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
- Conditions
- Premenstrual dysphoric disorder (PMDD) affects 3% to 5% of menstruating women. PMDD is defined by markedly depressed mood, anxiety, and/or affective lability during the last week of the late luteal phase with absence of these symptoms in the postmenses week. These symptoms markedly interfere with work or school or with usual social activities and relationships with others. Suppression of ovarian cyclicity is known to alleviate symptoms of PMDD.
- Registration Number
- EUCTR2004-005173-27-DK
- Lead Sponsor
- Wyeth Research Division of Wyeth Pharmaceuticals Inc., Clinical Research and Development
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 55
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 the2-month period preceding the pretreatment screening cycle 1 (visit 1).
6. Subjects must have a cervical cytological smear report of negative forintraepithelial lesion or malignancy. If atypical squamous cells of undeterminedsignificance (ASCUS) is reported, the subject must have a negative test for humanpapilloma virus (HPV). The cervical cytological smear must be performed atpretreatment screening cycle 1 (visit 1) or within 6 months of pretreatmentscreening 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
The presence or history of the following will prevent enrollment:
1. 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method