Efficacy and Safety of Fixed Dose Combination of Drotaverine Hydrochloride (80 Mg) and Mefenamic Acid (250mg) Versus Mefenamic Acid (250mg) alone In The Treatment Of Primary Dysmenorrhea: Double-Blind, Randomized comparative study

Walter Bushnell Private Limited0 个研究点目标入组 280 人开始时间: 待定最近更新: 2021年11月24日

试验速览

暂无简介。

•Failure to meet all inclusion criteria
•Causes of secondary dysmenorrhea including endometriosis, pelvic inflammatory disease, adenomyosis, fibroids (myomas), endometrial polyps, cervical stenosis (after uterine or cervical surgery), functional ovarian cysts, benign or malignant tumors of ovary, bowel or bladder, or other site, Inflammatory bowel disease
•Pregnant and lactating women
•Any pelvic abnormality on physical examination including infection or inflammatory process
•Premenstrual syndrome (PMS), infertility, heavy menstrual flow or irregular cycles, dyspareunia
•Any previous clinical history of gastroduodenal ulcer, gastrointestinal bleeding, or gastroduodenal perforation
•Concomitant use of medications that are known to increase the likelihood of upper gastrointestinal adverse events (e.g. corticosteroids and anticoagulants)
•Presence of serious co-morbidity, such as cardiovascular disease, cerebrovascular disease, renal or hepatic impairment, history of venous disease, diabetes, or hypertension
•Patients with history of hypersensitivity to NSAID and/or drotaverine
•Women will also be excluded if they had used an intrauterine device or oral contraceptives within six months prior to the study and had received NSAIDs or analgesics within 48 h prior to study entry
•Patients participating in any other clinical trial

发起方

Walter Bushnell Private Limited