Comparison of use of Drotaverine Hydrochloride and Mefenamic Acid vs Mefenamic Acid in mensturating females

Phase 4

• Conditions: Health Condition 1: null- Primary Dysmenorrhea

• Registration Number: CTRI/2015/05/005796
• Lead Sponsor: Walter Bushnell Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 280

Inclusion Criteria

Patients with regular menstruation (28 ± 7 day cycle)

Patients with history of primary dysmenorrhoea

Patients ready to follow-up

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assessment of pain relief at different time intervals i.e 15, 30 minutes, 1, 2, 4, 8, 12, 24 and 48 hours after the first dose of study medication <br/ ><br>Total area under pain relief (PR) score up to 2, 4 and 8 hours (TOPAR/2, TOPAR/4 and TOPAR/8)Timepoint: Assessment of pain relief at different time intervals i.e 15, 30 minutes, 1, 2, 4, 8, 12, 24 and 48 hours after the first dose of study medication <br/ ><br>Total area under pain relief (PR) score up to 2, 4 and 8 hours (TOPAR/2, TOPAR/4 and TOPAR/8)

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Difference <br/ ><br>Sum of Pain Intensity Difference over 2, 4 and 8 hours <br/ ><br>Peak PID over 2, 4 and 8 h <br/ ><br>Peak PR over 2, 4 and 8 h <br/ ><br>Total study drug consumption <br/ ><br>Patientâ??s and investigatorâ??s global evaluation of the efficacyTimepoint: Pain Intensity Difference <br/ ><br>Sum of Pain Intensity Difference over 2, 4 and 8 hours <br/ ><br>Peak PID over 2, 4 and 8 h <br/ ><br>Peak PR over 2, 4 and 8 h <br/ ><br>Total study drug consumption <br/ ><br>Patientâ??s and investigatorâ??s global evaluation of the efficacy