EUCTR2004-005173-27-DE进行中（未招募）不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF A COMBINATION OF LEVONORGESTREL AND ETHINYL ESTRADIOL IN A CONTINUOUS DAILY REGIMEN IN SUBJECTS WITH PREMENSTRUAL DYSPHORIC DISORDER
Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development0 个研究点目标入组 90 人开始时间: 2006年6月2日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 90
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.Generally healthy women aged 18 to 49 years who meet Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV), criteria for PMDD and who are willing to take a combination OC.
- •2.Subjects must have symptoms consistent with PMDD by history over the past year.
- •3.Subjects must prospectively meet the following criteria using the DRSP instrument and worksheet : a.Subjects must have an average (across 5 days) daily follicular phase (days 8 to 12 after the first day of menses) score < 3 on each of the 21 items during both the pretreatment screening cycle 2 and placebo run-in cycle 3. b.Subjects must have each qualifying symptom on at least 4 of 7 efficacy period days (the 6 days before menses through day 1 of menses [7 days total]):
- •- At least moderate (> or = 4) for at least 2 days
- •- At least mild (> or = 3) for at least 2 of the remaining days on 5 or more of the 11 PMDD symptoms during both the pretreatment screening cycle 2 and placebo run-in cycle 3, with at least 1 of the symptoms being either items 1 (a, b or c), (2), 3 (a or b), or 4 (a or b). c.Subjects must have an average daily efficacy period (the 6 days before menses through day 1 of menses [7 days total]) score > or = 50 with a > or = 50% increase from the previous average daily total follicular phase score to the efficacy period score during both the pretreatment screening cycle 2 and placebo run-in cycle 3.d.Subjects must have an efficacy period (the 6 days before menses through day 1 of menses [7 days total]) score of at least moderate (> or = 4) for at least 2 days on any of the 3 functional impairment items during both the pretreatment screening cycle 2 and placebo run-in cycle 3.
- •4.Subjects must not be at risk for pregnancy during the study, or they must be using an effective, nonhormonal method of birth control (eg, diaphragm, condom with spermicide, sterilization, or nonhormonal intrauterine device [IUD]) or must be practicing complete abstinence.
- •5. Subjects must have had regular (21 - to 35-day) menstrual cycles by history for the 2-month period preceding the pretreatment screening cycle 1 (visit 1).
- •6. Subjects must have a cervical cytological smear report of negative for intraepithelial lesion or malignancy. If atypical squamous cells of undetermined significance (ASCUS) is reported, the subject must have a negative test result for human papilloma virus (HPV). The cervical cytological smear must be performed at pretreatment screening cycle 1 (visit 1) or within 6 months of pretreatment screening cycle 1 (visit 1) provided that a copy of the report is available.
- •Are the trial subjects under 18?
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years)
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. The presence or history of the following will prevent enrollment:
- •Thrombophlebitis, thrombosis, thromboembolic disorders, deep vein thrombosis, pulmonary embolism, or known coagulopathy. Ischemic heart disease or myocardial infarction. Cerebrovascular disease, cardiovascular disease, or thrombogenic valvular heart disease. Headaches with focal neurological symptoms in the 90 days before visit 1.Known or suspected estrogen-dependent neoplasia, known or suspected carcinoma of the breast, or ovarian carcinoma.Undiagnosed abnormal genital bleeding within the past 180 days of pretreatment screening cycle 1 (visit 1).Major depressive disorder requiring antidepressant treatment or hospitalization, or associated with suicide attempt or risk for suicide within the last 3 years before pretreatment screening cycle 1 (visit 1). Known hypersensitivity to estrogens, progestins, or any components of the study medication.Use of depot medroxyprogesterone acetate (ie, Depo-Provera) within 6 months of pretreatment screening cycle 1 (visit 1) and for the duration of the study.Use of monthly hormonal contraceptive injections, a hormonal IUD, implantable contraceptive hormones, oral contraceptives, estrogens, progestins, androgens, or gonadotropin-releasing hormone (GnRH) analogs within 60 days of pretreatment screening cycle 1 (visit 1) and for the duration of the study.Use of any experimental drug or device or participation in another research study within 10 days of pretreatment screening cycle 1 (visit 1) and for the duration of the study. Use of antidepressants/anxiolytics including but not limited to, tricyclic antidepressants, selective serotonin reuptake inhibitors (excluding fluoxetine), selective serotonin and norepinephrine reuptake inhibitors (eg, venlafaxine), serotonin agonists, monoamine oxidase inhibitors, benzodiazepines, bupropion, nefazadone, mirtazipine, and herbal preparations (eg, St. John’s wort, kava) within 10 days of pretreatment screening cycle 1 (visit 1) and for the duration of the study.Use of fluoxetine within the 30 days of pretreatment screening cycle 1 (visit 1) and for the duration of the study.
