CTRI/2010/091/001274已完成3 期
A DOUBLE-BLIND, DOUBLE ARM, RANDOMIZED, MULTICENTRIC, PROSPECTIVE, PHASE-III TRIAL TO INVESTIGATE THE EFFFICACY, SAFETY AND TOLERABILITYOF THE FIXED-DOSE COMBINATION OF PARACETAMOL 500MG AND PAMABROM 25mg WITH PARACETAMOL ALONE IN THE TREATMENT OF PATIENTS WITH PREMENSTRUAL SYNDROME
Akums Drugs & Pharmaceuticals Limited ., Delhi0 个研究点目标入组 200 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •■All patients with duly filled in ICFs [Informed Consent Forms]
- •■Ages: > 18 till menopause
- •■Genders Eligible for Study: only women
- •■Established diagnosis of the premenstrual syndrome
排除标准
- •?Patients unwilling to sign on ICF
- •?Participation in other trials,
- •?Concomitant therapy,
- •?Pregnancy or breast feeding,
- •?Inadequate contraception,
- •?Alcohol or drug dependence,
- •?Concomitant serious medical condition,
- •?Hypersensitivity to Pamabrom or paracetamol,
- •?Pituitary disease, and
- •?Concomitant use of sex hormones except oral contraceptives for which the doses will be unchanged.
- •?Any other serious diseases having fatal progression.
- •?Any of the following endocrinological diseases: diabetes mellitus, hypo-/hyperthyreosis, pituitary tumor.
- •?Clearly kidney or liver disease, abnormal kidney or liver function.
- •?Any of the following gynecological diseases: endometriosis, mammary carcinoma, intraductal papilloma, galactorrhea, mammary fibroadenoma.
- •?Prior to the start of the study any planned surgical intervention of the breasts (including cyst puncture), of the uterus and/ or adnexa.
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