideation within the 2 years prior to study entry
- •History of any psychotic disorder or bipolar disorder
- •Substance abuse, except nicotine, within the 6 months prior to study entry
- •Use of pharmacological treatment for PMDD symptoms (e.g., antidepressants, hormones, gonadotropin-releasing hormone agonists, anxiolytics, calcium, herbal preparations, diuretics) within the 3 months prior to study entry
- •Daily use of psychotropic or anticonvulsant medications within the 3 months prior to study entry
- •Use of sleeping pills more than once per week
- •Consumption of more than 50 ounces of alcohol per week
- •Pregnant or breastfeeding
- •Hepatic, renal, autoimmune, or chronic inflammatory disease
- •Seizure disorder
- •Inability to read or follow instructions in English
研究组 & 干预措施
B
Participants will take placebo flutamide
干预措施: Placebo (Drug)
A
Participants will take flutamide
干预措施: Flutamide (Drug)
结局指标
主要结局
Change in Premenstrual Symptoms as Measured by the Premenstrual Tension Scale (PMTS)
时间窗: Measured at Months 1and 2
Low score on PMTS scale is 0 and high score is 40. Change score is calculated as PMTS score at month 1 or month 2 minus baseline PMTS score. Negative change score is a reduction in symptoms during treatment and positive change score is an increase in symptoms during treatment.
次要结局
- Premenstrual Symptoms as Measured by the Clinical Global Improvement Scale at Month 1 and Month 2(Measured at Months 1 and 2)
- Side Effect Burden Measured by Side Effect Questionnaire(Measured at Months 1 and 2)
- Change in Premenstrual Symptoms as Measured by the Daily Rating of Severity of Problems (DRSP) Scale(Measured at Months 1 and 2)