- •2. The presence of any of the following will prevent enrollment:Hamilton Depression Rating Scale (HAM-D17) score >11 administered during pretreatment screening cycle 2, days 8 to 12 (visit 2).Diagnosis of a current Axis I psychiatric disorder, based on the Mini International Neuropsychiatric regarding major depressive episode criteria administered during pretreatment screening cycle 2, days 8 to 12 (visit 2).Seasonal affective disorder, bipolar depression, psychotic disorder, somatoform disorder, dysthymic disorder, schizophrenia, obsessive-compulsive disorder, or antisocial/borderline/schizotypal personality disorder.
研究者
相似试验
进行中（未招募）
1 期
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF A NOVEL CCR5 ANTAGONIST, UK-427,857, IN COMBINATION WITH OPTIMIZED BACKGROUND THERAPY VERSUS OPTIMIZED BACKGROUND THERAPY ALONE FOR THE TREATMENT OF ANTIRETROVIRAL EXPERIENCED, NON CCR5-TROPIC HIV-1 INFECTED SUBJECTSK-427,857 is an antagonist of the human chemokine receptor, and is intended to help prevent the development and progression of AIDS in individuals HIV-1 positive.EUCTR2004-001779-20-GBPfizer Limited186
进行中（未招募）
1 期
A Study of RO6885247 in Adult and Pediatric Patients with Spinal Muscular Atrophy (MOONFISH)MedDRA version: 18.0Level: PTClassification code 10041582Term: Spinal muscular atrophySystem Organ Class: 10010331 - Congenital, familial and genetic disordersSpinal Muscular AtrophyEUCTR2014-002246-41-ESRoche Farma S.A., en nombre de F. Hoffmann-La Roche Ltd.64
进行中（未招募）
1 期
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF DAXDILIMAB IN ADULT PARTICIPANTS WITH ACTIVE PROLIFERATIVE LUPUS NEPHRITISACTIVE PROLIFERATIVE LUPUS NEPHRITISMedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disordersEUCTR2022-001377-31-ESHorizon Therapeutics Ireland DAC210
进行中（未招募）
1 期
PROOF OF CONCEPT STUDY TO EVALUATE THE EFFECTS OF TASIMELTEON AND MATCHING PLACEBO IN TRAVELERS WITH JET LAG DISORDERJet Lag Disorder (JLD)MedDRA version: 20.0 Level: PT Classification code 10040984 Term: Sleep disorder System Organ Class: 10037175 - Psychiatric disordersEUCTR2016-002213-21-GBVanda Pharmaceuticals Inc90
进行中（未招募）
不适用
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 2 FIXED DOSES (50 mg, 100 mg) OF DESVENLAFAXINE SUSTAINED-RELEASE TABLETS IN ADULT OUTPATIENTS WITH MAJOR DEPRESSIVE DISORDERMajor Depressive Disorder in outpatientsEUCTR2005-005463-28-LTWyeth Pharmaceuticals France, Wyeth Research Division480